Multiple Sclerosis, Relapsing-RemittingNCT05752630
Physical Activity, Sedentary Behaviour and Cardiometabolic Health in Multiple Sclerosis
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Hasselt University at 1 site in Belgium.
Trial summary
This study evaluates the association between sedentary behaviour, physical activity, and the cardiometabolic health of Multiple Sclerosis via several cardiovascular, metabolic and anthropometric parameters. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jan 2023to 20 Jan 2024
- Phase
- Observational
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Persons with and without Multiple Sclerosis (MS), who also engage for more than 9h per day in sedentary behaviour. Healthy controls will be matched with persons with MS based on their physical activity level, gender, age and BMI.
Who may be able to join
- Relapse-remitting MS
- 25-60 years old
- EDSS < 5
- Sedentary behaviour (>9hours daily)
Who cannot join
- <9h SB/day,
- experienced an acute exacerbation within 6 months before the start of the study
- an expanded disability status scale (EDSS) score >5
- experimental drug use or medication changes in the last month
- medical conditions precluding PA participation
- alcohol abuse (>20 units/week)
Show all 11Show fewer
- reported dietary habits or weight loss (>2kg) in the last month before the study
- intention to start a new specific diet or start to follow an exercise intervention
- reported participation in another biomedical trial which may have an effect on blood parameters 1 month before the start of the study
- blood donation in the past month
- diagnosis of cardiometabolic diseases such as diabetes mellitus or heart and vascular diseases.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Diepenbeek, Limburg, 3590
Bert Op 't Eijnde, prof.dr., +3211292121, bert.opteijnde@uhasselt.be
Ine Nieste, drs., +32496257499, ine.nieste@uhasselt.be
About this study
Official title: The Relation Between Physical Activity, Sedentary Behaviour, and Cardiometabolic Health in Multiple Sclerosis
This study evaluates the association between sedentary behaviour, physical activity, and the cardiometabolic health of Multiple Sclerosis via several cardiovascular, metabolic and anthropometric parameters.
Read the detailed description
Multiple sclerosis (MS) is an autoimmune, inflammatory and neurodegenerative disorder of the central nervous system, predominantly affecting young to middle-aged adults. The disease manifests in a broad spectrum of associated sensory, motor and psychological dysfunction, and there is a large variability in symptoms between (and within) persons with MS (PwMS). This can (partly) be explained by the co-existence of cardiometabolic (CM) diseases, such as hypertension, dyslipidaemia, insulin resistance or diabetes. More specifically, the presence of one or more of these CM diseases has been associated with a worsening of disability, independent of the timing of their development (at MS symptom onset, diagnosis, or later in the disease course). Therefore, the prevention and/or treatment of these CM comorbidities also warrant attention in MS rehabilitation.
In most studies PwMS and HC were matched on age, sex, height and weight. Importantly, differences in physical activity (PA) and sedentary behaviour (SB) were never taken into account, while this might be a relevant matching risk factor between groups. Moreover, Ranadive et al. found a significant worse vascular function in PwMS compared to HC, but differences were accounted for by low PA in PwMS. This might mean that PwMS can completely attenuate their increased CM risk by increasing their PA. However, this conclusion was only based on a statistical correction, there was a large difference in PA between groups and other confounding factors (such as PA intensity, smoking and nutrition intake) were not taken into account.
Therefore, the present study aims to investigate the relation between CM health and different intensities of PA and SB in PA-matched PwMS and HC. When CM health is comparable between PwMS and HC with similar PA levels, this shows the importance of including PA and SB measures and interventions as early as possible in MS treatment before automatically starting CM medication because PwMS are known to have multiple risk factors.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Physical activity, Sedentary behaviour, Cardiometabolic health, Comorbidities
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Healthy controls who engage in sedentary behaviour for more than 9 hours per day. Strata will be used to ensure equal distribution of active and inactive participants (< and > 150min/MVPA/week) | |
| Persons with MS | Persons suffering from MS who engage in sedentary behaviour for more than 9 hours per day. Strata will be used to ensure equal distribution of active and inactive participants (< and > 150min/MVPA/week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1 kg
Measured: After 7 days of physical activity monitoring
Height
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
Measured: After 7 days of physical activity monitoring
DEXA (Dual Energy X-Ray)
body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
Measured: After 7 days of physical activity monitoring
Waist circumference
Waist circumference will be measured to the nearest 0.1cm using a flexible metric measuring tape with participants barefoot (in underwear) in standing position. Waist circumference is measured at the midpoint between the lower rib margin and the top of the iliac crest.
Measured: After 7 days of physical activity monitoring
Hip circumference
Hip circumference will be measured to the nearest 0.1cm using a flexible metric measuring tape with participants barefoot (in underwear) in standing position. Hip circumference is measured at the widest circumference of the hip at the level of the greater trochanter.
Measured: After 7 days of physical activity monitoring
Concentration of glucose
Concentration of glucose measured in blood analysis during OGTT
Measured: After 7 days of physical activity monitoring
Concentration of Insulin
Blood analysis of insulin during OGTT
Measured: After 7 days of physical activity monitoring
Concentration of total cholesterol
Blood analysis
Measured: After 7 days of physical activity monitoring
Concentration of high density lipoprotein cholesterol (HDL-cholesterol
Blood analysis
Measured: After 7 days of physical activity monitoring
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Blood analysis
Measured: After 7 days of physical activity monitoring
Concentration of triglyceride
Blood analysis
Measured: After 7 days of physical activity monitoring
Concentration of inflammatory markers
blood analysis of IL-6, TNF-α and C-reactive protein
Measured: After 7 days of physical activity monitoring
Reactive hyperaemia index (RHI)
Vascular endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device. The reactive hyperaemia index reflects the reactive hyperaemia response, and is calculated as the ratio of the average peripheral arterial tone (PAT) signal in the posthyperemic phase to the baseline PAT signal in the occluded arm, with normalization to the ratio of the PAT signal in the control arm to account for any systemic hemodynamic changes.
Measured: After 7 days of physical activity monitoring
Homeostatic model assessment for insulin resistance (HOMA-IR)
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the homeostatic model assessment for insulin resistance (HOMA-IR). The HOMA-IR is calculated from the fasting insulin and glucose concentration.sensitivity and beta cell function. The following parameters are calculated: homeostatic model assessment for insulin resistance, whole-body insulin sensitivity index, insulinogenic index and the area under the curve for glucose and insulin.
Measured: After 7 days of physical activity monitoring
Insulinogenic index
An oral glucose tolerance test will be performed for assessment of beta cell function by calculation of the insulinogenic index. The insulinogenic index is calculated from both insulin and glucose concentrations.
Measured: After 7 days of physical activity monitoring
Area under the curve of glucose and insulin concentrations
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of glucose and insulin concentrations
Measured: After 7 days of physical activity monitoring
Cardiac autonomic function
Cardiac autonomic function will be operationalized as heart rate variability by means of continuous beat-to-beat heart rate signal measurements. time domain and frequency domain analysis of the R-R intervals will be performed
Measured: After 7 days of physical activity monitoring
Systolic and Diastolic blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer
Measured: After 7 days of physical activity monitoring
metabolic syndrome (MetS) risk score
A continuous metabolic syndrome risk score will be calculated using the waist circumference, HDL concentration, systolic blood pressure, triglycerides and fasting glucose levels, as described by Gurka et al. (2014). A higher score indicates worse health. Because this is a continuous scale, there is no minimum and maximum value.
Measured: After 7 days of physical activity monitoring
Oxygen uptake (VO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VO2 is collected breath-by-breath and averaged every ten seconds.
Measured: After 7 days of physical activity monitoring
Respiratory gas exchange ratio (RER)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis RER is collected breath-by-breath and averaged every ten seconds.
Measured: After 7 days of physical activity monitoring
Heart rate (HR)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of a heart rate monitor the HR is measured and averaged every ten seconds.
Measured: After 7 days of physical activity monitoring
Arterial stiffness
Arterial stiffness will be determined by pulse wave analysis (PWA) and pulse wave velocity (PWV) using SphygmoCor (v9; Atcor Medical).
Measured: After 7 days of physical activity monitoring
Whole-body insulin sensitivity (WBISI)
(fasting) glucose and (fasting) insulin levels measured during blood analysis from OGTT are used to calculate whole body-insulin sensitivity.
Measured: After 7 days of physical activity monitoring
Secondary outcomes (12)
Steps per day
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: 7 days
Sitting time
Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: 7 days
Standing time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: 7 days
Walking time
Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Measured: 7 days
Sleeping time
Participants will have to keep track of their sleeping time by means of a sleep diary
Measured: 7 days
Exercise information
Participants will have to keep track of their exercise information by means of a diary
Measured: 7 days
Total calorie intake
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
Measured: 7 days
Macronutrient content
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Measured: 7 days
12-Item Multiple Sclerosis Walking Scale (MSWS-12) questionnaire
The MSWS-12 is a 12-item patient-rated measure of the impact of MS on walking over the past 2 weeks. The items are rated on a 5-point scale from 1 (Not at all) to 5 (Extremely).
Measured: After 7 days of physical activity monitoring
RAND-36 Item Health Survey (RAND-36) questionnaire
The RAND-36 (RAND refers to the American research organisation that developed the questionnaire; Research And Development') is a generic health profile that consists of two summary scales: a physical component summary (PCS) and a mental component summary (MCS). The total score is transformed to a hundred point scale. A higher score indicates a better health condition
Measured: After 7 days of physical activity monitoring
Modified fatigue impact scale (MFIS) questionnaire
The perceived impact of fatigue on physical, cognitive and psychosocial functioning of the past 4 weeks is assessed in the MFIS. A higher score indicates higher fatigue. The minimum and maximum value for the physical subscale is 0-36, for the cognitive subscale 0-40 and for the psychosocial subscale 0-8, resulting in a total score ranging from 0 to 84.
Measured: After 7 days of physical activity monitoring
Perceived stress scale (PSS) questionnaire
The PSS measures the level to which a respondent considers his or her life stressful and was designed to assess how unpredictable and controllable a person appraises his or her life. The PSS consists of 14 items ranging from 0 to 4. The total score is summed, a higher score indicates more stress.
Measured: After 7 days of physical activity monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start30 Jan 2023
- Primary completion20 Jan 2024 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
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 UniversityIne Nieste, drs., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752630
- Sponsor's protocol ID
- CAMS
- Status last verified
- Mar 2023
- First submitted
- 1 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Physical Activity, Sedentary Behaviour, and Cardiometabolic Health in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05752630
- Acronym / sponsor ID
- CAMS
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Physical activity, Sedentary behaviour, Cardiometabolic health, Comorbidities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 2 Mar 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.
This study evaluates the association between sedentary behaviour, physical activity, and the cardiometabolic health of Multiple Sclerosis via several cardiovascular, metabolic and anthropometric parameters.
Detailed description
Multiple sclerosis (MS) is an autoimmune, inflammatory and neurodegenerative disorder of the central nervous system, predominantly affecting young to middle-aged adults. The disease manifests in a broad spectrum of associated sensory, motor and psychological dysfunction, and there is a large variability in symptoms between (and within) persons with MS (PwMS). This can (partly) be explained by the co-existence of cardiometabolic (CM) diseases, such as hypertension, dyslipidaemia, insulin resistance or diabetes. More specifically, the presence of one or more of these CM diseases has been associated with a worsening of disability, independent of the timing of their development (at MS symptom onset, diagnosis, or later in the disease course). Therefore, the prevention and/or treatment of these CM comorbidities also warrant attention in MS rehabilitation.
In most studies PwMS and HC were matched on age, sex, height and weight. Importantly, differences in physical activity (PA) and sedentary behaviour (SB) were never taken into account, while this might be a relevant matching risk factor between groups. Moreover, Ranadive et al. found a significant worse vascular function in PwMS compared to HC, but differences were accounted for by low PA in PwMS. This might mean that PwMS can completely attenuate their increased CM risk by increasing their PA. However, this conclusion was only based on a statistical correction, there was a large difference in PA between groups and other confounding factors (such as PA intensity, smoking and nutrition intake) were not taken into account.
Therefore, the present study aims to investigate the relation between CM health and different intensities of PA and SB in PA-matched PwMS and HC. When CM health is comparable between PwMS and HC with similar PA levels, this shows the importance of including PA and SB measures and interventions as early as possible in MS treatment before automatically starting CM medication because PwMS are known to have multiple risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | –Healthy controls who engage in sedentary behaviour for more than 9 hours per day. Strata will be used to ensure equal distribution of active and inactive participants (< and > 150min/MVPA/week) |
| Persons with MS | – | –Persons suffering from MS who engage in sedentary behaviour for more than 9 hours per day. Strata will be used to ensure equal distribution of active and inactive participants (< and > 150min/MVPA/week) |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Persons with and without Multiple Sclerosis (MS), who also engage for more than 9h per day in sedentary behaviour. Healthy controls will be matched with persons with MS based on their physical activity level, gender, age and BMI.
Key inclusion criteria (4 listed)
- Relapse-remitting MS
- 25-60 years old
- EDSS < 5
- Sedentary behaviour (>9hours daily)
Key exclusion criteria (11 listed)
- <9h SB/day,
- experienced an acute exacerbation within 6 months before the start of the study
- an expanded disability status scale (EDSS) score >5
- experimental drug use or medication changes in the last month
- medical conditions precluding PA participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body weight
Time frame: After 7 days of physical activity monitoring
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1 kg
Height
Time frame: After 7 days of physical activity monitoring
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
DEXA (Dual Energy X-Ray)
Time frame: After 7 days of physical activity monitoring
body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
Waist circumference
Time frame: After 7 days of physical activity monitoring
Waist circumference will be measured to the nearest 0.1cm using a flexible metric measuring tape with participants barefoot (in underwear) in standing position. Waist circumference is measured at the midpoint between the lower rib margin and the top of the iliac crest.
Hip circumference
Time frame: After 7 days of physical activity monitoring
Hip circumference will be measured to the nearest 0.1cm using a flexible metric measuring tape with participants barefoot (in underwear) in standing position. Hip circumference is measured at the widest circumference of the hip at the level of the greater trochanter.
Concentration of glucose
Time frame: After 7 days of physical activity monitoring
Concentration of glucose measured in blood analysis during OGTT
Concentration of Insulin
Time frame: After 7 days of physical activity monitoring
Blood analysis of insulin during OGTT
Concentration of total cholesterol
Time frame: After 7 days of physical activity monitoring
Blood analysis
Concentration of high density lipoprotein cholesterol (HDL-cholesterol
Time frame: After 7 days of physical activity monitoring
Blood analysis
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Time frame: After 7 days of physical activity monitoring
Blood analysis
Concentration of triglyceride
Time frame: After 7 days of physical activity monitoring
Blood analysis
Concentration of inflammatory markers
Time frame: After 7 days of physical activity monitoring
blood analysis of IL-6, TNF-α and C-reactive protein
Reactive hyperaemia index (RHI)
Time frame: After 7 days of physical activity monitoring
Vascular endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device. The reactive hyperaemia index reflects the reactive hyperaemia response, and is calculated as the ratio of the average peripheral arterial tone (PAT) signal in the posthyperemic phase to the baseline PAT signal in the occluded arm, with normalization to the ratio of the PAT signal in the control arm to account for any systemic hemodynamic changes.
Homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: After 7 days of physical activity monitoring
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the homeostatic model assessment for insulin resistance (HOMA-IR). The HOMA-IR is calculated from the fasting insulin and glucose concentration.sensitivity and beta cell function. The following parameters are calculated: homeostatic model assessment for insulin resistance, whole-body insulin sensitivity index, insulinogenic index and the area under the curve for glucose and insulin.
Insulinogenic index
Time frame: After 7 days of physical activity monitoring
An oral glucose tolerance test will be performed for assessment of beta cell function by calculation of the insulinogenic index. The insulinogenic index is calculated from both insulin and glucose concentrations.
Area under the curve of glucose and insulin concentrations
Time frame: After 7 days of physical activity monitoring
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of glucose and insulin concentrations
Cardiac autonomic function
Time frame: After 7 days of physical activity monitoring
Cardiac autonomic function will be operationalized as heart rate variability by means of continuous beat-to-beat heart rate signal measurements. time domain and frequency domain analysis of the R-R intervals will be performed
Systolic and Diastolic blood pressure
Time frame: After 7 days of physical activity monitoring
Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer
metabolic syndrome (MetS) risk score
Time frame: After 7 days of physical activity monitoring
A continuous metabolic syndrome risk score will be calculated using the waist circumference, HDL concentration, systolic blood pressure, triglycerides and fasting glucose levels, as described by Gurka et al. (2014). A higher score indicates worse health. Because this is a continuous scale, there is no minimum and maximum value.
Oxygen uptake (VO2)
Time frame: After 7 days of physical activity monitoring
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VO2 is collected breath-by-breath and averaged every ten seconds.
Respiratory gas exchange ratio (RER)
Time frame: After 7 days of physical activity monitoring
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis RER is collected breath-by-breath and averaged every ten seconds.
Heart rate (HR)
Time frame: After 7 days of physical activity monitoring
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of a heart rate monitor the HR is measured and averaged every ten seconds.
Arterial stiffness
Time frame: After 7 days of physical activity monitoring
Arterial stiffness will be determined by pulse wave analysis (PWA) and pulse wave velocity (PWV) using SphygmoCor (v9; Atcor Medical).
Whole-body insulin sensitivity (WBISI)
Time frame: After 7 days of physical activity monitoring
(fasting) glucose and (fasting) insulin levels measured during blood analysis from OGTT are used to calculate whole body-insulin sensitivity.
12 secondary outcomes
Steps per day
Time frame: 7 days
Sitting time
Time frame: 7 days
Standing time
Time frame: 7 days
Walking time
Time frame: 7 days
Sleeping time
Time frame: 7 days
Exercise information
Time frame: 7 days
Total calorie intake
Time frame: 7 days
Macronutrient content
Time frame: 7 days
12-Item Multiple Sclerosis Walking Scale (MSWS-12) questionnaire
Time frame: After 7 days of physical activity monitoring
RAND-36 Item Health Survey (RAND-36) questionnaire
Time frame: After 7 days of physical activity monitoring
Modified fatigue impact scale (MFIS) questionnaire
Time frame: After 7 days of physical activity monitoring
Perceived stress scale (PSS) questionnaire
Time frame: After 7 days of physical activity monitoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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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.
Bert Op 't Eijnde, prof.dr. study chair
Hasselt University
Ine Nieste, drs. principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bert Op 't Eijnde, prof. dr. (+32 11 29 21 21, bert.opteijnde@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: After 7 days of physical activity monitoring). The study lists 24 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 2 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.