SpondyloarthritisExeHeartNCT04922840
Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases
A study testing High-intensity exercise (HIIT) in people with Spondyloarthritis and Rheumatoid Arthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
Inflammatory joint diseases (IJD) are autoimmune diseases with common symptoms of joint inflammation, pain, stiffness and fatigue. Compared to the general population, this large patient-group has an increased risk of cardiovascular disease (CVD) and CVD-related mortality. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spondyloarthritis, Rheumatoid Arthritis, Psoriatic Arthritis
- What is being tested?
- High-intensity exercise (HIIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 9 Aug 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70
- BMI: 18.5-40
- Inflammatory joint disease verified by physician
- Able to walk unaided and continuously for ≥ 15 min.
- Norwegian or English speaking
Who cannot join
- Sustained lower extremity injury ≤12 months, including surgery
- Neurological disease
- Absolute contraindication to maximal exercise test
- Cognitive impairment
- Participation in structured high-intensity exercise ≥ 1/week in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Inflammatory joint diseases (IJD) are autoimmune diseases with common symptoms of joint inflammation, pain, stiffness and fatigue. Compared to the general population, this large patient-group has an increased risk of cardiovascular disease (CVD) and CVD-related mortality. Patients with IJD call for improved CVD screening and risk management as well as access to evidence-based non-pharmacological treatment alternatives. Evidence supports high intensity training (HIIT) in mitigating risk of CVD and inflammation, but the evidence of these cardioprotective benefits is unclear in patients with IJD and the feasibility of HIIT protocols in daily clinical care needs to be addressed. Cardiorespiratory fitness (CRF) is an important physiological marker and highly correlated to risk of CVD. Despite strong recommendations, routine assessment of CRF is seldom performed in clinical care.
The ExeHeart study will assess the potential cardioprotective and disease-modifying effect of HIIT in IJD in a randomized controlled trial. Furthermore, the ExeHeart-study will report on the validity of non-exercise measures of cardiorespiratory fitness (eCRF) measures for use in daily clinical care. Additionally, we will explore the feasibility of HIIT by addressing adherence and fidelity to the HIIT treatment protocol in a primary care setting
Read the detailed description
The study is a two-armed randomized controlled trial (RCT). Patients aged 18-70 years presenting with inflammatory joint disease at the Preventive Cardio-Rheuma clinic at Diakonhjemmet hospital (Oslo) will be included if eligible for the study. Succeeding baseline testing, participants are randomized to either experimental group (high-intensity exercise-HIIT) or control group (usual care).
The research questions are:
- Is a 12-week HIIT program effective on VO2peak, inflammatory markers and risk of cardiovascular disease in patients with inflammatory joint disease and what is the association between VO2peak and disease-specific and cardiovascular disease-related variables?
- Is a non-exercise cardio-respiratory fitness algorithm (eCRF) valid in determining longitudinal change in VO2peak in patients with inflammatory joint disease?
- How feasible is a HIIT intervention in primary care in patients with inflammatory joint disease in terms of adherence and fidelity to the exercise program?
The primary analysis will be a between group comparison of VO2peak levels. This will be carried out according to the intention-to-treat principle, and done by the analysis of covariance (ANCOVA), adjusting for VO2peak values at baseline along with stratification factors used in the randomization. Secondary analyses will include between group comparisons on secondary endpoints, as well as comparisons in the per protocol population. No adjustment for multiple testing will be done.
The association between VO2peak and changes in inflammatory markers, disease activity and CVD risk will be assessed using multiple regression.
The validity of eCRF models to accurately detect longitudinal change in VO2peak from baseline to 3-month and 6-month follow-up will be assessed with Pearson or Spearman correlation by comparing VO2peak derived from a cardiopulmonary exercise test to eCRF.
The feasibility of a HIIT program and adherence will be examined with descriptive statistics. Adherence to the prescribed HIIT intervention will be recorded by attendance to exercise sessions. Quality of treatment delivery will be quantified as the number of exercise sessions complying with the planned exercise intensity and number of exercise sessions requiring dose modifications such as lower exercise intensity or early session termination. At the 3-month timepoint, an electronic questionnaire will be distributed to patients in the HIIT group. Questions regarding feasibility and implementation fidelity will address patients' acceptability and satisfaction with the HIIT program. The ExeHeart study will also include semi-structured interviews, targeting physiotherapists in charge of supervising the exercise sessions and 5-7 patients in the intervention group. The interviews will explore barriers and facilitators in exercise adherence, experience with the protocol and perceived effects of exercise.
- Conditions
- Spondyloarthritis, Rheumatoid Arthritis, Psoriatic Arthritis
- Being tested
- High-intensity exercise (HIIT)
- Keywords
- Exercise, Cardiovascular disease, Cardiovascular risk, High-intensity training, Physiotherapy, High-intensity exercise, Inflammatory joint disease
- Medical subject headings
- Spondylarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic, Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity exercise (HIIT)Behavioural
12 week intervention: Two weekly sessions of 35-40 min exercise: 10 min warm-up, followed by 4x4 min at 90-95% peak heart rate (HRpeak) interspaced by 2-3 min active breaks at 60-70% HRpeak and a third weekly session with continuous exercise for a minimum of 40 min at moderate intensity.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity exercise (HIIT) | Experimental | Usual care; CVD risk assessment, lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication.
The 12-week intervention is carried out as individual or group sessions with maximal 4 patients, supervised by physiotherapists in primary health care. The HIIT group complete two weekly HIIT sessions and a third weekly session with exercise at moderate intensity. Exercise is tailored to each individual to provide the same relative exercise stress and to ensure progression. Target exercise intensity is tracked by a heart rate monitor.
Individual exercise session are recorded in a training diary. Succeeding the intervention, a questionnaire will be distributed to patients in the HIIT group. Semi-structured interviews will target physiotherapists supervising HIIT and 5-7 patients in the HIIT group. Receives: Behavioral: High-intensity exercise (HIIT) |
| Usual care | No intervention | Control group participants receive the same treatment as usual care; CVD risk assessment including lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication. Control group participants are invited to a physiotherapist-led theoretical and practical HIIT session following study completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake - VO2peak ml/kg/min
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Measured: 3 months post baseline
Secondary outcomes (170)
Peak oxygen uptake - VO2peak L/min
VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Measured: 3 months post baseline
Peak oxygen uptake - VO2peak ml/kg/min
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Measured: Baseline
Peak oxygen uptake - VO2peak ml/kg/min
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Measured: 6 months post baseline
Peak oxygen uptake - VO2peak L/min
VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Measured: Baseline
Peak oxygen uptake - VO2peak L/min
VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Measured: 6 months post baseline
Change in VO2peak (ml/kg/min) from baseline to 3 months past baseline
Change in VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute from baseline to 6 months (3 months post intervention) . VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Measured: 3 months post baseline
Change in VO2peak (ml/kg/min) from baseline to 6 months post baseline
Change in VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute from baseline to 6 months (3 months post intervention) . VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Measured: 6 months
Change in VO2peak L/min from baseline to 3 months post baseline
VO2peak, expressed in liters per minute(L/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Measured: 3 months post baseline
Change in VO2peak L/min from baseline to 6 months post baseline
VO2peak, expressed in liters per minute(L/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Measured: 6 months post baseline
Body composition
Body scan to estimate total and regional distribution of lean body mass and fat mass
Measured: Baseline
Body composition
Body scan to estimate total and regional distribution of lean body mass and fat mass
Measured: 3 months post baseline
Body composition
Body scan to estimate total and regional distribution of lean body mass and fat mass
Measured: 6 months post baseline
Ventilatory threshold 1
Point during at which ventilation starts to increase at a faster rate than VO2 - derived from CPET
Measured: Baseline
Ventilatory threshold 1
Point during exercise at which ventilation starts to increase at a faster rate than VO2 - derived from CPET
Measured: 3 months post baseline
Ventilatory threshold 1
Point during exercise at which ventilation starts to increase at a faster rate than volume of oxygen (VO2) - derived from CPET
Measured: 6 months post baseline
Ventilatory threshold 2
The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET
Measured: Baseline
Ventilatory threshold 2
The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET
Measured: 3 months post baseline
Ventilatory threshold 2
The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET
Measured: 6 months post baseline
Breathing reserve
Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET
Measured: Baseline
Breathing reserve
Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET
Measured: 3 months post baseline
Breathing reserve
Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET
Measured: 6 months post baseline
Oxygen pulse
The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.
Measured: Baseline
Oxygen pulse
The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.
Measured: 3 months post baseline
Oxygen pulse
The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.
Measured: 6 months post baseline
Ventilatory equivalents for oxygen (VE/VO2)
Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET
Measured: Baseline
Ventilatory equivalents for oxygen (VE/VO2)
Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET
Measured: 3 months post baseline
Ventilatory equivalents for oxygen (VE/VO2)
Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET
Measured: 6 months post baseline
Ventilatory equivalents for carbon dioxide(VE/VCO2)
Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET
Measured: Baseline
Ventilatory equivalents for carbon dioxide(VE/VCO2)
Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET
Measured: 3 months post baseline
Ventilatory equivalents for carbon dioxide (VE/VCO2)
Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET
Measured: 6 months post baseline
Respiratory Exchange Ratio (RER)
Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET
Measured: Baseline
Respiratory Exchange Ratio (RER)
Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET
Measured: 3 months post baseline
Respiratory Exchange Ratio (RER)
Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET
Measured: 6 months post baseline
Blood lactate concentration
Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes
Measured: Baseline
Blood lactate concentration
Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes
Measured: 3 months post baseline
Blood lactate concentration
Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes
Measured: 6 months post baseline
C-Reactive protein
Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein
Measured: Baseline
C-Reactive protein
Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein
Measured: 3 months post baseline
C-Reactive protein
Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein
Measured: 6 months post baseline
Erythrocyte Sedimentation Rate
Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate
Measured: Baseline
Erythrocyte Sedimentation Rate
Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate
Measured: 3 months post baseline
Erythrocyte Sedimentation Rate
Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate
Measured: 6 months post baseline
Total cholesterol
Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol
Measured: Baseline
Total cholesterol
Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol
Measured: 3 months post baseline
Total cholesterol
Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol
Measured: 6 months post baseline
High-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins
Measured: Baseline
High-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins
Measured: 3 months post baseline
High-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins
Measured: 6 months post baseline
Low-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins
Measured: Baseline
Low-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins
Measured: 3 months post baseline
Low-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins
Measured: 6 months post baseline
Triglycerides
Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides
Measured: Baseline
Triglycerides
Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides
Measured: 3 months post baseline
Triglycerides
Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides
Measured: 6 months post baseline
Blood pressure
Supine systolic and diastolic blood pressure
Measured: Baseline
Blood pressure
Supine systolic and diastolic blood pressure
Measured: 3 months post baseline
Blood pressure
Supine systolic and diastolic blood pressure
Measured: 6 months post baseline
Body Mass Index
Weight in kilograms divided by the square of height in meters
Measured: Baseline
Body Mass Index
Weight in kilograms divided by the square of height in meters
Measured: 3 months post baseline
Body Mass Index
Weight in kilograms divided by the square of height in meters
Measured: 6 months post baseline
Waist circumference
Waist girth in centimeters. Measured in a standing position after a full exhale.
Measured: Baseline
Waist circumference
Waist girth in centimeters. Measured in a standing position after a full exhale.
Measured: 3 months post baseline
Waist circumference
Waist girth in centimeters. Measured in a standing position after a full exhale.
Measured: 6 months post baseline
Resting heart rate
Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench
Measured: Baseline
Resting heart rate
Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench
Measured: 3 months post baseline
Resting heart rate
Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench
Measured: 6 months post baseline
Health-related quality of life, EuroQoL (EQ5D-5L)
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Measured: Baseline
Health-related quality of life, EuroQoL (EQ5D-5L)
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Measured: 3 months post baseline
Health-related quality of life, EuroQoL (EQ5D-5L)
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Measured: 6 months post baseline
Frequency of medication
Usage of medications last three months. Measured in frequency.
Measured: Baseline
Dosage of medication
Usage of medications last three months. Measured in dosage.
Measured: Baseline
Dosage of medication
Usage of medications last three months. Measured in dosage
Measured: 3 months post baseline
Frequency of medication
Usage of medications last three months. Measured in frequency
Measured: 3 months post baseline
Dosage of medication
Usage of medications last three months. Measured in dosage.
Measured: 6 months post baseline
Frequency of medication
Usage of medications last three months. Measured in frequency.
Measured: 6 months post baseline
Self-reported fatigue
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Measured: Baseline
Self-reported fatigue
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Measured: 3 months post baseline
Self-reported fatigue
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Measured: 6 months post baseline
Self-reported pain
Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Baseline
Self-reported pain
Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 3 months post baseline
Self-reported pain
Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 6 months post baseline
Self-reported physical activity (HUNT)
Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.
Measured: Baseline
Self-reported physical activity (HUNT)
Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.
Measured: 3 months post baseline
Self-reported physical activity (HUNT)
Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.
Measured: 6 months post baseline
SCORE2
Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.
Measured: Baseline
SCORE2
Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.
Measured: 3 months post baseline
SCORE2
Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.
Measured: 6 months post baseline
Forced vital capacity
Volume of air that can be forcefully exhaled after a full inspiration, measured in liters. Obtained from spirometry
Measured: Baseline
Forced vital capacity
Volume of air that can be forcefully exhaled after a full inspiration, measured in liters- obtained from spirometry
Measured: 3 months post baseline
Forced vital capacity
Volume of air that can be forcefully exhaled after a full inspiration, measured in liters- obtained from spirometry
Measured: 6 months post baseline
Forced expiratory volume in 1 second (FEV1)
Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry
Measured: Baseline
Forced expiratory volume in 1 second (FEV1)
Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry
Measured: 3 months post baseline
Forced expiratory volume in 1 second (FEV1)
Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry
Measured: 6 months post baseline
FEV1/FVC ratio
Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)
Measured: Baseline
FEV1/FVC ratio
Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)
Measured: 3 months post baseline
FEV1/FVC ratio
Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)
Measured: 6 months post baseline
Forced expiratory flow
Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry
Measured: Baseline
Forced expiratory flow
Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry
Measured: 3 months post baseline
Forced expiratory flow
Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry
Measured: 6 months post baseline
Peak expiratory flow (PEF)
Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry
Measured: Baseline
Peak expiratory flow (PEF)
Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry
Measured: 3 months post baseline
Peak expiratory flow (PEF)
Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry
Measured: 6 months post baseline
Maximum voluntary ventilation (MVV)
Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry
Measured: Baseline
Maximum voluntary ventilation (MVV)
Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry
Measured: 3 months post baseline
Maximum voluntary ventilation (MVV)
Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry
Measured: 6 months post baseline
Psoriatic Arthritis Impact of Disease (PsAID)
Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with psoriatic arthritis.
Measured: Baseline
Psoriatic Arthritis Impact of Disease (PsAID)
Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants psoriatic arthritis.
Measured: 3 months post baseline
Psoriatic Arthritis Impact of Disease (PsAID)
Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with psoriatic arthritis.
Measured: 6 months post baseline
Rheumatoid arthritis impact of disease (RAID)
Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.
Measured: Baseline
Rheumatoid arthritis impact of disease (RAID)
Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.
Measured: 3 months post baseline
Rheumatoid arthritis impact of disease (RAID)
Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.
Measured: 6 months post baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Measured: Baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Measured: 3 months post baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Measured: 6 months post baseline
Bath Ankylosing Spondylitis Functional Index (BASFI)
Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Measured: Baseline
Bath Ankylosing Spondylitis Functional Index (BASFI)
Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Measured: 3 months post baseline
Bath Ankylosing Spondylitis Functional Index (BASFI)
Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Measured: 6 months post baseline
Bath Ankylosing Spondylitis Global Score (BAS-G)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Measured: Baseline
Bath Ankylosing Spondylitis Global Score (BAS-G)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Measured: 3 months post baseline
Bath Ankylosing Spondylitis Global Score (BAS-G)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Measured: 6 months post baseline
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.
Measured: 3 months post baseline
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.
Measured: 6 months post baseline
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.
Measured: Baseline
Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)
Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.
Measured: Baseline
Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)
Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.
Measured: 3 months post baseline
Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)
Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.
Measured: 6 months post baseline
Disease Activity in PSoriatic Arthritis (DAPSA)
Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis
Measured: Baseline
Disease Activity in PSoriatic Arthritis (DAPSA)
Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis
Measured: 3 months post baseline
Disease Activity in PSoriatic Arthritis (DAPSA)
Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis
Measured: 6 months post baseline
Post-exercise questionnaire
Electronic questionnaire distributed to patients in the experimental group upon completion of HIT intervention. 14 statements related to participation in the HIT exercise intervention and perceived intensity, duration and frequency of the exercise intervention. Scored on a 5 point Likert scale ranging from strongly disagree to strongly agree.
Measured: 3 months post baseline
Use of healthcare services
Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.
Measured: Baseline
Use of healthcare services
Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.
Measured: 3 months post baseline
Use of healthcare services
Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.
Measured: 6 months post baseline
Smoking status
Registered by self-report; I smoke daily, I am a former smoker , I have never smoked
Measured: Baseline
Smoking status
Registered by self-report; I smoke daily, I am a former smoker , I have never smoked
Measured: 3 months post baseline
Smoking status
Registered by self-report; I smoke daily, I am a former smoker , I have never smoked
Measured: 6 months post baseline
Snuff status
Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff
Measured: Baseline
Snuff status
Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff
Measured: 3 months post baseline
Snuff status
Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff
Measured: 6 months post baseline
Peak heart rate
Peak heart rate observed during CPET
Measured: Baseline
Peak heart rate
Peak heart rate observed during CPET
Measured: 3 months post baseline
Peak heart rate
Peak heart rate observed during CPET
Measured: 6 months post baseline
Augmentation index
Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure
Measured: Baseline
Augmentation index
Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure
Measured: 3 months post baseline
Augmentation index
Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure
Measured: 6 months post baseline
Pulse Wave Velocity
Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure
Measured: Baseline
Pulse Wave Velocity
Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure
Measured: 3 months post baseline
Pulse Wave Velocity
Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure
Measured: 6 months post baseline
Exercise self-efficacy
Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.
Measured: Baseline
Exercise self-efficacy
Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.
Measured: 3 months post baseline
Exercise self-efficacy
Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.
Measured: 6 months post baseline
Exercise frequency
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise frequency is recorded.
Measured: 3 months post baseline
Exercise intensity
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise intensity is recorded by use of a herat rate monitor.
Measured: 3 months post baseline
Exercise duration
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise duration is recorded.
Measured: 3 months post baseline
Early session termination
Participants in the experimental group are asked to record individual exercise session in a training diary. Early session termination is recorded.
Measured: 3 months post baseline
Exercise-related adverse events
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise-related adverse events are recorded.
Measured: 3 months post baseline
Self-reported cardiovascular health and symptoms
13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided
Measured: Baseline
Self-reported cardiovascular health and symptoms
13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided
Measured: 3 months post baseline
Self-reported cardiovascular health and symptoms
13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided
Measured: 6 months post baseline
Self-report change in physical fitness
Patient global change in self-perceived physical fitness measured on a 5-point Likert scale ranging from much better to much worse
Measured: 3 months post baseline
Self-report change in physical fitness
Patient global change in self-perceived physical fitness measured on a 5-point Likert scale ranging from much better to much worse
Measured: 6 months post baseline
Self-report exercise habits
Questionnaire; self-report of exercise habits from baseline to 3 months post baseline: Participation in regular exercise (yes/no), if yes: frequency (1-2 times/week, 3-4 times/week, 5 times or more/week) and mode of exercise (endurance exercise, strength exercise, mobility exercise and/or other).
These questions are only forwarded to participants in the control group at this timepoint. Exercise habits form baseline to 3 months post baseline is recorded via the training diary for participants allocated to HIIT (experimental group): see outcome 153-157.
Measured: 3 months post baseline
Self-report exercise habits
Questionnaire; self-report of exercise habits from 3 months post baseline to 6 months post-baseline: Participation in regular exercise (yes/no), if yes: frequency (1-2 times/week, 3-4 times/week, 5 times or more/week) and mode of exercise (endurance exercise, strength exercise, mobility exercise and/or other).
These questions are forwarded to all study participants at this timepoint.
Measured: 6 months post baseline
Corona virus 19 infection
Questionnaire; self-report regarding corona virus 19 infection (yes/no, if yes: hospitalization/no hospitalization) from baseline to 3 months post baseline
Measured: 3 months post baseline
Corona virus 19 infection
Questionnaire; self-report regarding corona virus 19 infection (yes/no, if yes: hospitalization/no hospitalization) from 3 months post baseline to 6 montsh post baseline
Measured: 6 months post baseline
Corona virus 19 quarantine
Questionnaire; self-report regarding corona virus 19 quarantine (yes/no) from baseline to 3 months post baseline
Measured: 3 months post baseline
Corona virus 19 quarantine
Questionnaire; self-report regarding corona virus 19 quarantine (yes/no) from 3 months post baseline to 6 months post baseline
Measured: 6 months post baseline
Maximum minute ventilation at peak exercise (VEmax, L/min)
Maximum ventilation, recorded from CPET at peak exercise
Measured: Baseline
Maximum minute ventilation at peak exercise (VEmax, L/min)
Maximum ventilation, recorded from CPET at peak exercise
Measured: 3 months post baseline
Maximum minute ventilation at peak exercise (VEmax, L/min)
Maximum ventilation, recorded from CPET at peak exercise
Measured: 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start9 Aug 2021
- Primary completion20 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated 1:1 according to a computer-generated randomization scheme, stratified by sex
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation, The Norwegian Rheumatism Association, Norwegian Health Association
- Responsible party
- Principal investigator, Anne Therese Tveter, Diakonhjemmet Hospital
- Investigators
- Anne Therese Tveter, PhD, Principal investigator, National Resource Center for Rehabilitation in Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922840
- Sponsor's protocol ID
- 2021/FO347439
- Acronym
- ExeHeart
- Status last verified
- Mar 2023
- First submitted
- 15 May 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be made available upon sound request to the principal investigator
Publications
Norden KR, Semb AG, Dagfinrud H, Hisdal J, Sexton J, Fongen C, Bakke E, Odegard S, Skandsen J, Blanck T, Metsios GS, Tveter AT. Effect of high-intensity interval training in physiotherapy primary care for patients with inflammatory arthritis: the ExeHeart randomised controlled trial. RMD Open. 2024 Jan 18;10(1):e003440. doi: 10.1136/rmdopen-2023-003440.
PubMed 38242550Norden KR, Semb AG, Dagfinrud H, Hisdal J, Odegard S, Sexton J, Fongen C, Skandsen J, Blanck T, Metsios GS, Tveter AT. Associations between cardiovascular risk factors, disease activity and cardiorespiratory fitness in patients with inflammatory joint disease: a cross-sectional analysis. BMC Sports Sci Med Rehabil. 2023 Apr 21;15(1):63. doi: 10.1186/s13102-023-00678-4.
PubMed 37085935Norden KR, Dagfinrud H, Semb AG, Hisdal J, Viktil KK, Sexton J, Fongen C, Skandsen J, Blanck T, Metsios GS, Tveter AT. Effect of high-intensity exercise on cardiorespiratory fitness, cardiovascular disease risk and disease activity in patients with inflammatory joint disease: protocol for the ExeHeart randomised controlled trial. BMJ Open. 2022 Feb 17;12(2):e058634. doi: 10.1136/bmjopen-2021-058634.
PubMed 35177467
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases
- ClinicalTrials.gov ID
- NCT04922840
- Acronym / sponsor ID
- ExeHeart / 2021/FO347439
- Conditions
- Spondyloarthritis, Rheumatoid Arthritis, Psoriatic Arthritis
- Keywords
- Exercise, Cardiovascular disease, Cardiovascular risk, High-intensity training, Physiotherapy, High-intensity exercise, Inflammatory joint disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- The Dam Foundation, The Norwegian Rheumatism Association, Norwegian Health Association
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inflammatory joint diseases (IJD) are autoimmune diseases with common symptoms of joint inflammation, pain, stiffness and fatigue. Compared to the general population, this large patient-group has an increased risk of cardiovascular disease (CVD) and CVD-related mortality. Patients with IJD call for improved CVD screening and risk management as well as access to evidence-based non-pharmacological treatment alternatives. Evidence supports high intensity training (HIIT) in mitigating risk of CVD and inflammation, but the evidence of these cardioprotective benefits is unclear in patients with IJD and the feasibility of HIIT protocols in daily clinical care needs to be addressed. Cardiorespiratory fitness (CRF) is an important physiological marker and highly correlated to risk of CVD. Despite strong recommendations, routine assessment of CRF is seldom performed in clinical care.
The ExeHeart study will assess the potential cardioprotective and disease-modifying effect of HIIT in IJD in a randomized controlled trial. Furthermore, the ExeHeart-study will report on the validity of non-exercise measures of cardiorespiratory fitness (eCRF) measures for use in daily clinical care. Additionally, we will explore the feasibility of HIIT by addressing adherence and fidelity to the HIIT treatment protocol in a primary care setting
Detailed description
The study is a two-armed randomized controlled trial (RCT). Patients aged 18-70 years presenting with inflammatory joint disease at the Preventive Cardio-Rheuma clinic at Diakonhjemmet hospital (Oslo) will be included if eligible for the study. Succeeding baseline testing, participants are randomized to either experimental group (high-intensity exercise-HIIT) or control group (usual care).
The research questions are:
- Is a 12-week HIIT program effective on VO2peak, inflammatory markers and risk of cardiovascular disease in patients with inflammatory joint disease and what is the association between VO2peak and disease-specific and cardiovascular disease-related variables?
- Is a non-exercise cardio-respiratory fitness algorithm (eCRF) valid in determining longitudinal change in VO2peak in patients with inflammatory joint disease?
- How feasible is a HIIT intervention in primary care in patients with inflammatory joint disease in terms of adherence and fidelity to the exercise program?
The primary analysis will be a between group comparison of VO2peak levels. This will be carried out according to the intention-to-treat principle, and done by the analysis of covariance (ANCOVA), adjusting for VO2peak values at baseline along with stratification factors used in the randomization. Secondary analyses will include between group comparisons on secondary endpoints, as well as comparisons in the per protocol population. No adjustment for multiple testing will be done.
The association between VO2peak and changes in inflammatory markers, disease activity and CVD risk will be assessed using multiple regression.
The validity of eCRF models to accurately detect longitudinal change in VO2peak from baseline to 3-month and 6-month follow-up will be assessed with Pearson or Spearman correlation by comparing VO2peak derived from a cardiopulmonary exercise test to eCRF.
The feasibility of a HIIT program and adherence will be examined with descriptive statistics. Adherence to the prescribed HIIT intervention will be recorded by attendance to exercise sessions. Quality of treatment delivery will be quantified as the number of exercise sessions complying with the planned exercise intensity and number of exercise sessions requiring dose modifications such as lower exercise intensity or early session termination. At the 3-month timepoint, an electronic questionnaire will be distributed to patients in the HIIT group. Questions regarding feasibility and implementation fidelity will address patients' acceptability and satisfaction with the HIIT program. The ExeHeart study will also include semi-structured interviews, targeting physiotherapists in charge of supervising the exercise sessions and 5-7 patients in the intervention group. The interviews will explore barriers and facilitators in exercise adherence, experience with the protocol and perceived effects of exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be allocated 1:1 according to a computer-generated randomization scheme, stratified by sex
| Arm | Type | Receives |
|---|---|---|
| High-intensity exercise (HIIT) | Experimental | Behavioral: High-intensity exercise (HIIT)Usual care; CVD risk assessment, lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication. The 12-week intervention is carried out as individual or group sessions with maximal 4 patients, supervised by physiotherapists in primary health care. The HIIT group complete two weekly HIIT sessions and a third weekly session with exercise at moderate intensity. Exercise is tailored to each individual to provide the same relative exercise stress and to ensure progression. Target exercise intensity is tracked by a heart rate monitor. Individual exercise session are recorded in a training diary. Succeeding the intervention, a questionnaire will be distributed to patients in the HIIT group. Semi-structured interviews will target physiotherapists supervising HIIT and 5-7 patients in the HIIT group. |
| Usual care | No intervention | –Control group participants receive the same treatment as usual care; CVD risk assessment including lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication. Control group participants are invited to a physiotherapist-led theoretical and practical HIIT session following study completion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-70
- BMI: 18.5-40
- Inflammatory joint disease verified by physician
- Able to walk unaided and continuously for ≥ 15 min.
- Norwegian or English speaking
Key exclusion criteria (5 listed)
- Sustained lower extremity injury ≤12 months, including surgery
- Neurological disease
- Absolute contraindication to maximal exercise test
- Cognitive impairment
- Participation in structured high-intensity exercise ≥ 1/week in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity exercise (HIIT)12 week intervention: Two weekly sessions of 35-40 min exercise: 10 min warm-up, followed by 4x4 min at 90-95% peak heart rate (HRpeak) interspaced by 2-3 min active breaks at 60-70% HRpeak and a third weekly session with continuous exercise for a minimum of 40 min at moderate intensity. | Behavioural | High-intensity exercise (HIIT) |
Primary outcome
Peak oxygen uptake - VO2peak ml/kg/min
Time frame: 3 months post baseline
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
170 secondary outcomes
Peak oxygen uptake - VO2peak L/min
Time frame: 3 months post baseline
Peak oxygen uptake - VO2peak ml/kg/min
Time frame: Baseline
Peak oxygen uptake - VO2peak ml/kg/min
Time frame: 6 months post baseline
Peak oxygen uptake - VO2peak L/min
Time frame: Baseline
Peak oxygen uptake - VO2peak L/min
Time frame: 6 months post baseline
Change in VO2peak (ml/kg/min) from baseline to 3 months past baseline
Time frame: 3 months post baseline
Change in VO2peak (ml/kg/min) from baseline to 6 months post baseline
Time frame: 6 months
Change in VO2peak L/min from baseline to 3 months post baseline
Time frame: 3 months post baseline
Change in VO2peak L/min from baseline to 6 months post baseline
Time frame: 6 months post baseline
Body composition
Time frame: Baseline
Body composition
Time frame: 3 months post baseline
Body composition
Time frame: 6 months post baseline
Ventilatory threshold 1
Time frame: Baseline
Ventilatory threshold 1
Time frame: 3 months post baseline
Ventilatory threshold 1
Time frame: 6 months post baseline
Ventilatory threshold 2
Time frame: Baseline
Ventilatory threshold 2
Time frame: 3 months post baseline
Ventilatory threshold 2
Time frame: 6 months post baseline
Breathing reserve
Time frame: Baseline
Breathing reserve
Time frame: 3 months post baseline
Breathing reserve
Time frame: 6 months post baseline
Oxygen pulse
Time frame: Baseline
Oxygen pulse
Time frame: 3 months post baseline
Oxygen pulse
Time frame: 6 months post baseline
Ventilatory equivalents for oxygen (VE/VO2)
Time frame: Baseline
Ventilatory equivalents for oxygen (VE/VO2)
Time frame: 3 months post baseline
Ventilatory equivalents for oxygen (VE/VO2)
Time frame: 6 months post baseline
Ventilatory equivalents for carbon dioxide(VE/VCO2)
Time frame: Baseline
Ventilatory equivalents for carbon dioxide(VE/VCO2)
Time frame: 3 months post baseline
Ventilatory equivalents for carbon dioxide (VE/VCO2)
Time frame: 6 months post baseline
Respiratory Exchange Ratio (RER)
Time frame: Baseline
Respiratory Exchange Ratio (RER)
Time frame: 3 months post baseline
Respiratory Exchange Ratio (RER)
Time frame: 6 months post baseline
Blood lactate concentration
Time frame: Baseline
Blood lactate concentration
Time frame: 3 months post baseline
Blood lactate concentration
Time frame: 6 months post baseline
C-Reactive protein
Time frame: Baseline
C-Reactive protein
Time frame: 3 months post baseline
C-Reactive protein
Time frame: 6 months post baseline
Erythrocyte Sedimentation Rate
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Derived from this study: PubMed 38242550Norden KR, Semb AG, Dagfinrud H, Hisdal J, Sexton J, Fongen C, Bakke E, Odegard S, Skandsen J, Blanck T, Metsios GS, Tveter AT. Effect of high-intensity interval training in physiotherapy primary care for patients with inflammatory arthritis: the ExeHeart randomised controlled trial. RMD Open. 2024 Jan 18;10(1):e003440. doi: 10.1136/rmdopen-2023-003440.
- Derived from this study: PubMed 37085935Norden KR, Semb AG, Dagfinrud H, Hisdal J, Odegard S, Sexton J, Fongen C, Skandsen J, Blanck T, Metsios GS, Tveter AT. Associations between cardiovascular risk factors, disease activity and cardiorespiratory fitness in patients with inflammatory joint disease: a cross-sectional analysis. BMC Sports Sci Med Rehabil. 2023 Apr 21;15(1):63. doi: 10.1186/s13102-023-00678-4.
- Derived from this study: PubMed 35177467Norden KR, Dagfinrud H, Semb AG, Hisdal J, Viktil KK, Sexton J, Fongen C, Skandsen J, Blanck T, Metsios GS, Tveter AT. Effect of high-intensity exercise on cardiorespiratory fitness, cardiovascular disease risk and disease activity in patients with inflammatory joint disease: protocol for the ExeHeart randomised controlled trial. BMJ Open. 2022 Feb 17;12(2):e058634. doi: 10.1136/bmjopen-2021-058634.
- Effect of high-intensity exercise on cardiorespiratory fitness, cardiovascular disease risk and disease activity in patients with inflammatory joint disease: protocol for the ExeHeart randomised controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data may be made available upon sound request to the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Therese Tveter, PhD principal investigator
National Resource Center for Rehabilitation in Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity exercise (HIIT) in people with Spondyloarthritis and Rheumatoid Arthritis, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake - VO2peak ml/kg/min (time frame: 3 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04922840, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.