Exercise to Manage Fatigue in Progressive Multiple Sclerosis
NCT ID: NCT04304027
Last Updated: 2020-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
45 participants
INTERVENTIONAL
2019-12-10
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of a One-year Group Program for Fatigue Management in Minimally Impaired People With Multiple Sclerosis
NCT07028879
Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis
NCT06201026
High-intensity Resistance Training in People With Multiple Sclerosis Experiencing Fatigue
NCT04562376
Cardiovascular Fitness of Patients With Multiple Sclerosis, Effect of Exercise on Fatigue and Depression
NCT05671588
Transient and Immediate Motor Effects of Exercise in Progressive Multiple Sclerosis
NCT05562414
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tailored exercise intervention
8 weeks of aerobic interval training at moderate intensity which is modified according to the levels of self-reported fatigue
Tailored exercise intervention
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)
Standard exercise intervention
8 weeks of aerobic interval training at a moderate intensity
Standard exercise intervention
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
Usual care control
Participants in the usual care control group will continue to receive their standard care independent of this study
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tailored exercise intervention
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)
Standard exercise intervention
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Glasgow Caledonian University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Scott Rooney, PhD
Role: PRINCIPAL_INVESTIGATOR
Glasgow Caledonian University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Falkirk Community Hospital
Falkirk, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
19/WS/0140
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.