NCT03919058

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

April 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

April 12, 2019

Last Update Submit

August 30, 2021

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisNon-exercise physical activityNEPACardiometabolic healthComorbidities

Outcome Measures

Primary Outcomes (68)

  • 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

  • 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

  • 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

  • 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

  • Concentration of glucose

    Blood analysis

    Day after the control regime

  • Concentration of insulin

    Blood analysis

    Day after the control regime

  • Concentration of total cholesterol

    Blood analysis

    Day after the control regime

  • Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

    Blood analysis

    Day after the control regime

  • Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

    Blood analysis

    Day after the control regime

  • Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)

    Blood analysis

    Day after the control regime

  • Concentration of triglyceride

    Blood analysis

    Day after the control regime

  • Concentration of apolipoprotein A1 (apo A1)

    Blood analysis

    Day after the control regime

  • Concentration of apolipoprotein B (apo B)

    Blood analysis

    Day after the control regime

  • Concentration of free fatty acids (FFA)

    Blood analysis

    Day after the control regime

  • Concentration of C-reactive protein (CRP)

    Blood analysis

    Day after the control regime

  • Concentration of interleukin 1 (IL-1)

    Blood analysis

    Day after the control regime

  • Concentration of interleukin 6 (IL-6)

    Blood analysis

    Day after the control regime

  • 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

  • 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

  • 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

  • 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

  • Concentration of glucose

    Blood analysis

    Day after the Sit regime

  • Concentration of insulin

    Blood analysis

    Day after the Sit regime

  • Concentration of total cholesterol

    Blood analysis

    Day after the Sit regime

  • Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

    Blood analysis

    Day after the Sit regime

  • Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

    Blood analysis

    Day after the Sit regime

  • Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)

    Blood analysis

    Day after the Sit regime

  • Concentration of triglyceride

    Blood analysis

    Day after the Sit regime

  • Concentration of apolipoprotein A1 (apo A1)

    Blood analysis

    Day after the Sit regime

  • Concentration of apolipoprotein B (apo B)

    Blood analysis

    Day after the Sit regime

  • Concentration of free fatty acids (FFA)

    Blood analysis

    Day after the Sit regime

  • Concentration of C-reactive protein (CRP)

    Blood analysis

    Day after the Sit regime

  • Concentration of interleukin 1 (IL-1)

    Blood analysis

    Day after the Sit regime

  • Concentration of interleukin 6 (IL-6)

    Blood analysis

    Day after the Sit regime

  • 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

  • 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

  • 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

  • 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

  • Concentration of glucose

    Blood analysis

    Day after the Sit Less regime

  • Concentration of insulin

    Blood analysis

    Day after the Sit Less regime

  • Concentration of total cholesterol

    Blood analysis

    Day after the Sit Less regime

  • Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

    Blood analysis

    Day after the Sit Less regime

  • Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

    Blood analysis

    Day after the Sit Less regime

  • Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)

    Blood analysis

    Day after the Sit Less regime

  • Concentration of triglyceride

    Blood analysis

    Day after the Sit Less regime

  • Concentration of apolipoprotein A1 (apo A1)

    Blood analysis

    Day after the Sit Less regime

  • Concentration of apolipoprotein B (apo B)

    Blood analysis

    Day after the Sit Less regime

  • Concentration of free fatty acids (FFA)

    Blood analysis

    Day after the Sit Less regime

  • Concentration of C-reactive protein (CRP)

    Blood analysis

    Day after the Sit Less regime

  • Concentration of interleukin 1 (IL-1)

    Blood analysis

    Day after the Sit Less regime

  • Concentration of interleukin 6 (IL-6)

    Blood analysis

    Day after the Sit Less regime

  • 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

  • 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

  • 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

  • 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

  • Concentration of glucose

    Blood analysis

    Day after the Exercise regime

  • Concentration of insulin

    Blood analysis

    Day after the Exercise regime

  • Concentration of total cholesterol

    Blood analysis

    Day after the Exercise regime

  • Concentration of high density lipoprotein cholesterol (HDL-cholesterol)

    Blood analysis

    Day after the Exercise regime

  • Concentration of low density lipoprotein cholesterol (LDL-cholesterol)

    Blood analysis

    Day after the Exercise regime

  • Concentration of non-high densitiy lipoprotein cholesterol (non-HDL cholesterol)

    Blood analysis

    Day after the Exercise regime

  • Concentration of triglyceride

    Blood analysis

    Day after the Exercise regime

  • Concentration of apolipoprotein A1 (apo A1)

    Blood analysis

    Day after the Exercise regime

  • Concentration of apolipoprotein B (apo B)

    Blood analysis

    Day after the Exercise regime

  • Concentration of free fatty acids (FFA)

    Blood analysis

    Day after the Exercise regime

  • Concentration of C-reactive protein (CRP)

    Blood analysis

    Day after the Exercise regime

  • Concentration of interleukin 1 (IL-1)

    Blood analysis

    Day after the Exercise regime

  • Concentration of interleukin 6 (IL-6)

    Blood analysis

    Day after the Exercise regime

Secondary Outcomes (8)

  • Blood pressure

    Day after the Control regime

  • Body weight

    Day after the Control regime

  • Blood pressure

    Day after the Sit regime

  • Body weight

    Day after the Sit regime

  • Blood pressure

    Day after the Sit Less regime

  • +3 more secondary outcomes

Study Arms (4)

Regime 1: control regime

ACTIVE COMPARATOR

All participants start with the control regime, where baseline activity will be measured.

Other: Baseline activity (control regime)

Regime 2: Sit regime/sit less regime

EXPERIMENTAL

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)Other: Non-exercise physical activity (sit less regime)

Regime 3: Sit less regime/sit regime

EXPERIMENTAL

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)Other: Non-exercise physical activity (sit less regime)

Regime 4: Exercise regime

EXPERIMENTAL

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)

Interventions

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.

Regime 1: control regime
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.

Regime 2: Sit regime/sit less regimeRegime 3: Sit less regime/sit regime
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).

Regime 2: Sit regime/sit less regimeRegime 3: Sit less regime/sit regime
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.

Regime 4: Exercise regime

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 36190113DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bert Op 't Eijnde, Prof. dr.

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will not know the code of the different regimes.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Bert Op't Eijnde

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 18, 2019

Study Start

April 13, 2019

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations

BE(1)