Exercise Booster Sessions in People With Multiple Sclerosis

December 19, 2024 updated by: University of Aarhus

Sustainability of Exercise Therapy by the Use of Exercise Booster Sessions in People With Multiple Sclerosis.

This study wants to investigate whether exercise booster sessions applied in the follow-up period after an exercise intervention can increase the sustainability of exercise induced effects in persons with multiple sclerosis.

The study will be a randomized, multi-site, controlled trial. Participants will from the beginning be allocated to either aerobic training group, resistance training group or control group. After a 12 week exercise intervention, the exercise groups will be additionally randomized to receive either exercise booster sessions + standard care or just standard care in the 40 week follow up period.

It is hypothesized that exercise booster sessions can increase the sustainability of exercise induced effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MS is a chronic, autoimmune, and inflammatory disease of the central nervous system, exemplified through marked demyelination and axonal loss. As a result, symptoms such as fatigue, numbness, weakness, depression, walking difficulties and spasticity frequently appear.

Although there is no cure for MS, several disease-modifying therapies are available. These can potentially slow the progression of disabilities and reduce the overall disease burden. This is of great interest from both an individual perspective, where increased disability is associated with a lowered health-related quality of life, and from a societal perspective, where increased disability is associated with larger costs.

Over the past decades exercise has been shown to be safe, tolerable and beneficial in persons with MS (PwMS). Hence, it is known to be an effective way of treating symptoms such as fatigue7, muscle weakness, walking impairments and depression. As with other chronic diseases, exercise for PwMS has been proposed as "medicine". However, in order to benefit from the positive effects of any kind of treatment (i.e. most medical drugs or exercise) one has to adhere to the prescriptions of the treatment (i.e. dose and timing). Despite all the potential benefits of exercise therapy for PwMS, one of the major challenges relate to long-term maintenance of exercise efforts.

An emerging concept that may hold the potential to increase the sustainability of exercise therapy is supervised "exercise booster sessions" (i.e. training sessions provided regularly throughout the follow-up period, to sustain effects of the preceding exercise intervention). These can be placed regularly during the follow-up period, where patients attend a number of supervised high-intensity exercise sessions, hereby trying to boost the effects of the preceding exercise intervention. Furthermore, exercise booster sessions can potentially motivate the patient to keep exercising throughout the follow up period.

However, the optimal way of utilizing this concept is still not fully understood, and has not yet been tried in neurological patients.

Therefore, the main purpose of the present study is to investigate how exercise booster sessions combined with usual care performed over a period of 40 weeks affects the sustainability of effects on functional capacity induced by a 12-week exercise intervention.

It is hypothesized that participants receiving exercise booster sessions + usual care during follow up will have a better functional capacity at follow up, than the participants receiving usual care only.

The study will be a randomized, multi-site, controlled trial. Participants will from the beginning be allocated to either aerobic training group, resistance training group or control group. After a 12 week exercise intervention, the exercise groups will be additionally randomized to receive either exercise booster sessions + standard care or just standard care in the 40 week follow up period.

The 12 week exercise intervention will consist of 2-3 weekly supervised exercise sessions. The training will be planned by exercise physiologists and performed in a progressive manner. To allow handling of a large number of participants, who is also geographically spread, the exercise intervention will be locally anchored, but at the same time supervised by student employees and controlled by internet- and telephonic communication.

Participants allocated to exercise booster sessions will receive two sessions every fifth week during the follow up period.

The power calculation is based on the primary purpose of the study which is to investigate the effect of frequently applied exercise booster sessions. To set the estimated number of participants, a two-sample two-sided power calculation has been conducted. Based on previous studies, a mean difference on functional capacity between the group receiving usual care and the group receiving exercise booster sessions + usual care, regardless of exercise intervention, is expected to be 6% with a standard deviation (SD) of ±10%.

The level of significance was set as 5% and a statistical power of 80%. According to the power calculation each group shall contain 60 participants (expected drop-out rate of 30 % is included).

The results of these studies can have great clinical implications in many ways. If we find that by adding exercise booster sessions in a follow up period, one can maintain, or maybe even improve, functional capacity over a long period, this would be a novel finding making ground for new rehabilitation opportunities

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A definite diagnosis of MS, according to the McDonald criteria
  • Walking <650m on 6MWT.
  • Exercising ≤ two sessions per week of moderate-to-high intensity during the past six months.

Exclusion Criteria:

  • Comprise comorbidities (cardiovascular-, respiratory-, orthopedic- or other neurological diseases.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic training booster group
Will receive 12 weeks of aerobic training followed by booster sessions + standard care in the 40 follow up period
Combination product: Systematic aerobic training
Two-three weekly supervised aerobic exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Combination product: Aerobic training booster sessions
Supervised aerobic training booster sessions delivered in the follow up period (two sessions every fifth week).
Active Comparator: Aerobic training control group
Will receive 12 weeks of aerobic training followed by standard care in the 40 follow up period
Combination product: Systematic aerobic training
Two-three weekly supervised aerobic exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Experimental: Resistance training booster group
Will receive 12 weeks of resistance training training followed by booster sessions + standard care in the 40 follow up period
Combination product: Systematic resistance training
Two-three weekly supervised resistance exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
Combination product: Resistance training booster sessions
Supervised resistance training booster sessions in the follow up period (two sessions every fifth week).
Active Comparator: Resistance training control group
Will receive 12 weeks of resistance training followed by standard care in the 40 follow up period
Combination product: Systematic resistance training
Two-three weekly supervised resistance exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
No Intervention: Control group
Will receive standard care throughout the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional capacity measured as a composite score of the six minute walk test and the 5x sit to stand test (5STS).
Time Frame: Baseline,12 weeks and 52 weeks.
The six minute walk test it the distance covered during a six-minute maximal walking test. The 5STS is the time used to stand up from a chair and sit again five times.
Baseline,12 weeks and 52 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional capacity measured by the Six spot step test (SSST)
Time Frame: Baseline, 12 weeks and 52 weeks.
SSST is a measure of walking ability, balance and coordination. Measured as the time to complete the six-spot course.
Baseline, 12 weeks and 52 weeks.
Change in functional capacity measured by the Multiple Sclerosis Functional Composite (MSFC)
Time Frame: Baseline, 12 weeks and 52 weeks.
Composite score from Timed 25-Feet Walk Test (T25FWT), 9-Hole Peg Test (9HPT), Paced Auditory Serial Addition Test (PASAT)
Baseline, 12 weeks and 52 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical activity, accelerometry
Time Frame: Baseline, 12 weeks and 52 weeks.
Measurement of level of physical activity by wearing a accelerometer for 7 days at each time point. Measured in counts/min.
Baseline, 12 weeks and 52 weeks.
Change in aerobic capacity
Time Frame: Baseline, 12 weeks and 52 weeks.
Maximal oxygen uptake test on bike ergometer, measured by indirect calorimetry.
Baseline, 12 weeks and 52 weeks.
Change in Multiple Sclerosis Walking Scale 12 (MSWS-12)
Time Frame: Baseline, 12 weeks and 52 weeks.
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.
Baseline, 12 weeks and 52 weeks.
Change in Modified Fatigue Impact Scale (MFIS)
Time Frame: Baseline, 12 weeks and 52 weeks.
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.
Baseline, 12 weeks and 52 weeks.
Change in Short Form Health Survey 36 (SF-36)
Time Frame: Baseline, 12 weeks and 52 weeks.
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.
Baseline, 12 weeks and 52 weeks.
Change in Hospital anxiety and depression scale (HADS)
Time Frame: Baseline, 12 weeks and 52 weeks.
Questionnaire assessing anxiety and depression. It consists of two subscales (anxiety and depression), and should be scored separately. A higher score indicates a higher degree of anxiety and depression.
Baseline, 12 weeks and 52 weeks.
Change in self reported physical activity measured by the Baecke questionnaire.
Time Frame: Baseline, 12 weeks and 52 weeks.
Questionnaire assessing the self reported amount of physical activity. This questionnaire quantifies the habitual physical activity level in three indexes: occupational (at work), sport (structured exercise) and leisure (leisure time). Each index is scored from 1 to 5, with 5 indicating the highest level of physical activity
Baseline, 12 weeks and 52 weeks.
Change in maximal strength
Time Frame: Baseline, 12 weeks and 52 weeks.
Maximal strength measurement measured in the knee extensors by isokinetic dynamometry.
Baseline, 12 weeks and 52 weeks.
Change in functional capacity measured by the Timed Up and Go
Time Frame: Baseline, 12 weeks and 52 weeks
The Timed up and Go is a test that evaluates functional components of mobility
Baseline, 12 weeks and 52 weeks
Change in cognition measured by the SDMT
Time Frame: Baseline, 12 weeks and 52 weeks.
The SDMT is a test measuring processing speed
Baseline, 12 weeks and 52 weeks.
Change in EQ-5D-5L
Time Frame: Baseline, 12 weeks and 52 weeks
The EQ-5D-5L measures health related quality of life, and is measured both by a VAS scale and an index score
Baseline, 12 weeks and 52 weeks
Change in societal costs measured by the HUQ
Time Frame: Baseline, 12 weeks and 52 weeks.
The HUQ measures health utilization by assessing healthcare and medicine usage, and productivity.
Baseline, 12 weeks and 52 weeks.
Change in societal costs measured by the IPCQ.
Time Frame: Baseline, 12 weeks and 52 weeks.
The IPCQ measures health utilization by assessing healthcare and medicine usage, and productivity.
Baseline, 12 weeks and 52 weeks.
Change in falls and fear of falling by the Falls Efficacy Scale
Time Frame: Baseline, 12 weeks and 52 weeks.
The Falls Efficacy scale measures the concern participants have of falling
Baseline, 12 weeks and 52 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Oxford Brookes University

Investigators

  • Principal Investigator: Laurits Taul-Madsen, MSc., University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

October 4, 2024

Study Completion (Actual)

October 4, 2024

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Laurits_Madsen_PhD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be stored in The Danish National Archives after completion of the project, and data can be accessed through request to The Danish National Archives.

IPD Sharing Time Frame

The data will become available after completion of the project, expectedly May 2024. The Danish National Archives stores data without a time frame (forever).

IPD Sharing Access Criteria

Sharing of data can happen upon request to The Danish National Archives.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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