Physical Activity, Sedentary Behaviour and Cardiometabolic Health in Multiple Sclerosis

NCT ID: NCT05752630

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2024-01-20

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Bert Op't Eijnde

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bert Op 't Eijnde, prof.dr.

Role: STUDY_CHAIR

Hasselt University

Ine Nieste, drs.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

Hasselt University

Diepenbeek, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Bert Op 't Eijnde, prof. dr.

Role: CONTACT

bert.opteijnde@uhasselt.be

+32 11 29 21 21

Ine Nieste, drs.

Role: CONTACT

ine.nieste@uhasselt.be

+32496257499

Facility Contacts

Bert Op 't Eijnde, prof.dr.

Role: primary

bert.opteijnde@uhasselt.be

+3211292121

Ine Nieste, drs.

Role: backup

ine.nieste@uhasselt.be

+32496257499

Other Identifiers

CAMS

Identifier Type: -

Identifier Source: org_study_id