Physical Activity, Sedentary Behaviour and Cardiometabolic Health in Multiple Sclerosis

NCT05752630 | Unknown

• 1 other identifier: CAMS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; Physical activity; Sedentary behaviour; Cardiometabolic health; Comorbidities

Outcome Measures

Primary Outcomes (24)

• 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.

  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

Secondary Outcomes (12)

• Steps per day

  7 days

• Sitting time

  7 days

• Standing time

  7 days

• Walking time

  7 days

• Sleeping time

  7 days

Study Arms (2)

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)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Bert Op 't Eijnde, prof.dr.

  Hasselt University

  STUDY CHAIR

• Ine Nieste, drs.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bert Op 't Eijnde, prof. dr.

CONTACT

+32 11 29 21 21; bert.opteijnde@uhasselt.be

Ine Nieste, drs.

CONTACT

+32496257499; ine.nieste@uhasselt.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: March 2, 2023
• Study Start: January 30, 2023
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

BE (1)