High-intensity Resistance Training in People With Multiple Sclerosis Experiencing Fatigue
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cytokines
- Exercise Therapy
- Fatigue
- Multiple Sclerosis
- Resistance Training
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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.Masking: Single (Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Multiple sclerosis (MS) is chronic inflammatory neurodegenerative disease. About two-thirds of persons with MS (PwMS) report MS-related fatigue. It is a most disabling impairment and is associated with activity limitations, participation restrictions and reduced health-related quality of life (HRQL)...
Multiple sclerosis (MS) is chronic inflammatory neurodegenerative disease. About two-thirds of persons with MS (PwMS) report MS-related fatigue. It is a most disabling impairment and is associated with activity limitations, participation restrictions and reduced health-related quality of life (HRQL). MS fatigue may be related directly to the disease, e.g. inflammation. Resistance training can have direct effects on the MS disease by modulating cytokine levels, where a higher intensity is thought to have a more profound effect. Thus, there are reasons to hypothesise that high-intensity resistance training might reduce fatigue in PwMS. There are, however, no randomized controlled trials (RCTs) on resistance training in PwMS with fatigue. Although the recommendation of resistance training for adults with chronic diseases is twice a week, most primary health-care providers in Sweden only offer supervised training once a week for a limited period, e.g. 8-12 weeks. Thus, our aims are to evaluate the effects of 12 weeks high-intensity resistance training on functioning (fatigue, mood, activities and participation), wellbeing/HRQL and on inflammatory biological markers (e.g. cytokines) in blood. In this two-armed single-blinded RCT, 90 PwMS with fatigue will be recruited and randomly assigned to receive high-intensity resistance training under the supervision from a physiotherapist twice a week (group A) or once a week (group B). Primary outcome is fatigue measured with a patient reported outcome, i.e. the Fatigue Scale for Motor and Cognitive Functions (FSMC), and a change-score of ten points is considered clinically meaningful. Secondary outcomes include measures of mood, participation, self-perceived impact of MS, wellbeing/HRQL and inflammatory biological markers in blood. Data will be collected at baseline and within a week after the last training session of the 12-week intervention.
Tracking Information
- NCT #
- NCT04562376
- Collaborators
- Neuro+
- Investigators
- Principal Investigator: Marie Kierkegaard, PhD Karolinska Institutet
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