Sit Less or Exercise More: Impact on Cardiometabolic Health in MS
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Baseline activity (control regime)Other: Increased sitting time (sit regime)Other: Structured exercise (exercise regime)Other: Non-exercise physical activity (sit less regime)
- Registration Number
- NCT03919058
- Lead Sponsor
- Hasselt University
- Brief Summary
This study evaluates the impact of reducing sitting time and increasing exercise time on cardiometabolic health in persons with Multiple Sclerosis.
- Detailed Description
To date, it is clear that sedentary behaviour is strongly related to an increased risk of type II diabetes, cardiovascular disease and premature mortality. People suffering from chronic disabilities appear to be particularly susceptible to a sedentary lifestyle and inactivity due to primary disease symptoms. To date, this is an important new research topic in Multiple Sclerosis (MS, \~2.3 million people worldwide, \~10-12.000 diagnosed in Belgium) treatment, since previous research reported a significantly higher prevalence of sedentary behaviour in persons with MS (PwMS) compared to healthy controls (HC). PwMS are reported to have a 40% lower daily step count compared to healthy inactive persons and tend to accumulate their sedentary time in longer bouts. As described above and similar to other chronic conditions, a sedentary lifestyle also makes PwMS more vulnerable to the accumulation of important cardiometabolic comorbidities that seem inactivity-related rather than a direct result of non-reversible tissue injury. Such comorbidities include impaired whole body glycaemic control, an abnormal blood lipid profile, an unhealthy body composition and hypertension. In this respect, it is important to note that corticosteroids, which are often used to treat MS patients pharmacologically, elevate fasting glucose and insulin concentrations and induce insulin resistance in HC therefore probably also increase several cardiometabolic risk factors in MS.
Up to now, research in MS has been focused on structured exercise and its positive effects on functional parameters are well-known (e.g. improvements in cardiorespiratory fitness, muscle strength, balance, fatigue, cognition, quality of life and respiratory function). However, evidence is growing that sedentary time, independent of the (dis)practice of structured exercise, is an important independent health risk factor. Consequently, any strategy that also improves cardiometabolic health may help to further optimize rehabilitation in MS. Breaking up and reducing sedentary time with easy, daily activities such as household activities and other activities which increase light-intensity walking and standing, known as non-exercise physical activity (NEPA) may be such a strategy.
NEPA has already been shown to significantly improve cardiometabolic risk markers in healthy, sedentary subjects, type II diabetes patients and obese adults and it involves lower intensity physical activities that are probably more feasible for PwMS. Moreover, with comparable activity workloads, reducing sitting time by NEPA of longer duration decreases insulin levels and fasting lipid levels more than performing one structured exercise bout of moderate intensity that is usually described in current activity guidelines. So far however, acute exercise bouts and NEPA effects on cardiometabolic health in this population have never been described. Therefore, the aim of this study is to investigate whether (1) cardiometabolic health (glycaemic control, blood lipids, inflammation markers and blood pressure) of persons with MS improves when sedentary time is reduced and (2) NEPA results in better cardiometabolic health parameters than (a shorter daily bout of) moderate-intensity exercise when workload of both activities is identical in this population.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Signed informed consent
- Men and women ≥18 years old
- Clinical diagnosis of MS (McDonald criteria)
- Expanded Disability Status Score ≤ 5
- Daily internet access
- Reported participation in another biomedical trial which may have an effect on blood parameters one month before the pre-study examination or during the study
- Blood donation in the past three months
- Pregnancy or intention of becoming pregnant
- Reported dietary habits: medically prescribed diet, slimming diet
- Reported weight loss (>2kg) in the last three months prior to the screening
- Alcohol use > 20 units per week (during the last 3 months)
- Experimental drug use (during the last 3 months)
- Medication changes (during the last month)
- Medical conditions which make participation in the study not responsible:
- Heart failure: New York Heart Association (NYHA) 3 or higher
- Angina pectoris or signs of cardiac ischemia during exercise testing
- Mental or physical disability
- Based on historical information not able to walk for 3h per day and stand for 4h per day (e.g. intermittent claudication)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Regime 1: control regime Baseline activity (control regime) All participants start with the control regime, where baseline activity will be measured. Regime 2: Sit regime/sit less regime Non-exercise physical activity (sit less regime) The order of the regimes will be randomized, half of the participants will execute the sit regime as second regime, the other half will execute the sit less regime as second regime. Subjects have to follow a pre-defined activity protocol and receive an activity tracker (Polar M200) in order to self-monitor their activity. Regime 2: Sit regime/sit less regime Increased sitting time (sit regime) The order of the regimes will be randomized, half of the participants will execute the sit regime as second regime, the other half will execute the sit less regime as second regime. Subjects have to follow a pre-defined activity protocol and receive an activity tracker (Polar M200) in order to self-monitor their activity. Regime 4: Exercise regime Structured exercise (exercise regime) The exercise regime is the final regime for all participants. This is comparable with the sit regime, but 1h of sitting is replaced with 1 exercise bout. Regime 3: Sit less regime/sit regime Increased sitting time (sit regime) The order of the regimes will be randomized, half of the participants will execute the sit regime as second regime, the other half will execute the sit less regime as second regime. Subjects have to follow a pre-defined activity protocol and receive an activity tracker (Polar M200) in order to self-monitor their activity. Regime 3: Sit less regime/sit regime Non-exercise physical activity (sit less regime) The order of the regimes will be randomized, half of the participants will execute the sit regime as second regime, the other half will execute the sit less regime as second regime. Subjects have to follow a pre-defined activity protocol and receive an activity tracker (Polar M200) in order to self-monitor their activity.
- Primary Outcome Measures
Name Time Method Standing time Day 1 to 4 of the Exercise regime Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Concentration of high density lipoprotein cholesterol (HDL-cholesterol) Day after the Exercise regime Blood analysis
Concentration of low density lipoprotein cholesterol (LDL-cholesterol) Day after the Exercise regime Blood analysis
Concentration of interleukin 1 (IL-1) Day after the Exercise regime Blood analysis
Concentration of glucose Day after the Exercise regime Blood analysis
Concentration of insulin Day after the Exercise regime Blood analysis
Steps per day Day 1 to 4 of the Exercise regime Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Concentration of apolipoprotein A1 (apo A1) Day after the Exercise regime Blood analysis
Concentration of apolipoprotein B (apo B) Day after the Exercise regime Blood analysis
Sitting time Day 1 to 4 of the Exercise regime Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Concentration of free fatty acids (FFA) Day after the Exercise regime Blood analysis
Concentration of C-reactive protein (CRP) Day after the Exercise regime Blood analysis
Stepping time Day 1 to 4 of the Exercise regime Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).
Concentration of total cholesterol Day after the Exercise regime Blood analysis
Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol) Day after the Exercise regime Blood analysis
Concentration of triglyceride Day after the Exercise regime Blood analysis
Concentration of interleukin 6 (IL-6) Day after the Exercise regime Blood analysis
- Secondary Outcome Measures
Name Time Method Body weight Day after the Exercise regime Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Blood pressure Day after the Exercise regime Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer (Omron®, Omron Healthcare, IL, USA) from the dominant arm and documented as the mean value of the final 2 measurements.
Trial Locations
- Locations (1)
Hasselt University
🇧🇪Diepenbeek, Limburg, Belgium