Multiple SclerosisNCT04562376
High-intensity Resistance Training in People With Multiple Sclerosis Experiencing Fatigue
A study testing High-intensity resistance training and Low frequency of high-intensity resistance training in people with Multiple Sclerosis and Fatigue, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Fatigue, Exercise Therapy
- What is being tested?
- High-intensity resistance training and Low frequency of high-intensity resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSweden
- Study dates
- 20 Aug 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Other conditions or diagnoses judged to potentially interfere with the trial.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Academic Specialist Center, , Stockholm Health Services, Region Stockholm
Stockholm, 11365
About this study
Official title: High-intensity Resistance Training in People With Multiple Sclerosis Experiencing Fatigue - Effects on Functioning, Wellbeing and Inflammatory Biological Markers
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
Read the detailed 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.
- Conditions
- Multiple Sclerosis, Fatigue, Exercise Therapy, Resistance Training, Cytokines
- Being tested
- High-intensity resistance training, Low frequency of high-intensity resistance training
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity resistance trainingOther
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 trainingOther
The program consists of high-intensity resistance training for 60 minutes once a week (group B) during 12 week
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Low frequency of high-intensity resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Scale for Motor and Cognitive Functions
Fatigue measured with the FSMC, minimum value 20, maximum value 100, higher scores mean a worse outcome
Measured: Directly after the intervention (ie change from assessments at baseline to follow-up after the 12 week intervention)
Secondary outcomes (7)
Fatigue Severity Scale
Fatigue measured with the FSS, minimum value 1, maximum value 7, higher scores mean a worse outcome
Measured: Directly after intervention
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
Measured: Directly after the intervention
Occupational Gaps Questionnaire
Participation in everyday occupations measured with the OGQ, minimum value 0, maximum value 30, higher scores mean a worse outcome
Measured: Directly after the intervention
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
Measured: Directly after the intervention
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
Measured: Directly after the intervention
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
Measured: Directly after the intervention
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)
Measured: Directly after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start20 Aug 2020
- Primary completion28 Jun 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Neuro+
- Responsible party
- Principal investigator, Marie Kierkegaard, Karolinska Institutet
- Investigators
- Marie Kierkegaard, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562376
- Sponsor's protocol ID
- FOR 4-2358/2020
- Status last verified
- Aug 2022
- First submitted
- 18 Sep 2020
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results in a publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Resistance Training in People With Multiple Sclerosis Experiencing Fatigue - Effects on Functioning, Wellbeing and Inflammatory Biological Markers
- ClinicalTrials.gov ID
- NCT04562376
- Acronym / sponsor ID
- FOR 4-2358/2020
- Conditions
- Multiple Sclerosis, Fatigue, Exercise Therapy, Resistance Training, Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Neuro+
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: High-intensity resistance trainingThe 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. |
| Group B | Active comparator | Other: Low frequency of high-intensity resistance trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Other conditions or diagnoses judged to potentially interfere with the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity resistance trainingThe program consists of high-intensity resistance training for 60 minutes twice a week (group A) during 12 weeks | Other | Group A |
| Low frequency of high-intensity resistance trainingThe program consists of high-intensity resistance training for 60 minutes once a week (group B) during 12 week | Other | Group B |
Primary outcome
Fatigue Scale for Motor and Cognitive Functions
Time frame: Directly after the intervention (ie change from assessments at baseline to follow-up after the 12 week intervention)
Fatigue measured with the FSMC, minimum value 20, maximum value 100, higher scores mean a worse outcome
7 secondary outcomes
Fatigue Severity Scale
Time frame: Directly after intervention
Hospital Anxiety and Depression Scale
Time frame: Directly after the intervention
Occupational Gaps Questionnaire
Time frame: Directly after the intervention
Multiple Sclerosis Impact Scale-29
Time frame: Directly after the intervention
Euroqool five dimension five level
Time frame: Directly after the intervention
Euroqool visual analogue scale
Time frame: Directly after the intervention
Multiplex proteomic immunoassay and enzyme-linked immunosorbent assay
Time frame: Directly after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results in a publication, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Kierkegaard, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity resistance training and Low frequency of high-intensity resistance training in people with Multiple Sclerosis and Fatigue, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Scale for Motor and Cognitive Functions (time frame: Directly after the intervention (ie change from assessments at baseline to follow-up after the 12 week intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.