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

Multiple Sclerosis Clinical Trial

Official title:

High-intensity Resistance Training in People With Multiple Sclerosis Experiencing Fatigue - Effects on Functioning, Wellbeing and Inflammatory Biological Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562376
• Other study ID #: FOR 4-2358/2020
• Status: Completed
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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). 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. All participants will after the end of intervention be offered a prescription of physical activity (FaR), and have the opportunity for follow-up telephone calls at 3-, 6- and 12 months after the end of the intervention. Assessment of fatigue will also be performed at these follow-up telephone sessions. Fatigue assessments from a natural history cohort (Combat study) will be available for comparisons of natural fluctuations of fatigue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 30, 2022
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

Other:
• High-intensity resistance training
The program consists of high-intensity resistance training for 60 minutes twice a week (group A) during 12 weeks
• Low frequency of high-intensity resistance training
The program consists of high-intensity resistance training for 60 minutes once a week (group B) during 12 week

Locations

Country	Name	City	State
Sweden	Academic Specialist Center, , Stockholm Health Services, Region Stockholm	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Neuro+

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fatigue Severity Scale	Fatigue measured with the FSS, minimum value 1, maximum value 7, higher scores mean a worse outcome	Directly after intervention
Secondary	Hospital Anxiety and Depression Scale	Mood measured with HADS, Anxiety and depression subscales, minimum value 0, maximum value 21, higher scores mean a worse outcome	Directly after the intervention
Secondary	Occupational Gaps Questionnaire	Participation in everyday occupations measured with the OGQ, minimum value 0, maximum value 30, higher scores mean a worse outcome	Directly after the intervention
Secondary	Multiple Sclerosis Impact Scale-29	Health-related quality of life/impact of MS measured with the MS Impact Scale-29, Physical and psychological subscales, minimum value 0, maximum value 100, higher scores mean a worse outcome	Directly after the intervention
Secondary	Euroqool five dimension five level	Wellbeing/health-related quality of life measured with the EQ-5D-5L, minimum value 0, maximum value 1, higher scores mean a better outcome	Directly after the intervention
Secondary	Euroqool visual analogue scale	Wellbeing/health-related quality of life measured with the EQ VAS, minimum value 0, maximum value 100, higher scores mean a better outcome	Directly after the intervention
Secondary	Multiplex proteomic immunoassay and enzyme-linked immunosorbent assay	Analyses of inflammatory biological markers (cytokines) in blood will be analysed, a minimum and maximum value can not be specified, and higher or lower values will have different meaning depending on which biological marker (cytokine)	Directly after the intervention