Status:
UNKNOWN
Exercise to Manage Fatigue in Progressive Multiple Sclerosis
Lead Sponsor:
Glasgow Caledonian University
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fatigue is one of the most common and debilitating symptoms of Multiple Sclerosis (MS). Exercise is suggested as a way to improve fatigue, but it is not clear what the effects of exercise are on fatig...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04304027
Start Date
December 10 2019
End Date
June 1 2020
Last Update
March 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Falkirk Community Hospital
Falkirk, United Kingdom, FK1 5QE