Physical Activity, Sedentary Behaviour and Cardiometabolic Health in Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

The Relation Between Physical Activity, Sedentary Behaviour, and Cardiometabolic Health in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752630
• Other study ID #: CAMS
• Status: Recruiting
• Start date: January 30, 2023
• Est. completion date: January 20, 2024

Study information

• Verified date: March 2023
• Source: Hasselt University
• Contact: Bert Op 't Eijnde, prof. dr.
• Phone: +32 11 29 21 21
• Email: bert.opteijnde[@]uhasselt.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1 kg	After 7 days of physical activity monitoring
Primary	Height	Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot	After 7 days of physical activity monitoring
Primary	DEXA (Dual Energy X-Ray)	body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry	After 7 days of physical activity monitoring
Primary	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.	After 7 days of physical activity monitoring
Primary	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.	After 7 days of physical activity monitoring
Primary	Concentration of glucose	Concentration of glucose measured in blood analysis during OGTT	After 7 days of physical activity monitoring
Primary	Concentration of Insulin	Blood analysis of insulin during OGTT	After 7 days of physical activity monitoring
Primary	Concentration of total cholesterol	Blood analysis	After 7 days of physical activity monitoring
Primary	Concentration of high density lipoprotein cholesterol (HDL-cholesterol	Blood analysis	After 7 days of physical activity monitoring
Primary	Concentration of low density lipoprotein cholesterol (LDL-cholesterol)	Blood analysis	After 7 days of physical activity monitoring
Primary	Concentration of triglyceride	Blood analysis	After 7 days of physical activity monitoring
Primary	Concentration of inflammatory markers	blood analysis of IL-6, TNF-a and C-reactive protein	After 7 days of physical activity monitoring
Primary	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.	After 7 days of physical activity monitoring
Primary	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.	After 7 days of physical activity monitoring
Primary	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.	After 7 days of physical activity monitoring
Primary	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	After 7 days of physical activity monitoring
Primary	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	After 7 days of physical activity monitoring
Primary	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	After 7 days of physical activity monitoring
Primary	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.	After 7 days of physical activity monitoring
Primary	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.	After 7 days of physical activity monitoring
Primary	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.	After 7 days of physical activity monitoring
Primary	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.	After 7 days of physical activity monitoring
Primary	Arterial stiffness	Arterial stiffness will be determined by pulse wave analysis (PWA) and pulse wave velocity (PWV) using SphygmoCor (v9; Atcor Medical).	After 7 days of physical activity monitoring
Primary	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.	After 7 days of physical activity monitoring
Secondary	Steps per day	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	7 days
Secondary	Sitting time	Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	7 days
Secondary	Standing time	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	7 days
Secondary	Walking time	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	7 days
Secondary	Sleeping time	Participants will have to keep track of their sleeping time by means of a sleep diary	7 days
Secondary	Exercise information	Participants will have to keep track of their exercise information by means of a diary	7 days
Secondary	Total calorie intake	Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.	7 days
Secondary	Macronutrient content	Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.	7 days
Secondary	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).	After 7 days of physical activity monitoring
Secondary	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	After 7 days of physical activity monitoring
Secondary	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.	After 7 days of physical activity monitoring
Secondary	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.	After 7 days of physical activity monitoring