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Early Exercise Efforts in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03322761
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
University of Southern Denmark
Region of Southern Denmark
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

This study seeks to investigate whether early exercise efforts can expand the use of exercise in Multiple sclerosis (MS), from symptom treatment only, to early supplementary disease-modifying treatment.

The study will be conducted in a randomized and controlled manner, with single blinding. Participants will be allocated to either a systematic aerobic exercise intervention or an educational programme on exercise and physical activity. Both interventions will last 1 year, and involve a 1 year follow-up period.

It is hypothesized that early exercise efforts can modify the disease activity and disability progression.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Combination Product: Systematic exercise training Behavioral: Educational program Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise as a Supplemental Treatment Strategy Early in the Disease Course of Multiple Sclerosis
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Systematic exercise training
Two weekly supervised aerobic exercise trainings for 48 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Combination Product: Systematic exercise training
Combination of standard medical treatment and systematic early exercise training in persons with MS.

Active Comparator: Educational program
Educational program on physical activity and health, consisting of four educational sessions in the intervention period.
Behavioral: Educational program
Informations regarding health benefits of physical activity and exercise.

No Intervention: Standard treatment alone
Data from The Danish MS Registry will serve as control-data for standard treatment alone.



Primary Outcome Measures :
  1. Change in Annual Relapse Rate (ARR) [ Time Frame: ARR, 1 year intervention; 1 year follow up. ]
    Number of relapses, registered and validated by neurologist, on annual basis

  2. Percentage brain volume change [ Time Frame: Baseline, after 1 year intervention, and again at 1 year follow up. ]
    Brain atrophy will be measured from MRI-scans


Secondary Outcome Measures :
  1. Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up. ]
    Composite score from Timed 25-Feet Walk Test (T25FWT), 9-Hole Peg Test (9HPT), Paced Auditory Serial Addition Test (PASAT)

  2. Expanded Disability Status Scale (EDSS) score [ Time Frame: Baseline, after 1 year intervention, and again at 1 year follow up. ]
    Disability status score assessed and registered by neurologist. The scale ranges from 0-10 in 0.5 unit increments representing higher levels of disability.


Other Outcome Measures:
  1. Functional capacity, Six-minute walk test (6MWT) [ Time Frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up. ]
    Distance covered during a six-minute maximal walking test

  2. Functional capacity, Six-spot-step-test (SSST) [ Time Frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up. ]
    SSSt is a measure of walking ability, balance and coordination. Measured as the time to complete the six-spot course.

  3. Functional capacity, Accelerometry [ Time Frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up. ]
    Measurement of level of physical activity by wearing a accelerometer for 7 days at each timepoint. Measured in counts/min.

  4. Cognition, Symbol Digit Modality Test (SDMT) [ Time Frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up. ]
    Assessment of cognitive function, with a higher number of correct answers in the test representing better cognitive function.

  5. Short Form Health Survey 36 (SF-36) [ Time Frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up. ]
    Questionnaire assessing health status. The SF-36 consists of eight subscales, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

  6. Multiple Sclerosis Impact Scale 29 (MSIS-29) [ Time Frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up. ]
    Questionnaire assessing the impact of the disease. 20 questions measure the physical impact, and 9 questions measure the psychological impact. Each question is scored from 1-5. A greater score is equal to a larger impact.

  7. Multiple Sclerosis Walking Scale 12 (MSWS-12) [ Time Frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up. ]
    Questionnaire assessing the impact of the disease on walking. Each question is scored from 1-5 and then summed and transformed to a 0-100 scale. Higher scores indicate a greater impact on walking.

  8. Modified Fatigue Impact Scale (MFIS) [ Time Frame: Baseline, 24 weeks, after 1 year intervention, and again at 1 year follow up. ]
    Questionnaire assessing the effects of fatigue on physical, cognitive and psychosocial functioning. The score of the MFIS is the sum of the scores for the 21 items. A higher score represents a higher impact of fatigue, in general or in relation to one of the above mentioned areas.

  9. Inflammation [ Time Frame: Baseline, after 1 year intervention, and again at 1 year follow up. ]
    Blood samples will be analyzed for key inflammatory cytokines

  10. Number of lesions [ Time Frame: Baseline, after 1 year intervention, and again at 1 year follow up. ]
    Number of lesions, measured by MRI-scanning.

  11. Lesion load [ Time Frame: Baseline, after 1 year intervention, and again at 1 year follow up. ]
    Volume of lesions, measured by MRI-scanning.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed consent
  • Definite diagnosis with Relapsing remitting multiple sclerosis (RRMS)
  • No more than 2 years since diagnosis
  • Expectedly able to carry out high intensity aerobic training
  • Able to transport themselves to and from training sessions

Exclusion Criteria:

  • Pregnancy
  • Dementia, alcohol abuse, or pacemaker
  • Metallic implants, hindering MRI-scans
  • Comorbidities hindering participation in high intensity aerobic training

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): NCT03322761


Contacts
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Contact: Morten Riemenschneider, MSc +4522855185 mori@ph.au.dk
Contact: Ulrik Dalgas, PhD +4540123039 dalgas@ph.au.dk

Locations
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Denmark
Section for Sport Science, Department of Public Health, University of Aarhus Recruiting
Aarhus, Denmark, 8000
Contact: Morten Riemenschneider, M.Sc.    +4522855185    mori@ph.au.dk   
Contact: Ulrik Dalgas, PhD.    +4540123039    dalgas@ph.au.dk   
Sponsors and Collaborators
University of Aarhus
University of Southern Denmark
Region of Southern Denmark
Investigators
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Principal Investigator: Morten Riemenschneider, MSc Section for Sport Science, Department of Public Health, Aarhus University

Publications:
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03322761     History of Changes
Other Study ID Numbers: Morten_Riemenschneider_PhD
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 University of Aarhus:
Multiple sclerosis
Exercise
Disease-modifying treatment
Early treatment
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases