Lupus Erythematosus, SystemicSLE-HIITNCT06166199
Effects of High-intensity Interval Training in Patients With Systemic Lupus Erythematosus
A study testing HIIT combined with resistance training in people with Lupus Erythematosus, Systemic, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate the safety and effects of high-intensity interval training (HIIT) combined with resistance training in patients with systemic lupus erythematosus Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- HIIT combined with resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Fulfilment of the 1982 American College of Rheumatology (ACR) criteria; or 2012 Systemic Lupus International Collaborating Clinics (SLICC/ACR-Damage Index (DI)) classification criteria; or EULAR/ACR criteria; or patients that have received the diagnosis SLE on clinical grounds
- Low to moderate disease activity, for example defined as a score of ≤5 in the clinical version of the SLE Disease Activity Index 2000 (SLEDAI-2K), i.e., excluding the serological descriptors (anti-dsDNA positivity and low complement levels)
- Low/minimal or no organ damage, for example defined as a score of ≤3 in the SLICC/ACR DI
- Stable pharmacological treatment
- The ability to perform a maximal ergometercycle exercise test
- Be able to read and understand Swedish
Who cannot join
- Symptoms or signs of cerebro-vascular disease, pulmonary embolus, pulmonary hypertension, pulmonary fibrosis, cardiovascular disease, angina pectoris, myocardial infarction, dyspnea at rest, uncontrolled blood pressure and uncontrolled diabetes within one year prior to study entry. Chronic kidney disease with
- Patients who fulfil the absolute contraindications for maximal exercise testing according to American Heart Association
- Patients who cannot perform a maximal ergometercycle exercise test due to the disease
- Diseases or other conditions that strongly reduce the ability to exercise or that exercise is not recommended
- Patients who perform regular aerobic fitness training and muscle strength exercise sessions at fixed times, >1 time/week
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Carina Boström
Stockholm, Huddinge, 141 83
Carina M Boström, Dr, 046 0722006321, carina.bostrom@ki.se
Ioannis Parodis, Dr, 046 0722321322, ioannis.parodis@ki.se
About this study
Official title: Effects of High-intensity Interval Training Combined With Resistance Training in Patients With Systemic Lupus Erythematosus
The aim of this study is to evaluate the safety and effects of high-intensity interval training (HIIT) combined with resistance training in patients with systemic lupus erythematosus
Read the detailed description
The overall aim of this randomized controlled study, is to evaluate the safety and effects of HIIT combined with resistance exercises on aerobic capacity, muscle function, patient reported outcomes, disease activity and immune function in patients with SLE with low to moderate disease activity and no to little organ damage. The aim is also to explore and describe patient's experiences of the training.
The research questions are:
- What are the differences between the HIIT combined with resistance exercises and a control group, after 3 months of supervised training and after further 3 months of self training with video-call/telephone support until 6 months follow up, regarding aerobic capacity, muscle function, physician and patient reported disease activity, fatigue, depressive symptoms, and quality of life?
- What are the differences between the HIIT combined with resistance exercises and a control group, after 3 months of supervised training and after further 3 months of self training with video-call/telephone support until 6 months follow up, regarding inflammatory markers such as interleukin 6 and 10 and interferon molecules? Both acute exercise test (maximal ergometercycle test) effects as well as the long term effects of training will be evaluated.
- How do individuals with SLE experience HIIT combined with resistance exercises ? What are the perceived barriers and facilitators for performing and maintaining such training?
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- HIIT combined with resistance training
- Keywords
- Physical exercise, High-intensity interval training, Resistance training, Quality of life, Aerobic capacity, Fatigue, Disease activity, Patients experiences, Inflammatory markers, Muscle function, Depressive symptoms
- Medical subject headings
- Lupus Erythematosus, Systemic, Motor Activity, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT combined with resistance trainingBehavioural
Patients with SLE will undergo supervised HIIT on an ergometercycle, 4 x 4 minutes interval, (85-90% of maximal heart rate in 4 minutes and lower intensity for another 4 minutes etc). The HIIT is combined with resistance exercises for upper and lower extremity. In total the training takes around 50 minutes per occasion and will be performed 2 times/week, for 3 months. In addition, the patients will exercise, according to the program, by themselves once a week.
Between months 3 and 6 the patients exercise by themselves, 3 times/week, with video-call/telephone support from a physiotherapist once a week.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training (HIIT) combined with resistance training | Experimental | Patients with SLE will undergo supervised HIIT on an ergometercycle 4 x 4 minutes interval (85-90% of maximal heart rate in 4 minutes and lower intensity for another 4 minutes etc). The HIIT is combined with resistance exercises for upper and lower extremity. In total the supervised training takes around 50 minutes per occasion and will be performed 2 times/week, for 3 months. In addition, the patients will exercise, according to the program, by themselves once a week.
Between months 3 and 6 the patients exercise by themselves, 3 times/week, with video-call/telephone support from a physiotherapist once a week. Receives: Behavioral: HIIT combined with resistance training |
| Control group | No intervention | Both the control group and the HIIT combined with resistance training group receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity
Aerobic capacity is measured as maximal oxygen uptake when performing a maximal symptom-limited, ergometercycle exercise test
Measured: Baseline, months 3 and 6
Physical capacity
Physical capacity are measured when performing a symptom-limited, ergometercycle exercise test
Measured: Baseline, months 3 and 6
Secondary outcomes (11)
Muscle function upper extremity
How many shoulder flexions (0-90 degrees), in a given pace, with a 3 kg (men) or 2 kg (women) dumbbell in the hand is possible to do
Measured: Baseline, months 3 and 6
Self-reported disease activity
The patient-reported questionnaire Systemic Lupus Erythematosus Activity Questionnaire includes three parts. The part about disease symptoms goes from 0-47 points, the higher the points the more disease symptoms. Further there is a question about flares with four answer alternatives, from no flares to serious flares. There is also a numerical rating scale about disease activity on a scale from 0-10, the higher value the higher the disease activity
Measured: Baseline, months 3 and 6
Fatigue
The patient-reported questionnaire Functional Assessment of Chronic Illness Therapy, FACIT-Fatigue goes from 0-52 points, the higher the value, the less the fatigue
Measured: Baseline, months 3 and 6
Anxiety and depressive symptoms
The patient-reported questionnaire Hospital Anxiety and Depression scale goes from 0-21 points, the higher the value, the higher the anxiety and depressive symptoms. In the anxiety and depressive symptoms subscales the points goes from 0-6, the higher the value, the higher anxiety and depressive symptoms respectively
Measured: Baseline, months 3 and 6
Quality of life in SLE
The patient-reported questionnaire Lupus Quality of life questionnaire goes from 0-100 points, the higher the value the better the quality of life
Measured: Baseline, months 3 and 6
Generic Quality of life
The patient-reported questionnaire Short Form Health Survey (SF-36). Each subscale goes from 0-100 points, the higher the value, the higher the quality of life.
Measured: Baseline, months 3 and 6
Quality of life and health status
The patient-reported questionnaire EuroQol 5-dimensions (EQ-5D). The index scores goes from -0,594 till 1,000, the higher the value, the higher the quality of life
Measured: Baseline, months 3 and 6
Disease activity
SLE Disease Activity Index 2000 (SLEDAI-2K) assessed by a physician, goes from 0-105 points, the higher the value, the higher the disease activity
Measured: Baseline, months 3 and 6
Inflammatory markers
Blood samples are collected before and after maximal ergometercycle exercise test
Measured: Baseline, months 3 and 6
Health status
The patient-reported questionnaire EuroQol 5-dimensions (EQ-5D)-5L Visual analogue scale, 0-100 mm, the higher the value, the better the health
Measured: Baseline, months 3 and 6
Blood pressure
Resting diastolic and systolic blood pressure
Measured: Baseline, month 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Nov 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- This is a randomised-controlled single blinded multicenter study. The trial will follow the Consolidated Standards of Reporting Trials, www.consort-statement.org and comprise two arms. After information of the study and written informed consent, the patients are block-randomised (from the aerobic capacity results) to either an intervention group doing supervised high-intensity interval training combined with resistance training or a control group. Both groups receive standard care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Rheumatism Association, Region Örebro County, County Council of Norrbotten, Sweden, Karolinska University Hospital
- Responsible party
- Principal investigator, Carina Boström, Karolinska Institutet
- Investigators
- Carina M Boström, Dr, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166199
- Sponsor's protocol ID
- 2021-05523-01
- Acronym
- SLE-HIIT
- Status last verified
- Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-intensity Interval Training Combined With Resistance Training in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06166199
- Acronym / sponsor ID
- SLE-HIIT / 2021-05523-01
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Physical exercise, High-intensity interval training, Resistance training, Quality of life, Aerobic capacity, Fatigue, Disease activity, Patients experiences
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Rheumatism Association, Region Örebro County, County Council of Norrbotten, Sweden, Karolinska University Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Dec 2023 (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.
The aim of this study is to evaluate the safety and effects of high-intensity interval training (HIIT) combined with resistance training in patients with systemic lupus erythematosus
Detailed description
The overall aim of this randomized controlled study, is to evaluate the safety and effects of HIIT combined with resistance exercises on aerobic capacity, muscle function, patient reported outcomes, disease activity and immune function in patients with SLE with low to moderate disease activity and no to little organ damage. The aim is also to explore and describe patient's experiences of the training.
The research questions are:
- What are the differences between the HIIT combined with resistance exercises and a control group, after 3 months of supervised training and after further 3 months of self training with video-call/telephone support until 6 months follow up, regarding aerobic capacity, muscle function, physician and patient reported disease activity, fatigue, depressive symptoms, and quality of life?
- What are the differences between the HIIT combined with resistance exercises and a control group, after 3 months of supervised training and after further 3 months of self training with video-call/telephone support until 6 months follow up, regarding inflammatory markers such as interleukin 6 and 10 and interferon molecules? Both acute exercise test (maximal ergometercycle test) effects as well as the long term effects of training will be evaluated.
- How do individuals with SLE experience HIIT combined with resistance exercises ? What are the perceived barriers and facilitators for performing and maintaining such training?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomised-controlled single blinded multicenter study. The trial will follow the Consolidated Standards of Reporting Trials, www.consort-statement.org and comprise two arms. After information of the study and written informed consent, the patients are block-randomised (from the aerobic capacity results) to either an intervention group doing supervised high-intensity interval training combined with resistance training or a control group. Both groups receive standard care.
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training (HIIT) combined with resistance training | Experimental | Behavioral: HIIT combined with resistance trainingPatients with SLE will undergo supervised HIIT on an ergometercycle 4 x 4 minutes interval (85-90% of maximal heart rate in 4 minutes and lower intensity for another 4 minutes etc). The HIIT is combined with resistance exercises for upper and lower extremity. In total the supervised training takes around 50 minutes per occasion and will be performed 2 times/week, for 3 months. In addition, the patients will exercise, according to the program, by themselves once a week. Between months 3 and 6 the patients exercise by themselves, 3 times/week, with video-call/telephone support from a physiotherapist once a week. |
| Control group | No intervention | –Both the control group and the HIIT combined with resistance training group receive standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years old
- Fulfilment of the 1982 American College of Rheumatology (ACR) criteria; or 2012 Systemic Lupus International Collaborating Clinics (SLICC/ACR-Damage Index (DI)) classification criteria; or EULAR/ACR criteria; or patients that have received the diagnosis SLE on clinical grounds
- Low to moderate disease activity, for example defined as a score of ≤5 in the clinical version of the SLE Disease Activity Index 2000 (SLEDAI-2K), i.e., excluding the serological descriptors (anti-dsDNA positivity and low complement levels)
- Low/minimal or no organ damage, for example defined as a score of ≤3 in the SLICC/ACR DI
- Stable pharmacological treatment
Key exclusion criteria (6 listed)
- Symptoms or signs of cerebro-vascular disease, pulmonary embolus, pulmonary hypertension, pulmonary fibrosis, cardiovascular disease, angina pectoris, myocardial infarction, dyspnea at rest, uncontrolled blood pressure and uncontrolled diabetes within one year prior to study entry. Chronic kidney disease with
- Patients who fulfil the absolute contraindications for maximal exercise testing according to American Heart Association
- Patients who cannot perform a maximal ergometercycle exercise test due to the disease
- Diseases or other conditions that strongly reduce the ability to exercise or that exercise is not recommended
- Patients who perform regular aerobic fitness training and muscle strength exercise sessions at fixed times, >1 time/week
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 |
|---|---|---|
| HIIT combined with resistance trainingPatients with SLE will undergo supervised HIIT on an ergometercycle, 4 x 4 minutes interval, (85-90% of maximal heart rate in 4 minutes and lower intensity for another 4 minutes etc). The HIIT is combined with resistance exercises for upper and lower extremity. In total the training takes around 50 minutes per occasion and will be performed 2 times/week, for 3 months. In addition, the patients will exercise, according to the program, by themselves once a week. Between months 3 and 6 the patients exercise by themselves, 3 times/week, with video-call/telephone support from a physiotherapist once a week. | Behavioural | High-intensity interval training (HIIT) combined with resistance training |
Primary outcome
Aerobic capacity
Time frame: Baseline, months 3 and 6
Aerobic capacity is measured as maximal oxygen uptake when performing a maximal symptom-limited, ergometercycle exercise test
Physical capacity
Time frame: Baseline, months 3 and 6
Physical capacity are measured when performing a symptom-limited, ergometercycle exercise test
11 secondary outcomes
Muscle function upper extremity
Time frame: Baseline, months 3 and 6
Self-reported disease activity
Time frame: Baseline, months 3 and 6
Fatigue
Time frame: Baseline, months 3 and 6
Anxiety and depressive symptoms
Time frame: Baseline, months 3 and 6
Quality of life in SLE
Time frame: Baseline, months 3 and 6
Generic Quality of life
Time frame: Baseline, months 3 and 6
Quality of life and health status
Time frame: Baseline, months 3 and 6
Disease activity
Time frame: Baseline, months 3 and 6
Inflammatory markers
Time frame: Baseline, months 3 and 6
Health status
Time frame: Baseline, months 3 and 6
Blood pressure
Time frame: Baseline, month 3 and 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Carina M Boström, Dr principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT combined with resistance training in people with Lupus Erythematosus, Systemic, run by Karolinska Institutet at 1 site in Sweden.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Dec 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carina M Boström, Dr (046 0722006321, carina.bostrom@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity (time frame: Baseline, months 3 and 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2023.