NCT05752630|Unknown
Physical Activity, Sedentary Behaviour and Cardiometabolic Health in Multiple Sclerosis
The Relation Between Physical Activity, Sedentary Behaviour, and Cardiometabolic Health in Multiple Sclerosis
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The Relation Between Physical Activity, Sedentary Behaviour, and Cardiometabolic Health in Multiple Sclerosis
Sponsor study identifier
observational
50
1 country
1
Study Start
January 30, 2023
Actual (reported)Primary Completion
January 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study evaluates the association between sedentary behaviour, physical activity, and the cardiometabolic health of Multiple Sclerosis via several cardiovascular, metabolic and anthropometric parameters.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2023
Actual (reported)February 1, 2023
Actual (reported)March 2, 2023
Actual (reported)January 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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
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.
Steps per day
7 days
Sitting time
7 days
Standing time
7 days
Walking time
7 days
Sleeping time
7 days
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 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)
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.
Hasselt University
Diepenbeek, Limburg, 3590, Belgium
Blood samples
Bert Op 't Eijnde, prof.dr.
Hasselt University
Ine Nieste, drs.
Hasselt University
First Submitted
February 1, 2023
First Posted
March 2, 2023
Study Start
January 30, 2023
Actual (reported)Primary Completion
January 20, 2024
Estimated (date passed)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.
After 7 days of physical activity monitoring
Concentration of glucose
Concentration of glucose measured in blood analysis during OGTT
After 7 days of physical activity monitoring
Concentration of Insulin
Blood analysis of insulin during OGTT
After 7 days of physical activity monitoring
Concentration of total cholesterol
Blood analysis
After 7 days of physical activity monitoring
Concentration of high density lipoprotein cholesterol (HDL-cholesterol
Blood analysis
After 7 days of physical activity monitoring
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Blood analysis
After 7 days of physical activity monitoring
Concentration of triglyceride
Blood analysis
After 7 days of physical activity monitoring
Concentration of inflammatory markers
blood analysis of IL-6, TNF-α and C-reactive protein
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.
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.
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.
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
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
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
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.
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.
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.
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.
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).
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.
After 7 days of physical activity monitoring
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 2, 2023
Record last verified: 2023-03
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