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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Physical Activity, Sedentary Behaviour and Cardiometabolic Health in Multiple Sclerosis

Study Purpose

This study evaluates the association between sedentary behaviour, physical activity, and the cardiometabolic health of Multiple Sclerosis via several cardiovascular, metabolic and anthropometric parameters.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 25 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Relapse-remitting MS.
  • - 25-60 years old.
  • - EDSS < 5.
  • - Sedentary behaviour (>9hours daily)

    Exclusion Criteria:

    - <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) - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05752630
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hasselt University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bert Op 't Eijnde, prof.dr.Ine Nieste, drs.
Principal Investigator Affiliation Hasselt UniversityHasselt University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis, Relapsing-Remitting
Additional Details

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.

Arms & Interventions

Arms

: 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)

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hasselt University, Diepenbeek, Limburg, Belgium

Status

Recruiting

Address

Hasselt University

Diepenbeek, Limburg, 3590

Site Contact

Bert Op 't Eijnde, prof.dr.

[email protected]

+3211292121

Nearest Location

Site Contact

Bert Op 't Eijnde, prof.dr.

[email protected]

+3211292121


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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