NCT04191772

Brief Summary

The current study aims to investigate whether persons with Multiple Sclerosis (PwMS) compensate training time with more sedentary time and consequently blunt training effects. The second aim will be to investigate the effect of a structured training program on specific brain volumes and cognitive variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2020

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

December 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

December 5, 2019

Last Update Submit

August 30, 2021

Conditions

Multiple Sclerosis

Keywords

Sedentary timeExerciseBrain volumeHealth-related variablesImmunological variablesMultiple Sclerosis

Outcome Measures

Primary Outcomes (20)

  • Number of steps per day

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

    Before start of the training program

  • Number of steps per day

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

    Week 1 of the training program

  • Number of steps per day

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

    Week 24 of the training program

  • Number of steps per day

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

    Week 48 of the training program

  • Number of steps per day

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

    3 months after the training program

  • Sitting time

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

    Before start of the training program

  • Sitting time

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

    Week 1 of the training program

  • Sitting time

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

    Week 24 of the training program

  • Sitting time

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

    Week 48 of the training program

  • Sitting time

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

    3 months after the training program

  • Standing time

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

    Before start of the training program

  • Standing time

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

    Week 1 of the training program

  • Standing time

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

    Week 24 of the training program

  • Standing time

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

    Week 48 of the training program

  • Standing time

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

    3 months after the training program

  • Stepping time

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

    Before start of the training program

  • Stepping time

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

    Week 1 of the training program

  • Stepping time

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

    Week 24 of the training program

  • Stepping time

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

    Week 48 of the training program

  • Stepping time

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

    3 months after the training program

Secondary Outcomes (62)

  • Blood pressure

    Baseline

  • Blood pressure

    Week 48 of the training program

  • Resting heart rate

    Baseline

  • Resting heart rate

    Week 48 of the training program

  • Total calorie intake

    Baseline

  • +57 more secondary outcomes

Study Arms (6)

MS - training goal 1

EXPERIMENTAL

Persons with Multiple Sclerosis (PwMS) with a 'poor VO2max', a 'fair VO2max' with no running experience and a 'good VO2max' with no running experience (VO2max values according to V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics) will receive an exercise intervention existing of home-based running sessions. Participants of the first training group will be trained to run continuously for 45 minutes.

Other: Periodized, home-based running program

HC - training goal 1

EXPERIMENTAL

Healthy control (HC) persons with a 'poor VO2max', a 'fair VO2max' with no running experience and a 'good VO2max' with no running experience (VO2max values according to V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics) will receive an exercise intervention existing of home-based running sessions. Participants of the first training group will be trained to run continuously for 45 minutes.

Other: Periodized, home-based running program

MS - training goal 2

EXPERIMENTAL

PwMS with a 'fair VO2max' and running experience, a 'good VO2max and running experience', an 'excellent VO2max' and a 'superior VO2max' (VO2max values according to V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics) will receive an exercise intervention existing of home-based running sessions. Participants of the second training group will be trained to run continuously for 75 minutes.

Other: Periodized, home-based running program

HC - training goal 2

EXPERIMENTAL

HC with a 'fair VO2max' and running experience, a 'good VO2max and running experience', an 'excellent VO2max' and a 'superior VO2max' (VO2max values according to V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics) will receive an exercise intervention existing of home-based running sessions. Participants of the second training group will be trained to run continuously for 75 minutes.

Other: Periodized, home-based running program

MS - sedentary control group

NO INTERVENTION

Twenty PwMS will receive no intervention, only usual care.

HC - sedentary control group

NO INTERVENTION

Twenty HC will receive no intervention, only usual care.

Interventions

Periodized, home-based running programOTHER

All participants will perform a home-based supervised exercise training program. Participants will receive weekly training instructions using a smartphone-based heart rate monitor application (Polar® app). Training sessions will involve running and the design of the training program will be based on linear periodization, where aerobic capacity is built firstly through a period of high-volume/low-intensity training before the proportion of high-intensity training is increased. The total duration of the exercise program will be 12 months with three weekly training sessions. Training progression will be dependent on initial VO2max values and running experience. VO2max classification is based on reference values described in V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics.

HC - training goal 1HC - training goal 2MS - training goal 1MS - training goal 2

Eligibility Criteria

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

You may qualify if:

  • Multiple Sclerosis according to the McDonald criteria (Relaps remitting)
  • Written informed consent
  • Medical safety screening

You may not qualify if:

  • Contra-indications to participate in moderate to high intensity exercise
  • Contra-indications to undergo magnetic resonance imaging (pacemaker/defibrillator or wires other than sternal wires, insulin pumps, metal foreign bodies, deep brain stimulator, cerebral aneurysm clips, cochlear implant, magnetic dental implant, drug infusion device)
  • Medication changes in the last month before the start of the intervention
  • Following or plan to follow a weight reduction program
  • Pregnancy
  • Participation in another study
  • Acute MS exacerbation \< 3 months prior to the start of the study
  • EDSS score \> 4
  • Consumption of more than 20 alcohol units/week
  • No daily internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

Location

Related Publications (1)

  • Nieste I, Spaas J, Franssen WMA, Asch PV, Savelberg HHCM, Eijnde BO. The effect of a structured running exercise intervention on non-exercise physical activity and sedentary behaviour in persons with mild Multiple Sclerosis and healthy controls. J Act Sedentary Sleep Behav. 2023 Dec 4;2(1):29. doi: 10.1186/s44167-023-00037-1.

    PMID: 40217416DERIVED

MeSH Terms

Conditions

Multiple SclerosisSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bert Op 't Eijnde, Prof. dr.

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will receive an intervention (exercise program) or no intervention (sedentary control group). Participants will be persons with MS and healthy controls.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2019

First Posted

December 10, 2019

Study Start

January 15, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations

BE(1)