- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04304027
Exercise to Manage Fatigue in Progressive Multiple Sclerosis
Feasibility Evaluation of a Tailored Exercise Intervention to Manage Fatigue in Progressive Multiple Sclerosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to evaluate the feasibility of delivering a tailored exercise intervention to manage fatigue in people with progressive forms of MS. To do this, a randomised controlled trial design will be used to assess the feasibility of delivering a tailored exercise intervention to manage fatigue in people with progressive forms of MS in comparison to a standard (untailored) exercise group and usual care control group.
This study aims to recruit up to 45 people with progressive MS who are experiencing moderate-severe levels of fatigue from MS clinics and outpatient physiotherapy services within NHS Forth Valley. Participants will be randomly allocated to receive either the tailored exercise programme, the standard exercise programme, or their usual care. All outcome measures will be recorded at baseline and post-intervention.
Both exercise programmes will require participants to attend Falkirk Community Hospital twice a week for 8 weeks - therefore, participants will receive 16 exercise sessions in total. All exercise sessions will be supervised by a physiotherapist and they will provide participants with any support that is required. The standard exercise programme involves aerobic-based interval training delivered on a bicycle ergometer. Each exercise session will be 30 minutes in duration, and will be broken down into a 3 minute warm-up, 24 minutes of interval training, and a 3 minute cool-down. During the interval training component, participants will be asked to perform 6 intervals that require them to exercise at a moderate intensity (>70% heart rate reserve) for 2 minutes followed by 2 minutes of recovery.
The tailored exercise programme is similar to the standard exercise programme - participants will still be required to attend Falkirk Community Hospital twice a week for 8 weeks, and they will perform the same type and duration of exercise as the standard exercise programme. However in order to tailor exercise to fatigue, participants will be asked to rate their current levels of fatigue before exercising - this rating will then be compared to the baseline score. If the participant's fatigue is worse, they will be offered the option of performing a lower intensity of exercise for that specific session (>50% heart rate reserve). In addition, participants will also be asked to monitor their fatigue in a symptom diary for 2 days following each exercise session. If fatigue is worsened by exercise and remains elevated for 2 days after 2 consecutive exercise sessions, then they will also be offered the option of performing the lower intensity exercise prescription.
Participants in the usual care control group will continue to receive their standard care independent of this study. Participants will also receive an information booklet about fatigue that is freely available from the UK MS Society. This booklet provides general information about MS-related fatigue, strategies to self-monitor and self-manage symptoms, and directs them to contact health professionals involved in their care for support if required.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Scott Rooney
- Phone Number: 0141 273 1695
- Email: scott.rooney@gcu.ac.uk
Study Contact Backup
- Name: Lorna Paul
- Phone Number: +44 1413318108
- Email: Lorna.Paul@gcu.ac.uk
Study Locations
-
-
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Falkirk, United Kingdom, FK1 5QE
- Recruiting
- Falkirk Community Hospital
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Contact:
- Scott Rooney
- Phone Number: 0141 273 1695
- Email: scott.rooney@gcu.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Neurologist-confirmed diagnosis of MS and a progressive form of the disease (either secondary or primary progressive)
- Self-report of moderate-severe fatigue in the last 7 days at screening by indicating that their fatigue is six or more when answering the following "have you had fatigue in the last seven days: between 0 (no fatigue) and 10 (extremely fatigued).
- Moderate level of disability to allow for participants to use the bicycle ergometer (indicated by an Expanded Disability Status Scale score of between ≥4 and ≤6.5)
- Be willing and able to attend Falkirk Community Hospital, twice a week for 8 consecutive weeks to receive the intervention.
Exclusion Criteria:
- A neurologist confirmed relapse of MS within the past three months
- Commenced or had a change in MS disease modifying treatment within the past six months
- Unable to provide informed consent
- Concurrently participating in another intervention trial
- Diagnosed with any of the following conditions which may also cause high levels of fatigue: anaemia, inflammatory rheumatic disease, hypothyroidism, cancer
- Cardiovascular event in the past year including but not limited to: myocardial infarction, transient ischaemic attack or cerebrovascular accident
- Diagnosis of cardiovascular, respiratory, or metabolic disease that would prevent participants from safely performing exercise including but not limited to: angina, heart failure, uncontrolled hypertension, peripheral vascular disease, chronic obstructive pulmonary disease, diabetes mellitus
- Prescription of the following medication: beta blockers, vasodilators, ACE inhibitors, diuretics or any other medication that may cause exercise induced hypotension
- Significant co-morbidity such as significant musculoskeletal or neurological conditions other than MS
Study Plan
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: Tailored exercise intervention
8 weeks of aerobic interval training at moderate intensity which is modified according to the levels of self-reported fatigue
|
2x 30 minute aerobic interval training per week for 8 weeks - sessions involve 6 intervals cycling for 2 minutes at target heart rate reserve followed by 2 minutes working rest (target heart rate reserve may vary between sessions depending on the level of self-reported fatigue)
|
Active Comparator: Standard exercise intervention
8 weeks of aerobic interval training at a moderate intensity
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2x 30 minute aerobic interval training per week for 8 weeks - sessions involve 6 intervals cycling for 2 minutes at >70% heart rate reserve followed by 2 minutes working rest
|
No Intervention: Usual care control
Participants in the usual care control group will continue to receive their standard care independent of this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention tolerance
Time Frame: Weeks 1-8
|
Participants will record the severity of fatigue before and for 48-hours following each exercise session using a Numerical Rating Scale
|
Weeks 1-8
|
Intervention adherence
Time Frame: Weeks 1-8
|
Adherence will be determined by recording the proportion of exercise sessions that each participant attends, whether the participant completes the prescribed exercise duration during each session, and whether the participant is able to reach and maintain the prescribed target heart rate
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Weeks 1-8
|
Intervention acceptability
Time Frame: Week 8
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The participants' views of the study procedures will be explored using an online survey.
The survey contains questions relating to the content of the exercise/control groups, relevance of outcome measures included, the perceived positive/negatives of the intervention, and ways to improve the study design
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue Severity Scale
Time Frame: Baseline, 8 weeks
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Self-reported questionnaire measuring the severity of fatigue
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Baseline, 8 weeks
|
Modified Fatigue Impact Scale
Time Frame: Baseline, 8 weeks
|
Self-reported questionnaire measuring the impact of fatigue on physical, cognitive, and psychosocial function
|
Baseline, 8 weeks
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Aerobic capacity
Time Frame: Baseline, 8 weeks
|
Aerobic capacity estimated using the YMCA sub-maximal bicycle ergometer test
|
Baseline, 8 weeks
|
Multiple Sclerosis Impact Scale
Time Frame: Baseline, 8 weeks
|
Self-reported questionnaire measuring the physical and psychological impact of Multiple Sclerosis
|
Baseline, 8 weeks
|
Hospital Anxiety and Depression Scale
Time Frame: Baseline, 8 weeks
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Self-reported questionnaire measuring the severity of anxiety and depression
|
Baseline, 8 weeks
|
Pittsburgh Sleep Quality Index
Time Frame: Baseline, 8 weeks
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Self-reported questionnaire measuring sleep quality
|
Baseline, 8 weeks
|
Symbol Digits Modalities Test
Time Frame: Baseline, 8 weeks
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Cognitive screening tool which measures processing speed
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Baseline, 8 weeks
|
Six Minute Walk Test
Time Frame: Baseline, 8 weeks
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Measurement of the maximum walking distance covered during 6 minutes
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Baseline, 8 weeks
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Energy Cost of Walking
Time Frame: Baseline, 8 weeks
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Estimation of oxygen consumption per meter walked during the six minute walk test measured using Cosmed K4 portable oxygen telemetry system
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Baseline, 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott Rooney, PhD, Glasgow Caledonian University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19/WS/0140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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