Multiple SclerosisNCT03919058
Sit Less or Exercise More: Impact on Cardiometabolic Health in MS
A study testing Increased sitting time (sit regime), Non-exercise physical activity (sit less regime) and Structured exercise (exercise regime) in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
Trial summary
This study evaluates the impact of reducing sitting time and increasing exercise time on cardiometabolic health in persons with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Increased sitting time (sit regime), Non-exercise physical activity (sit less regime) and Structured exercise (exercise regime)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Apr 2019to 30 Apr 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Men and women ≥18 years old
- Clinical diagnosis of MS (McDonald criteria)
- Expanded Disability Status Score ≤ 5
- Daily internet access
Who cannot join
- Reported participation in another biomedical trial which may have an effect on blood parameters one month before the pre-study examination or during the study
- Blood donation in the past three months
- Pregnancy or intention of becoming pregnant
- Reported dietary habits: medically prescribed diet, slimming diet
- Reported weight loss (>2kg) in the last three months prior to the screening
- Alcohol use > 20 units per week (during the last 3 months)
Show all 13Show fewer
- Experimental drug use (during the last 3 months)
- Medication changes (during the last month)
- Medical conditions which make participation in the study not responsible:
- Heart failure: New York Heart Association (NYHA) 3 or higher
- Angina pectoris or signs of cardiac ischemia during exercise testing
- Mental or physical disability
- Based on historical information not able to walk for 3h per day and stand for 4h per day (e.g. intermittent claudication)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sit Less or Exercise More: Impact on Cardiometabolic Health in Multiple Sclerosis
This study evaluates the impact of reducing sitting time and increasing exercise time on cardiometabolic health in persons with Multiple Sclerosis.
Read the detailed description
To date, it is clear that sedentary behaviour is strongly related to an increased risk of type II diabetes, cardiovascular disease and premature mortality. People suffering from chronic disabilities appear to be particularly susceptible to a sedentary lifestyle and inactivity due to primary disease symptoms. To date, this is an important new research topic in Multiple Sclerosis (MS, ~2.3 million people worldwide, ~10-12.000 diagnosed in Belgium) treatment, since previous research reported a significantly higher prevalence of sedentary behaviour in persons with MS (PwMS) compared to healthy controls (HC). PwMS are reported to have a 40% lower daily step count compared to healthy inactive persons and tend to accumulate their sedentary time in longer bouts. As described above and similar to other chronic conditions, a sedentary lifestyle also makes PwMS more vulnerable to the accumulation of important cardiometabolic comorbidities that seem inactivity-related rather than a direct result of non-reversible tissue injury. Such comorbidities include impaired whole body glycaemic control, an abnormal blood lipid profile, an unhealthy body composition and hypertension. In this respect, it is important to note that corticosteroids, which are often used to treat MS patients pharmacologically, elevate fasting glucose and insulin concentrations and induce insulin resistance in HC therefore probably also increase several cardiometabolic risk factors in MS.
Up to now, research in MS has been focused on structured exercise and its positive effects on functional parameters are well-known (e.g. improvements in cardiorespiratory fitness, muscle strength, balance, fatigue, cognition, quality of life and respiratory function). However, evidence is growing that sedentary time, independent of the (dis)practice of structured exercise, is an important independent health risk factor. Consequently, any strategy that also improves cardiometabolic health may help to further optimize rehabilitation in MS. Breaking up and reducing sedentary time with easy, daily activities such as household activities and other activities which increase light-intensity walking and standing, known as non-exercise physical activity (NEPA) may be such a strategy.
NEPA has already been shown to significantly improve cardiometabolic risk markers in healthy, sedentary subjects, type II diabetes patients and obese adults and it involves lower intensity physical activities that are probably more feasible for PwMS. Moreover, with comparable activity workloads, reducing sitting time by NEPA of longer duration decreases insulin levels and fasting lipid levels more than performing one structured exercise bout of moderate intensity that is usually described in current activity guidelines. So far however, acute exercise bouts and NEPA effects on cardiometabolic health in this population have never been described. Therefore, the aim of this study is to investigate whether (1) cardiometabolic health (glycaemic control, blood lipids, inflammation markers and blood pressure) of persons with MS improves when sedentary time is reduced and (2) NEPA results in better cardiometabolic health parameters than (a shorter daily bout of) moderate-intensity exercise when workload of both activities is identical in this population.
- Conditions
- Multiple Sclerosis
- Being tested
- Baseline activity (control regime), Increased sitting time (sit regime), Non-exercise physical activity (sit less regime), Structured exercise (exercise regime)
- Keywords
- Multiple Sclerosis, Non-exercise physical activity, NEPA, Cardiometabolic health, Comorbidities
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline activity (control regime)Other
This is a baseline measurement of physical activity during which subjects will be instructed not to change activity patterns during four days and to note all activities they perform.
Increased sitting time (sit regime)Other
Participants have to spend 14h of their day sitting, 1h walking and 1h standing, for four consecutive days. According to the compendium of Ainsworth et al. (2011), this corresponds with a daily workload of activities (DWA) of 27 metabolic equivalents (MET's) per day.
Non-exercise physical activity (sit less regime)Other
Each day (4 days in total) will consist of 3h walking, 4h standing and 9h sitting. These time frames are chosen to result in a comparable DWA increase as the exercise regime compared to the sit regime (+7 MET's)27. The additional 2h of walking and 3h of standing, compared to the sitting regime, will be done in a minimum of four bouts with a time interval of > 1h. The subjects will be instructed to walk on a slow pace. i.e. 2-3 km/h (e.g. walking during shopping and work related walking in an office).
Structured exercise (exercise regime)Other
One hour of sitting in the sit regime will be replaced with 1 training session (1h) on a cycle ergometer in the research center. The remaining hours of each day (4 days in total) have to be spent as follows: 13h sitting, 1h walking and 1h standing for daily care. The intensity of the training session (50-60% of Wmax) results in a DWA of 34.5 MET's according to the compendium of physical activities. Duration of training sessions will be adapted individually with ActivPAL data of the sit less and sit regime to identically match DWA increase between the sit less and exercise regime, compared to the sitting regime.
| Study group | Role | What they receive |
|---|---|---|
| Regime 1: control regime | Active comparator | All participants start with the control regime, where baseline activity will be measured. Receives: Other: Baseline activity (control regime) |
| Regime 2: Sit regime/sit less regime | Experimental | The order of the regimes will be randomized, half of the participants will execute the sit regime as second regime, the other half will execute the sit less regime as second regime. Subjects have to follow a pre-defined activity protocol and receive an activity tracker (Polar M200) in order to self-monitor their activity. Receives: Other: Increased sitting time (sit regime); Other: Non-exercise physical activity (sit less regime) |
| Regime 3: Sit less regime/sit regime | Experimental | The order of the regimes will be randomized, half of the participants will execute the sit regime as second regime, the other half will execute the sit less regime as second regime. Subjects have to follow a pre-defined activity protocol and receive an activity tracker (Polar M200) in order to self-monitor their activity. Receives: Other: Increased sitting time (sit regime); Other: Non-exercise physical activity (sit less regime) |
| Regime 4: Exercise regime | Experimental | The exercise regime is the final regime for all participants. This is comparable with the sit regime, but 1h of sitting is replaced with 1 exercise bout. Receives: Other: Structured exercise (exercise regime) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps per day
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the control regime
Sitting time
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the control regime
Standing time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the control regime
Stepping time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the control regime
Concentration of glucose
Blood analysis
Measured: Day after the control regime
Concentration of insulin
Blood analysis
Measured: Day after the control regime
Concentration of total cholesterol
Blood analysis
Measured: Day after the control regime
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Blood analysis
Measured: Day after the control regime
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Blood analysis
Measured: Day after the control regime
Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
Blood analysis
Measured: Day after the control regime
Concentration of triglyceride
Blood analysis
Measured: Day after the control regime
Concentration of apolipoprotein A1 (apo A1)
Blood analysis
Measured: Day after the control regime
Concentration of apolipoprotein B (apo B)
Blood analysis
Measured: Day after the control regime
Concentration of free fatty acids (FFA)
Blood analysis
Measured: Day after the control regime
Concentration of C-reactive protein (CRP)
Blood analysis
Measured: Day after the control regime
Concentration of interleukin 1 (IL-1)
Blood analysis
Measured: Day after the control regime
Concentration of interleukin 6 (IL-6)
Blood analysis
Measured: Day after the control regime
Steps per day
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Sit regime
Sitting time
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Dag 1 to 4 of the Sit regime
Standing time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Sit regime
Stepping time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Sit regime
Concentration of glucose
Blood analysis
Measured: Day after the Sit regime
Concentration of insulin
Blood analysis
Measured: Day after the Sit regime
Concentration of total cholesterol
Blood analysis
Measured: Day after the Sit regime
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Blood analysis
Measured: Day after the Sit regime
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Blood analysis
Measured: Day after the Sit regime
Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
Blood analysis
Measured: Day after the Sit regime
Concentration of triglyceride
Blood analysis
Measured: Day after the Sit regime
Concentration of apolipoprotein A1 (apo A1)
Blood analysis
Measured: Day after the Sit regime
Concentration of apolipoprotein B (apo B)
Blood analysis
Measured: Day after the Sit regime
Concentration of free fatty acids (FFA)
Blood analysis
Measured: Day after the Sit regime
Concentration of C-reactive protein (CRP)
Blood analysis
Measured: Day after the Sit regime
Concentration of interleukin 1 (IL-1)
Blood analysis
Measured: Day after the Sit regime
Concentration of interleukin 6 (IL-6)
Blood analysis
Measured: Day after the Sit regime
Steps per day
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Sit Less regime
Sitting time
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Sit Less regime
Standing time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Sit Less regime
Stepping time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Sit Less regime
Concentration of glucose
Blood analysis
Measured: Day after the Sit Less regime
Concentration of insulin
Blood analysis
Measured: Day after the Sit Less regime
Concentration of total cholesterol
Blood analysis
Measured: Day after the Sit Less regime
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Blood analysis
Measured: Day after the Sit Less regime
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Blood analysis
Measured: Day after the Sit Less regime
Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
Blood analysis
Measured: Day after the Sit Less regime
Concentration of triglyceride
Blood analysis
Measured: Day after the Sit Less regime
Concentration of apolipoprotein A1 (apo A1)
Blood analysis
Measured: Day after the Sit Less regime
Concentration of apolipoprotein B (apo B)
Blood analysis
Measured: Day after the Sit Less regime
Concentration of free fatty acids (FFA)
Blood analysis
Measured: Day after the Sit Less regime
Concentration of C-reactive protein (CRP)
Blood analysis
Measured: Day after the Sit Less regime
Concentration of interleukin 1 (IL-1)
Blood analysis
Measured: Day after the Sit Less regime
Concentration of interleukin 6 (IL-6)
Blood analysis
Measured: Day after the Sit Less regime
Steps per day
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Exercise regime
Sitting time
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Exercise regime
Standing time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Exercise regime
Stepping time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: Day 1 to 4 of the Exercise regime
Concentration of glucose
Blood analysis
Measured: Day after the Exercise regime
Concentration of insulin
Blood analysis
Measured: Day after the Exercise regime
Concentration of total cholesterol
Blood analysis
Measured: Day after the Exercise regime
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Blood analysis
Measured: Day after the Exercise regime
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Blood analysis
Measured: Day after the Exercise regime
Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
Blood analysis
Measured: Day after the Exercise regime
Concentration of triglyceride
Blood analysis
Measured: Day after the Exercise regime
Concentration of apolipoprotein A1 (apo A1)
Blood analysis
Measured: Day after the Exercise regime
Concentration of apolipoprotein B (apo B)
Blood analysis
Measured: Day after the Exercise regime
Concentration of free fatty acids (FFA)
Blood analysis
Measured: Day after the Exercise regime
Concentration of C-reactive protein (CRP)
Blood analysis
Measured: Day after the Exercise regime
Concentration of interleukin 1 (IL-1)
Blood analysis
Measured: Day after the Exercise regime
Concentration of interleukin 6 (IL-6)
Blood analysis
Measured: Day after the Exercise regime
Secondary outcomes (8)
Blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer (Omron®, Omron Healthcare, IL, USA) from the dominant arm and documented as the mean value of the final 2 measurements.
Measured: Day after the Control regime
Body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Measured: Day after the Control regime
Blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer (Omron®, Omron Healthcare, IL, USA) from the dominant arm and documented as the mean value of the final 2 measurements.
Measured: Day after the Sit regime
Body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Measured: Day after the Sit regime
Blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer (Omron®, Omron Healthcare, IL, USA) from the dominant arm and documented as the mean value of the final 2 measurements.
Measured: Day after the Sit Less regime
Body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Measured: Day after the Sit Less regime
Blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer (Omron®, Omron Healthcare, IL, USA) from the dominant arm and documented as the mean value of the final 2 measurements.
Measured: Day after the Exercise regime
Body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Measured: Day after the Exercise regime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start13 Apr 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will follow four regimes of 4 days each including a control, a sit less, a sit and an exercise regime. The order of the sit and sit less regimes will be randomized. Each activity regime will be followed by a wash-out period of 10 days during which subjects will continue their normal lifestyle.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bert Op't Eijnde, Hasselt University
- Investigators
- Bert Op 't Eijnde, Prof. dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919058
- Sponsor's protocol ID
- RST-MS
- Status last verified
- Aug 2021
- First submitted
- 12 Apr 2019
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nieste I, Franssen WMA, Duvivier BMFM, Spaas J, Savelberg HHCM, Eijnde BO. Replacing sitting with light-intensity physical activity throughout the day versus 1 bout of vigorous-intensity exercise: similar cardiometabolic health effects in multiple sclerosis. A randomised cross-over study. Disabil Rehabil. 2023 Oct;45(20):3293-3302. doi: 10.1080/09638288.2022.2122601. Epub 2022 Oct 3.
PubMed 36190113
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sit Less or Exercise More: Impact on Cardiometabolic Health in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03919058
- Acronym / sponsor ID
- RST-MS
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Non-exercise physical activity, NEPA, Cardiometabolic health, Comorbidities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 18 Apr 2019 (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.
This study evaluates the impact of reducing sitting time and increasing exercise time on cardiometabolic health in persons with Multiple Sclerosis.
Detailed description
To date, it is clear that sedentary behaviour is strongly related to an increased risk of type II diabetes, cardiovascular disease and premature mortality. People suffering from chronic disabilities appear to be particularly susceptible to a sedentary lifestyle and inactivity due to primary disease symptoms. To date, this is an important new research topic in Multiple Sclerosis (MS, ~2.3 million people worldwide, ~10-12.000 diagnosed in Belgium) treatment, since previous research reported a significantly higher prevalence of sedentary behaviour in persons with MS (PwMS) compared to healthy controls (HC). PwMS are reported to have a 40% lower daily step count compared to healthy inactive persons and tend to accumulate their sedentary time in longer bouts. As described above and similar to other chronic conditions, a sedentary lifestyle also makes PwMS more vulnerable to the accumulation of important cardiometabolic comorbidities that seem inactivity-related rather than a direct result of non-reversible tissue injury. Such comorbidities include impaired whole body glycaemic control, an abnormal blood lipid profile, an unhealthy body composition and hypertension. In this respect, it is important to note that corticosteroids, which are often used to treat MS patients pharmacologically, elevate fasting glucose and insulin concentrations and induce insulin resistance in HC therefore probably also increase several cardiometabolic risk factors in MS.
Up to now, research in MS has been focused on structured exercise and its positive effects on functional parameters are well-known (e.g. improvements in cardiorespiratory fitness, muscle strength, balance, fatigue, cognition, quality of life and respiratory function). However, evidence is growing that sedentary time, independent of the (dis)practice of structured exercise, is an important independent health risk factor. Consequently, any strategy that also improves cardiometabolic health may help to further optimize rehabilitation in MS. Breaking up and reducing sedentary time with easy, daily activities such as household activities and other activities which increase light-intensity walking and standing, known as non-exercise physical activity (NEPA) may be such a strategy.
NEPA has already been shown to significantly improve cardiometabolic risk markers in healthy, sedentary subjects, type II diabetes patients and obese adults and it involves lower intensity physical activities that are probably more feasible for PwMS. Moreover, with comparable activity workloads, reducing sitting time by NEPA of longer duration decreases insulin levels and fasting lipid levels more than performing one structured exercise bout of moderate intensity that is usually described in current activity guidelines. So far however, acute exercise bouts and NEPA effects on cardiometabolic health in this population have never been described. Therefore, the aim of this study is to investigate whether (1) cardiometabolic health (glycaemic control, blood lipids, inflammation markers and blood pressure) of persons with MS improves when sedentary time is reduced and (2) NEPA results in better cardiometabolic health parameters than (a shorter daily bout of) moderate-intensity exercise when workload of both activities is identical in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will follow four regimes of 4 days each including a control, a sit less, a sit and an exercise regime. The order of the sit and sit less regimes will be randomized. Each activity regime will be followed by a wash-out period of 10 days during which subjects will continue their normal lifestyle.
| Arm | Type | Receives |
|---|---|---|
| Regime 1: control regime | Active comparator | Other: Baseline activity (control regime)All participants start with the control regime, where baseline activity will be measured. |
| Regime 2: Sit regime/sit less regime | Experimental | Other: Increased sitting time (sit regime), Other: Non-exercise physical activity (sit less regime)The order of the regimes will be randomized, half of the participants will execute the sit regime as second regime, the other half will execute the sit less regime as second regime. Subjects have to follow a pre-defined activity protocol and receive an activity tracker (Polar M200) in order to self-monitor their activity. |
| Regime 3: Sit less regime/sit regime | Experimental | Other: Increased sitting time (sit regime), Other: Non-exercise physical activity (sit less regime)The order of the regimes will be randomized, half of the participants will execute the sit regime as second regime, the other half will execute the sit less regime as second regime. Subjects have to follow a pre-defined activity protocol and receive an activity tracker (Polar M200) in order to self-monitor their activity. |
| Regime 4: Exercise regime | Experimental | Other: Structured exercise (exercise regime)The exercise regime is the final regime for all participants. This is comparable with the sit regime, but 1h of sitting is replaced with 1 exercise bout. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Men and women ≥18 years old
- Clinical diagnosis of MS (McDonald criteria)
- Expanded Disability Status Score ≤ 5
- Daily internet access
Key exclusion criteria (13 listed)
- Reported participation in another biomedical trial which may have an effect on blood parameters one month before the pre-study examination or during the study
- Blood donation in the past three months
- Pregnancy or intention of becoming pregnant
- Reported dietary habits: medically prescribed diet, slimming diet
- Reported weight loss (>2kg) in the last three months prior to the screening
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 |
|---|---|---|
| Baseline activity (control regime)This is a baseline measurement of physical activity during which subjects will be instructed not to change activity patterns during four days and to note all activities they perform. | Other | Regime 1: control regime |
| Increased sitting time (sit regime)Participants have to spend 14h of their day sitting, 1h walking and 1h standing, for four consecutive days. According to the compendium of Ainsworth et al. (2011), this corresponds with a daily workload of activities (DWA) of 27 metabolic equivalents (MET's) per day. | Other | Regime 2: Sit regime/sit less regime, Regime 3: Sit less regime/sit regime |
| Non-exercise physical activity (sit less regime)Each day (4 days in total) will consist of 3h walking, 4h standing and 9h sitting. These time frames are chosen to result in a comparable DWA increase as the exercise regime compared to the sit regime (+7 MET's)27. The additional 2h of walking and 3h of standing, compared to the sitting regime, will be done in a minimum of four bouts with a time interval of > 1h. The subjects will be instructed to walk on a slow pace. i.e. 2-3 km/h (e.g. walking during shopping and work related walking in an office). | Other | Regime 2: Sit regime/sit less regime, Regime 3: Sit less regime/sit regime |
| Structured exercise (exercise regime)One hour of sitting in the sit regime will be replaced with 1 training session (1h) on a cycle ergometer in the research center. The remaining hours of each day (4 days in total) have to be spent as follows: 13h sitting, 1h walking and 1h standing for daily care. The intensity of the training session (50-60% of Wmax) results in a DWA of 34.5 MET's according to the compendium of physical activities. Duration of training sessions will be adapted individually with ActivPAL data of the sit less and sit regime to identically match DWA increase between the sit less and exercise regime, compared to the sitting regime. | Other | Regime 4: Exercise regime |
Primary outcome
Steps per day
Time frame: Day 1 to 4 of the control regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Sitting time
Time frame: Day 1 to 4 of the control regime
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Standing time
Time frame: Day 1 to 4 of the control regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Stepping time
Time frame: Day 1 to 4 of the control regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Concentration of glucose
Time frame: Day after the control regime
Blood analysis
Concentration of insulin
Time frame: Day after the control regime
Blood analysis
Concentration of total cholesterol
Time frame: Day after the control regime
Blood analysis
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Time frame: Day after the control regime
Blood analysis
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Time frame: Day after the control regime
Blood analysis
Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
Time frame: Day after the control regime
Blood analysis
Concentration of triglyceride
Time frame: Day after the control regime
Blood analysis
Concentration of apolipoprotein A1 (apo A1)
Time frame: Day after the control regime
Blood analysis
Concentration of apolipoprotein B (apo B)
Time frame: Day after the control regime
Blood analysis
Concentration of free fatty acids (FFA)
Time frame: Day after the control regime
Blood analysis
Concentration of C-reactive protein (CRP)
Time frame: Day after the control regime
Blood analysis
Concentration of interleukin 1 (IL-1)
Time frame: Day after the control regime
Blood analysis
Concentration of interleukin 6 (IL-6)
Time frame: Day after the control regime
Blood analysis
Steps per day
Time frame: Day 1 to 4 of the Sit regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Sitting time
Time frame: Dag 1 to 4 of the Sit regime
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Standing time
Time frame: Day 1 to 4 of the Sit regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Stepping time
Time frame: Day 1 to 4 of the Sit regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Concentration of glucose
Time frame: Day after the Sit regime
Blood analysis
Concentration of insulin
Time frame: Day after the Sit regime
Blood analysis
Concentration of total cholesterol
Time frame: Day after the Sit regime
Blood analysis
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Time frame: Day after the Sit regime
Blood analysis
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Time frame: Day after the Sit regime
Blood analysis
Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
Time frame: Day after the Sit regime
Blood analysis
Concentration of triglyceride
Time frame: Day after the Sit regime
Blood analysis
Concentration of apolipoprotein A1 (apo A1)
Time frame: Day after the Sit regime
Blood analysis
Concentration of apolipoprotein B (apo B)
Time frame: Day after the Sit regime
Blood analysis
Concentration of free fatty acids (FFA)
Time frame: Day after the Sit regime
Blood analysis
Concentration of C-reactive protein (CRP)
Time frame: Day after the Sit regime
Blood analysis
Concentration of interleukin 1 (IL-1)
Time frame: Day after the Sit regime
Blood analysis
Concentration of interleukin 6 (IL-6)
Time frame: Day after the Sit regime
Blood analysis
Steps per day
Time frame: Day 1 to 4 of the Sit Less regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Sitting time
Time frame: Day 1 to 4 of the Sit Less regime
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Standing time
Time frame: Day 1 to 4 of the Sit Less regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Stepping time
Time frame: Day 1 to 4 of the Sit Less regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Concentration of glucose
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of insulin
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of total cholesterol
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of triglyceride
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of apolipoprotein A1 (apo A1)
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of apolipoprotein B (apo B)
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of free fatty acids (FFA)
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of C-reactive protein (CRP)
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of interleukin 1 (IL-1)
Time frame: Day after the Sit Less regime
Blood analysis
Concentration of interleukin 6 (IL-6)
Time frame: Day after the Sit Less regime
Blood analysis
Steps per day
Time frame: Day 1 to 4 of the Exercise regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Sitting time
Time frame: Day 1 to 4 of the Exercise regime
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Standing time
Time frame: Day 1 to 4 of the Exercise regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Stepping time
Time frame: Day 1 to 4 of the Exercise regime
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Concentration of glucose
Time frame: Day after the Exercise regime
Blood analysis
Concentration of insulin
Time frame: Day after the Exercise regime
Blood analysis
Concentration of total cholesterol
Time frame: Day after the Exercise regime
Blood analysis
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Time frame: Day after the Exercise regime
Blood analysis
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Time frame: Day after the Exercise regime
Blood analysis
Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
Time frame: Day after the Exercise regime
Blood analysis
Concentration of triglyceride
Time frame: Day after the Exercise regime
Blood analysis
Concentration of apolipoprotein A1 (apo A1)
Time frame: Day after the Exercise regime
Blood analysis
Concentration of apolipoprotein B (apo B)
Time frame: Day after the Exercise regime
Blood analysis
Concentration of free fatty acids (FFA)
Time frame: Day after the Exercise regime
Blood analysis
Concentration of C-reactive protein (CRP)
Time frame: Day after the Exercise regime
Blood analysis
Concentration of interleukin 1 (IL-1)
Time frame: Day after the Exercise regime
Blood analysis
Concentration of interleukin 6 (IL-6)
Time frame: Day after the Exercise regime
Blood analysis
8 secondary outcomes
Blood pressure
Time frame: Day after the Control regime
Body weight
Time frame: Day after the Control regime
Blood pressure
Time frame: Day after the Sit regime
Body weight
Time frame: Day after the Sit regime
Blood pressure
Time frame: Day after the Sit Less regime
Body weight
Time frame: Day after the Sit Less regime
Blood pressure
Time frame: Day after the Exercise regime
Body weight
Time frame: Day after the Exercise regime
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 31 Aug 2021.
- Derived from this study: PubMed 36190113Nieste I, Franssen WMA, Duvivier BMFM, Spaas J, Savelberg HHCM, Eijnde BO. Replacing sitting with light-intensity physical activity throughout the day versus 1 bout of vigorous-intensity exercise: similar cardiometabolic health effects in multiple sclerosis. A randomised cross-over study. Disabil Rehabil. 2023 Oct;45(20):3293-3302. doi: 10.1080/09638288.2022.2122601. Epub 2022 Oct 3.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Bert Op 't Eijnde, Prof. dr. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased sitting time (sit regime), Non-exercise physical activity (sit less regime) and Structured exercise (exercise regime) in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
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 13 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 31 Aug 2021. 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 Belgium. 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?
Steps per day (time frame: Day 1 to 4 of the control regime). The study lists 68 primary outcomes in all. 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 NCT03919058, which also lists 1 linked publication.
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 31 Aug 2021.