Clinical trial NCT05752630: Physical Activity, Sedentary Behaviour and Cardiometabolic Health in Multiple Sclerosis
Official title: The Relation Between Physical Activity, Sedentary Behaviour, and Cardiometabolic Health in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Physical activity
Sedentary behaviour
Cardiometabolic health
Comorbidities
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

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.

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.

Primary outcomes:
measure: Body weight
timeFrame: After 7 days of physical activity monitoring
measure: Height
timeFrame: After 7 days of physical activity monitoring
measure: DEXA (Dual Energy X-Ray)
timeFrame: After 7 days of physical activity monitoring
measure: Waist circumference
timeFrame: After 7 days of physical activity monitoring
measure: Hip circumference
timeFrame: After 7 days of physical activity monitoring
measure: Concentration of glucose
timeFrame: After 7 days of physical activity monitoring
measure: Concentration of Insulin
timeFrame: After 7 days of physical activity monitoring
measure: Concentration of total cholesterol
timeFrame: After 7 days of physical activity monitoring
measure: Concentration of high density lipoprotein cholesterol (HDL-cholesterol
timeFrame: After 7 days of physical activity monitoring
measure: Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
timeFrame: After 7 days of physical activity monitoring
measure: Concentration of triglyceride
timeFrame: After 7 days of physical activity monitoring
measure: Concentration of inflammatory markers
timeFrame: After 7 days of physical activity monitoring
measure: Reactive hyperaemia index (RHI)
timeFrame: After 7 days of physical activity monitoring
measure: Homeostatic model assessment for insulin resistance (HOMA-IR)
timeFrame: After 7 days of physical activity monitoring
measure: Insulinogenic index
timeFrame: After 7 days of physical activity monitoring
measure: Area under the curve of glucose and insulin concentrations
timeFrame: After 7 days of physical activity monitoring
measure: Cardiac autonomic function
timeFrame: After 7 days of physical activity monitoring
measure: Systolic and Diastolic blood pressure
timeFrame: After 7 days of physical activity monitoring
measure: metabolic syndrome (MetS) risk score
timeFrame: After 7 days of physical activity monitoring
measure: Oxygen uptake (VO2)
timeFrame: After 7 days of physical activity monitoring
measure: Respiratory gas exchange ratio (RER)
timeFrame: After 7 days of physical activity monitoring
measure: Heart rate (HR)
timeFrame: After 7 days of physical activity monitoring
measure: Arterial stiffness
timeFrame: After 7 days of physical activity monitoring
measure: Whole-body insulin sensitivity (WBISI)
timeFrame: After 7 days of physical activity monitoring
Secondary outcomes:
measure: Steps per day
timeFrame: 7 days
measure: Sitting time
timeFrame: 7 days
measure: Standing time
timeFrame: 7 days
measure: Walking time
timeFrame: 7 days
measure: Sleeping time
timeFrame: 7 days
measure: Exercise information
timeFrame: 7 days
measure: Total calorie intake
timeFrame: 7 days
measure: Macronutrient content
timeFrame: 7 days
measure: 12-Item Multiple Sclerosis Walking Scale (MSWS-12) questionnaire
timeFrame: After 7 days of physical activity monitoring
measure: RAND-36 Item Health Survey (RAND-36) questionnaire
timeFrame: After 7 days of physical activity monitoring
measure: Modified fatigue impact scale (MFIS) questionnaire
timeFrame: After 7 days of physical activity monitoring
measure: Perceived stress scale (PSS) questionnaire
timeFrame: After 7 days of physical activity monitoring
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: Hasselt University
name: Bert Op 't Eijnde, prof.dr.
role: STUDY_CHAIR
affiliation: Hasselt University
name: Ine Nieste, drs.
role: PRINCIPAL_INVESTIGATOR
References: