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

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ClinicalTrials.gov Identifier: NCT03919058
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bert Op't Eijnde, 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Baseline activity (control regime) Other: Increased sitting time (sit regime) Other: Non-exercise physical activity (sit less regime) Other: Structured exercise (exercise regime) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will not know the code of the different regimes.
Primary Purpose: Prevention
Official Title: Sit Less or Exercise More: Impact on Cardiometabolic Health in Multiple Sclerosis
Estimated Study Start Date : April 13, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Regime 1: control regime
All participants start with the control regime, where baseline activity will be measured.
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.

Experimental: Regime 2: Sit regime/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.
Other: 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.

Other: 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).

Experimental: Regime 3: Sit less regime/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.
Other: 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.

Other: 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).

Experimental: Regime 4: 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.
Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919058


Contacts
Layout table for location contacts
Contact: Bert Op 't Eijnde, Prof. dr. +3211292121 bert.opteijnde@uhasselt.be
Contact: Ine Nieste, Drs. +3211269350 ine.nieste@uhasselt.be

Locations
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Belgium
Hasselt University Recruiting
Diepenbeek, Limburg, Belgium, 3590
Contact: Bert Op't Eijnde, Prof. dr.    +3211292121    bert.opteijnde@uhasselt.be   
Contact: Ine Nieste, drs.    +3211269350    ine.nieste@uhasselt.be   
Principal Investigator: Bert Op 't Eijnde, Prof. dr.         
Sub-Investigator: Ine Nieste, drs.         
Sponsors and Collaborators
Hasselt University
Investigators
Layout table for investigator information
Study Chair: Bert Op 't Eijnde, Prof. dr. Hasselt University
  Study Documents (Full-Text)

Documents provided by Bert Op't Eijnde, Hasselt University:

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Responsible Party: Bert Op't Eijnde, Prof. dr. Bert Op't Eijnde, Hasselt University
ClinicalTrials.gov Identifier: NCT03919058     History of Changes
Other Study ID Numbers: RST-MS
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bert Op't Eijnde, Hasselt University:
Multiple Sclerosis
Non-exercise physical activity
NEPA
Cardiometabolic health
Comorbidities

Additional relevant MeSH terms:
Layout table for MeSH terms
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases