Sit Less or Exercise More: Impact on Cardiometabolic Health in MS

Multiple Sclerosis Clinical Trial

Official title:

Sit Less or Exercise More: Impact on Cardiometabolic Health in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919058
• Other study ID #: RST-MS
• Status: Completed
• Phase: N/A
• Start date: April 13, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: August 2021
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the impact of reducing sitting time and increasing exercise time on cardiometabolic health in persons with Multiple Sclerosis.

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Baseline activity (control regime)
This is a baseline measurement of physical activity during which subjects will be instructed not to change activity patterns during four days and to note all activities they perform.
• Increased sitting time (sit regime)
Participants have to spend 14h of their day sitting, 1h walking and 1h standing, for four consecutive days. According to the compendium of Ainsworth et al. (2011), this corresponds with a daily workload of activities (DWA) of 27 metabolic equivalents (MET's) per day.
• Non-exercise physical activity (sit less regime)
Each day (4 days in total) will consist of 3h walking, 4h standing and 9h sitting. These time frames are chosen to result in a comparable DWA increase as the exercise regime compared to the sit regime (+7 MET's)27. The additional 2h of walking and 3h of standing, compared to the sitting regime, will be done in a minimum of four bouts with a time interval of > 1h. The subjects will be instructed to walk on a slow pace. i.e. 2-3 km/h (e.g. walking during shopping and work related walking in an office).
• Structured exercise (exercise regime)
One hour of sitting in the sit regime will be replaced with 1 training session (1h) on a cycle ergometer in the research center. The remaining hours of each day (4 days in total) have to be spent as follows: 13h sitting, 1h walking and 1h standing for daily care. The intensity of the training session (50-60% of Wmax) results in a DWA of 34.5 MET's according to the compendium of physical activities. Duration of training sessions will be adapted individually with ActivPAL data of the sit less and sit regime to identically match DWA increase between the sit less and exercise regime, compared to the sitting regime.

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	Steps per day	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the control regime
Primary	Sitting time	Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the control regime
Primary	Standing time	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the control regime
Primary	Stepping time	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the control regime
Primary	Concentration of glucose	Blood analysis	Day after the control regime
Primary	Concentration of insulin	Blood analysis	Day after the control regime
Primary	Concentration of total cholesterol	Blood analysis	Day after the control regime
Primary	Concentration of high density lipoprotein cholesterol (HDL-cholesterol)	Blood analysis	Day after the control regime
Primary	Concentration of low density lipoprotein cholesterol (LDL-cholesterol)	Blood analysis	Day after the control regime
Primary	Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)	Blood analysis	Day after the control regime
Primary	Concentration of triglyceride	Blood analysis	Day after the control regime
Primary	Concentration of apolipoprotein A1 (apo A1)	Blood analysis	Day after the control regime
Primary	Concentration of apolipoprotein B (apo B)	Blood analysis	Day after the control regime
Primary	Concentration of free fatty acids (FFA)	Blood analysis	Day after the control regime
Primary	Concentration of C-reactive protein (CRP)	Blood analysis	Day after the control regime
Primary	Concentration of interleukin 1 (IL-1)	Blood analysis	Day after the control regime
Primary	Concentration of interleukin 6 (IL-6)	Blood analysis	Day after the control regime
Primary	Steps per day	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Sit regime
Primary	Sitting time	Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Dag 1 to 4 of the Sit regime
Primary	Standing time	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Sit regime
Primary	Stepping time	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Sit regime
Primary	Concentration of glucose	Blood analysis	Day after the Sit regime
Primary	Concentration of insulin	Blood analysis	Day after the Sit regime
Primary	Concentration of total cholesterol	Blood analysis	Day after the Sit regime
Primary	Concentration of high density lipoprotein cholesterol (HDL-cholesterol)	Blood analysis	Day after the Sit regime
Primary	Concentration of low density lipoprotein cholesterol (LDL-cholesterol)	Blood analysis	Day after the Sit regime
Primary	Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)	Blood analysis	Day after the Sit regime
Primary	Concentration of triglyceride	Blood analysis	Day after the Sit regime
Primary	Concentration of apolipoprotein A1 (apo A1)	Blood analysis	Day after the Sit regime
Primary	Concentration of apolipoprotein B (apo B)	Blood analysis	Day after the Sit regime
Primary	Concentration of free fatty acids (FFA)	Blood analysis	Day after the Sit regime
Primary	Concentration of C-reactive protein (CRP)	Blood analysis	Day after the Sit regime
Primary	Concentration of interleukin 1 (IL-1)	Blood analysis	Day after the Sit regime
Primary	Concentration of interleukin 6 (IL-6)	Blood analysis	Day after the Sit regime
Primary	Steps per day	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Sit Less regime
Primary	Sitting time	Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Sit Less regime
Primary	Standing time	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Sit Less regime
Primary	Stepping time	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Sit Less regime
Primary	Concentration of glucose	Blood analysis	Day after the Sit Less regime
Primary	Concentration of insulin	Blood analysis	Day after the Sit Less regime
Primary	Concentration of total cholesterol	Blood analysis	Day after the Sit Less regime
Primary	Concentration of high density lipoprotein cholesterol (HDL-cholesterol)	Blood analysis	Day after the Sit Less regime
Primary	Concentration of low density lipoprotein cholesterol (LDL-cholesterol)	Blood analysis	Day after the Sit Less regime
Primary	Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)	Blood analysis	Day after the Sit Less regime
Primary	Concentration of triglyceride	Blood analysis	Day after the Sit Less regime
Primary	Concentration of apolipoprotein A1 (apo A1)	Blood analysis	Day after the Sit Less regime
Primary	Concentration of apolipoprotein B (apo B)	Blood analysis	Day after the Sit Less regime
Primary	Concentration of free fatty acids (FFA)	Blood analysis	Day after the Sit Less regime
Primary	Concentration of C-reactive protein (CRP)	Blood analysis	Day after the Sit Less regime
Primary	Concentration of interleukin 1 (IL-1)	Blood analysis	Day after the Sit Less regime
Primary	Concentration of interleukin 6 (IL-6)	Blood analysis	Day after the Sit Less regime
Primary	Steps per day	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Exercise regime
Primary	Sitting time	Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Exercise regime
Primary	Standing time	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Exercise regime
Primary	Stepping time	Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).	Day 1 to 4 of the Exercise regime
Primary	Concentration of glucose	Blood analysis	Day after the Exercise regime
Primary	Concentration of insulin	Blood analysis	Day after the Exercise regime
Primary	Concentration of total cholesterol	Blood analysis	Day after the Exercise regime
Primary	Concentration of high density lipoprotein cholesterol (HDL-cholesterol)	Blood analysis	Day after the Exercise regime
Primary	Concentration of low density lipoprotein cholesterol (LDL-cholesterol)	Blood analysis	Day after the Exercise regime
Primary	Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)	Blood analysis	Day after the Exercise regime
Primary	Concentration of triglyceride	Blood analysis	Day after the Exercise regime
Primary	Concentration of apolipoprotein A1 (apo A1)	Blood analysis	Day after the Exercise regime
Primary	Concentration of apolipoprotein B (apo B)	Blood analysis	Day after the Exercise regime
Primary	Concentration of free fatty acids (FFA)	Blood analysis	Day after the Exercise regime
Primary	Concentration of C-reactive protein (CRP)	Blood analysis	Day after the Exercise regime
Primary	Concentration of interleukin 1 (IL-1)	Blood analysis	Day after the Exercise regime
Primary	Concentration of interleukin 6 (IL-6)	Blood analysis	Day after the Exercise regime
Secondary	Blood pressure	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.	Day after the Control regime
Secondary	Body weight	Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg	Day after the Control regime
Secondary	Blood pressure	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.	Day after the Sit regime
Secondary	Body weight	Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg	Day after the Sit regime
Secondary	Blood pressure	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.	Day after the Sit Less regime
Secondary	Body weight	Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg	Day after the Sit Less regime
Secondary	Blood pressure	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.	Day after the Exercise regime
Secondary	Body weight	Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg	Day after the Exercise regime