Clinical trial NCT03919058: Sit Less or Exercise More: Impact on Cardiometabolic Health in MS
Official title: Sit Less or Exercise More: Impact on Cardiometabolic Health in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Non-exercise physical activity
NEPA
Cardiometabolic health
Comorbidities
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will follow four regimes of 4 days each including a control, a sit less, a sit and an exercise regime. The order of the sit and sit less regimes will be randomized. Each activity regime will be followed by a wash-out period of 10 days during which subjects will continue their normal lifestyle.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Men and women ≥18 years old
* Clinical diagnosis of MS (McDonald criteria)
* Expanded Disability Status Score ≤ 5
* Daily internet access

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Steps per day
timeFrame: Day 1 to 4 of the control regime
measure: Sitting time
timeFrame: Day 1 to 4 of the control regime
measure: Standing time
timeFrame: Day 1 to 4 of the control regime
measure: Stepping time
timeFrame: Day 1 to 4 of the control regime
measure: Concentration of glucose
timeFrame: Day after the control regime
measure: Concentration of insulin
timeFrame: Day after the control regime
measure: Concentration of total cholesterol
timeFrame: Day after the control regime
measure: Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
timeFrame: Day after the control regime
measure: Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
timeFrame: Day after the control regime
measure: Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
timeFrame: Day after the control regime
measure: Concentration of triglyceride
timeFrame: Day after the control regime
measure: Concentration of apolipoprotein A1 (apo A1)
timeFrame: Day after the control regime
measure: Concentration of apolipoprotein B (apo B)
timeFrame: Day after the control regime
measure: Concentration of free fatty acids (FFA)
timeFrame: Day after the control regime
measure: Concentration of C-reactive protein (CRP)
timeFrame: Day after the control regime
measure: Concentration of interleukin 1 (IL-1)
timeFrame: Day after the control regime
measure: Concentration of interleukin 6 (IL-6)
timeFrame: Day after the control regime
measure: Steps per day
timeFrame: Day 1 to 4 of the Sit regime
measure: Sitting time
timeFrame: Dag 1 to 4 of the Sit regime
measure: Standing time
timeFrame: Day 1 to 4 of the Sit regime
measure: Stepping time
timeFrame: Day 1 to 4 of the Sit regime
measure: Concentration of glucose
timeFrame: Day after the Sit regime
measure: Concentration of insulin
timeFrame: Day after the Sit regime
measure: Concentration of total cholesterol
timeFrame: Day after the Sit regime
measure: Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
timeFrame: Day after the Sit regime
measure: Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
timeFrame: Day after the Sit regime
measure: Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
timeFrame: Day after the Sit regime
measure: Concentration of triglyceride
timeFrame: Day after the Sit regime
measure: Concentration of apolipoprotein A1 (apo A1)
timeFrame: Day after the Sit regime
measure: Concentration of apolipoprotein B (apo B)
timeFrame: Day after the Sit regime
measure: Concentration of free fatty acids (FFA)
timeFrame: Day after the Sit regime
measure: Concentration of C-reactive protein (CRP)
timeFrame: Day after the Sit regime
measure: Concentration of interleukin 1 (IL-1)
timeFrame: Day after the Sit regime
measure: Concentration of interleukin 6 (IL-6)
timeFrame: Day after the Sit regime
measure: Steps per day
timeFrame: Day 1 to 4 of the Sit Less regime
measure: Sitting time
timeFrame: Day 1 to 4 of the Sit Less regime
measure: Standing time
timeFrame: Day 1 to 4 of the Sit Less regime
measure: Stepping time
timeFrame: Day 1 to 4 of the Sit Less regime
measure: Concentration of glucose
timeFrame: Day after the Sit Less regime
measure: Concentration of insulin
timeFrame: Day after the Sit Less regime
measure: Concentration of total cholesterol
timeFrame: Day after the Sit Less regime
measure: Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
timeFrame: Day after the Sit Less regime
measure: Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
timeFrame: Day after the Sit Less regime
measure: Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
timeFrame: Day after the Sit Less regime
measure: Concentration of triglyceride
timeFrame: Day after the Sit Less regime
measure: Concentration of apolipoprotein A1 (apo A1)
timeFrame: Day after the Sit Less regime
measure: Concentration of apolipoprotein B (apo B)
timeFrame: Day after the Sit Less regime
measure: Concentration of free fatty acids (FFA)
timeFrame: Day after the Sit Less regime
measure: Concentration of C-reactive protein (CRP)
timeFrame: Day after the Sit Less regime
measure: Concentration of interleukin 1 (IL-1)
timeFrame: Day after the Sit Less regime
measure: Concentration of interleukin 6 (IL-6)
timeFrame: Day after the Sit Less regime
measure: Steps per day
timeFrame: Day 1 to 4 of the Exercise regime
measure: Sitting time
timeFrame: Day 1 to 4 of the Exercise regime
measure: Standing time
timeFrame: Day 1 to 4 of the Exercise regime
measure: Stepping time
timeFrame: Day 1 to 4 of the Exercise regime
measure: Concentration of glucose
timeFrame: Day after the Exercise regime
measure: Concentration of insulin
timeFrame: Day after the Exercise regime
measure: Concentration of total cholesterol
timeFrame: Day after the Exercise regime
measure: Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
timeFrame: Day after the Exercise regime
measure: Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
timeFrame: Day after the Exercise regime
measure: Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)
timeFrame: Day after the Exercise regime
measure: Concentration of triglyceride
timeFrame: Day after the Exercise regime
measure: Concentration of apolipoprotein A1 (apo A1)
timeFrame: Day after the Exercise regime
measure: Concentration of apolipoprotein B (apo B)
timeFrame: Day after the Exercise regime
measure: Concentration of free fatty acids (FFA)
timeFrame: Day after the Exercise regime
measure: Concentration of C-reactive protein (CRP)
timeFrame: Day after the Exercise regime
measure: Concentration of interleukin 1 (IL-1)
timeFrame: Day after the Exercise regime
measure: Concentration of interleukin 6 (IL-6)
timeFrame: Day after the Exercise regime
Secondary outcomes:
measure: Blood pressure
timeFrame: Day after the Control regime
measure: Body weight
timeFrame: Day after the Control regime
measure: Blood pressure
timeFrame: Day after the Sit regime
measure: Body weight
timeFrame: Day after the Sit regime
measure: Blood pressure
timeFrame: Day after the Sit Less regime
measure: Body weight
timeFrame: Day after the Sit Less regime
measure: Blood pressure
timeFrame: Day after the Exercise regime
measure: Body weight
timeFrame: Day after the Exercise regime
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
References:
citation: Nieste I, Franssen WMA, Duvivier BMFM, Spaas J, Savelberg HHCM, Eijnde BO. Replacing sitting with light-intensity physical activity throughout the day versus 1 bout of vigorous-intensity exercise: similar cardiometabolic health effects in multiple sclerosis. A randomised cross-over study. Disabil Rehabil. 2023 Oct;45(20):3293-3302. doi: 10.1080/09638288.2022.2122601. Epub 2022 Oct 3.