High-intensity Resistance Training in People With Multiple Sclerosis Experiencing Fatigue

NCT04562376 | Completed DMC

• 1 other identifier: FOR 4-2358/2020
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Fatigue is one of the most frequently reported and disabling impairments in multiple sclerosis (MS) and is associated with activity limitations, participation restrictions and reduced health-related quality of life (HRQL).MS fatigue is thought to be related to the disease itself, where increased levels of inflammatory biological markers (cytokines) are contributing. Resistance training may have an anti-inflammatory effect where a higher intensity is thought to have a more profound effect. Moderate-intensity resistance training is well tolerated in people with MS (PwMS) and can reduce self-reported fatigue. There is, however, a lack of high-quality studies including only fatigued PwMS when evaluating exercise regimes. Furthermore, the optimal dose (i.e. the combination of duration, frequency and intensity) is not known. Our hypothesis is that high-intensity resistance training will have positive effects in fatigued PwMS on functioning (fatigue, mood, activities and participation) and wellbeing/HRQL; and a positive immunomodulatory effect measured by inflammatory biological markers in blood. Further, that high-intensity resistance training twice a week will be superior to once a week

Conditions

Multiple Sclerosis; Fatigue; Exercise Therapy; Resistance Training; Cytokines

Outcome Measures

Primary Outcomes (1)

• Fatigue Scale for Motor and Cognitive Functions

  Fatigue measured with the FSMC, minimum value 20, maximum value 100, higher scores mean a worse outcome

  Directly after the intervention (ie change from assessments at baseline to follow-up after the 12 week intervention)

Secondary Outcomes (7)

• Fatigue Severity Scale

  Directly after intervention

• Hospital Anxiety and Depression Scale

  Directly after the intervention

• Occupational Gaps Questionnaire

  Directly after the intervention

• Multiple Sclerosis Impact Scale-29

  Directly after the intervention

• Euroqool five dimension five level

  Directly after the intervention

Study Arms (2)

Group A

EXPERIMENTAL

The program consists of high-intensity resistance training for 60 minutes twice a week for group A during 12 weeks at the Karolinska University Hospital under the supervision of a physiotherapist. Participants in group A will have different possible training alternatives every week to ensure availability, and they will train in groups of three to five persons/session.

Other: High-intensity resistance training

Group B

ACTIVE COMPARATOR

The program consists of high-intensity resistance training for 60 minutes once a week for group B during 12 weeks at the Karolinska University Hospital under the supervision of a physiotherapist. Participants in group B will have different possible training alternatives every week to ensure availability, and they will train in groups of three to five persons/session.

Other: Low frequency of high-intensity resistance training

Interventions

High-intensity resistance training OTHER

The program consists of high-intensity resistance training for 60 minutes twice a week (group A) during 12 weeks

Group A

Low frequency of high-intensity resistance training OTHER

The program consists of high-intensity resistance training for 60 minutes once a week (group B) during 12 week

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults older than 18 years with the diagnosis MS according to the revised McDonald Criteria, having fatigue (i.e. ≥ 53 FSMC sum score), able to understand and communicate in Swedish, and not practicing high-intensity training within 6 months prior to the trial.

You may not qualify if:

• Other conditions or diagnoses judged to potentially interfere with the trial.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Neuro+: collaborator

Study Sites (1)

Academic Specialist Center, , Stockholm Health Services, Region Stockholm

Stockholm, 11365, Sweden

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie Kierkegaard, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A person with no further involvement in the study will manage the randomization. A research assistant will assign participants with an identification number which will be used during baseline and follow-up assessments to ensure blinding of the assessors. Thus, outcome assessors are blinded for group allocation. Data entry will be executed by a person blinded for group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Docent)

Model Details: This is a two-armed single-blinded randomized controlled trial of high-intensity resistance training in PwMS with fatigue where one group receive training twice a week (group A) and the other group once a week (group B). The randomization procedure will be performed after baseline assessments and will be concealed and based on computer-generated block randomization with block sizes of ten. No stratification will be used. Implementation of the random allocation will be done by means of sequentially numbered sealed opaque envelops.

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: August 20, 2020
• Primary Completion: June 28, 2021
• Study Completion: June 30, 2022
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Immediately following publication and ending 2 years after publication
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve the aims in the approved proposal. Proposals should be directed to marie.kierkegaard@ki.se

Locations

SE (1)