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Completed

NCT Number: NCT03919058

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Baseline activity (control regime)

Other

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)

Other

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)

Other

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)

Other

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.

Primary outcomes

  1. Steps per day

    Time frame: Day 1 to 4 of the control regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  2. Sitting time

    Time frame: Day 1 to 4 of the control regime

    Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  3. Standing time

    Time frame: Day 1 to 4 of the control regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  4. Stepping time

    Time frame: Day 1 to 4 of the control regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  5. Concentration of glucose

    Time frame: Day after the control regime

    Blood analysis

  6. Concentration of insulin

    Time frame: Day after the control regime

    Blood analysis

  7. Concentration of total cholesterol

    Time frame: Day after the control regime

    Blood analysis

  8. Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

    Time frame: Day after the control regime

    Blood analysis

  9. Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

    Time frame: Day after the control regime

    Blood analysis

  10. Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)

    Time frame: Day after the control regime

    Blood analysis

  11. Concentration of triglyceride

    Time frame: Day after the control regime

    Blood analysis

  12. Concentration of apolipoprotein A1 (apo A1)

    Time frame: Day after the control regime

    Blood analysis

  13. Concentration of apolipoprotein B (apo B)

    Time frame: Day after the control regime

    Blood analysis

  14. Concentration of free fatty acids (FFA)

    Time frame: Day after the control regime

    Blood analysis

  15. Concentration of C-reactive protein (CRP)

    Time frame: Day after the control regime

    Blood analysis

  16. Concentration of interleukin 1 (IL-1)

    Time frame: Day after the control regime

    Blood analysis

  17. Concentration of interleukin 6 (IL-6)

    Time frame: Day after the control regime

    Blood analysis

  18. Steps per day

    Time frame: Day 1 to 4 of the Sit regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  19. Sitting time

    Time frame: Dag 1 to 4 of the Sit regime

    Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  20. Standing time

    Time frame: Day 1 to 4 of the Sit regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  21. Stepping time

    Time frame: Day 1 to 4 of the Sit regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  22. Concentration of glucose

    Time frame: Day after the Sit regime

    Blood analysis

  23. Concentration of insulin

    Time frame: Day after the Sit regime

    Blood analysis

  24. Concentration of total cholesterol

    Time frame: Day after the Sit regime

    Blood analysis

  25. Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

    Time frame: Day after the Sit regime

    Blood analysis

  26. Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

    Time frame: Day after the Sit regime

    Blood analysis

  27. Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)

    Time frame: Day after the Sit regime

    Blood analysis

  28. Concentration of triglyceride

    Time frame: Day after the Sit regime

    Blood analysis

  29. Concentration of apolipoprotein A1 (apo A1)

    Time frame: Day after the Sit regime

    Blood analysis

  30. Concentration of apolipoprotein B (apo B)

    Time frame: Day after the Sit regime

    Blood analysis

  31. Concentration of free fatty acids (FFA)

    Time frame: Day after the Sit regime

    Blood analysis

  32. Concentration of C-reactive protein (CRP)

    Time frame: Day after the Sit regime

    Blood analysis

  33. Concentration of interleukin 1 (IL-1)

    Time frame: Day after the Sit regime

    Blood analysis

  34. Concentration of interleukin 6 (IL-6)

    Time frame: Day after the Sit regime

    Blood analysis

  35. Steps per day

    Time frame: Day 1 to 4 of the Sit Less regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  36. Sitting time

    Time frame: Day 1 to 4 of the Sit Less regime

    Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  37. Standing time

    Time frame: Day 1 to 4 of the Sit Less regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  38. Stepping time

    Time frame: Day 1 to 4 of the Sit Less regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  39. Concentration of glucose

    Time frame: Day after the Sit Less regime

    Blood analysis

  40. Concentration of insulin

    Time frame: Day after the Sit Less regime

    Blood analysis

  41. Concentration of total cholesterol

    Time frame: Day after the Sit Less regime

    Blood analysis

  42. Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

    Time frame: Day after the Sit Less regime

    Blood analysis

  43. Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

    Time frame: Day after the Sit Less regime

    Blood analysis

  44. Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)

    Time frame: Day after the Sit Less regime

    Blood analysis

  45. Concentration of triglyceride

    Time frame: Day after the Sit Less regime

    Blood analysis

  46. Concentration of apolipoprotein A1 (apo A1)

    Time frame: Day after the Sit Less regime

    Blood analysis

  47. Concentration of apolipoprotein B (apo B)

    Time frame: Day after the Sit Less regime

    Blood analysis

  48. Concentration of free fatty acids (FFA)

    Time frame: Day after the Sit Less regime

    Blood analysis

  49. Concentration of C-reactive protein (CRP)

    Time frame: Day after the Sit Less regime

    Blood analysis

  50. Concentration of interleukin 1 (IL-1)

    Time frame: Day after the Sit Less regime

    Blood analysis

  51. Concentration of interleukin 6 (IL-6)

    Time frame: Day after the Sit Less regime

    Blood analysis

  52. Steps per day

    Time frame: Day 1 to 4 of the Exercise regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  53. Sitting time

    Time frame: Day 1 to 4 of the Exercise regime

    Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  54. Standing time

    Time frame: Day 1 to 4 of the Exercise regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  55. Stepping time

    Time frame: Day 1 to 4 of the Exercise regime

    Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

  56. Concentration of glucose

    Time frame: Day after the Exercise regime

    Blood analysis

  57. Concentration of insulin

    Time frame: Day after the Exercise regime

    Blood analysis

  58. Concentration of total cholesterol

    Time frame: Day after the Exercise regime

    Blood analysis

  59. Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

    Time frame: Day after the Exercise regime

    Blood analysis

  60. Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

    Time frame: Day after the Exercise regime

    Blood analysis

  61. Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)

    Time frame: Day after the Exercise regime

    Blood analysis

  62. Concentration of triglyceride

    Time frame: Day after the Exercise regime

    Blood analysis

  63. Concentration of apolipoprotein A1 (apo A1)

    Time frame: Day after the Exercise regime

    Blood analysis

  64. Concentration of apolipoprotein B (apo B)

    Time frame: Day after the Exercise regime

    Blood analysis

  65. Concentration of free fatty acids (FFA)

    Time frame: Day after the Exercise regime

    Blood analysis

  66. Concentration of C-reactive protein (CRP)

    Time frame: Day after the Exercise regime

    Blood analysis

  67. Concentration of interleukin 1 (IL-1)

    Time frame: Day after the Exercise regime

    Blood analysis

  68. Concentration of interleukin 6 (IL-6)

    Time frame: Day after the Exercise regime

    Blood analysis

Secondary outcomes

  1. Blood pressure

    Time frame: Day after the Control 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.

  2. Body weight

    Time frame: Day after the Control regime

    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg

  3. Blood pressure

    Time frame: Day after the Sit 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.

  4. Body weight

    Time frame: Day after the Sit regime

    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg

  5. Blood pressure

    Time frame: Day after the Sit Less 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.

  6. Body weight

    Time frame: Day after the Sit Less regime

    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg

  7. Blood pressure

    Time frame: 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.

  8. Body weight

    Time frame: Day after the Exercise regime

    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2019
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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