Multiple Sclerosis Clinical Trial
Official title:
Feasibility Evaluation of a Tailored Exercise Intervention to Manage Fatigue in Progressive Multiple Sclerosis
NCT number | NCT04304027 |
Other study ID # | 19/WS/0140 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 10, 2019 |
Est. completion date | June 2020 |
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 fatigue - especially in people with progressive MS. Therefore, this study aims to test the feasibility of a tailored exercise programme to help improve fatigue in people with progressive MS. To do this people with progressive MS who are experiencing fatigue will be randomly allocated to receive either a tailored exercise programme, a standard exercise programme, or their usual care. Both exercise programmes will be 8 weeks long and require participants to attend Falkirk Community Hospital twice a week. The standard exercise programme involves a moderate intensity interval training session using a stationary exercise bike. The tailored exercise programme is similar to the standard exercise programme, as participants will be prescribed the same type and duration of exercise; however, the difference between the 2 programmes is that the intensity of exercise performed during each session of the tailored exercise programme is dictated by the participant's level of fatigue. Participants will complete an exercise test, walking test, and questionnaires relating to fatigue, quality of life, depression and anxiety, sleep quality, and cognition before and 1 week after completing the exercise programme.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | June 2020 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Falkirk Community Hospital | Falkirk |
Lead Sponsor | Collaborator |
---|---|
Glasgow Caledonian University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intervention tolerance | Participants will record the severity of fatigue before and for 48-hours following each exercise session using a Numerical Rating Scale | Weeks 1-8 | |
Primary | Intervention adherence | 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 | Weeks 1-8 | |
Primary | Intervention acceptability | 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 | Fatigue Severity Scale | Self-reported questionnaire measuring the severity of fatigue | Baseline, 8 weeks | |
Secondary | Modified Fatigue Impact Scale | Self-reported questionnaire measuring the impact of fatigue on physical, cognitive, and psychosocial function | Baseline, 8 weeks | |
Secondary | Aerobic capacity | Aerobic capacity estimated using the YMCA sub-maximal bicycle ergometer test | Baseline, 8 weeks | |
Secondary | Multiple Sclerosis Impact Scale | Self-reported questionnaire measuring the physical and psychological impact of Multiple Sclerosis | Baseline, 8 weeks | |
Secondary | Hospital Anxiety and Depression Scale | Self-reported questionnaire measuring the severity of anxiety and depression | Baseline, 8 weeks | |
Secondary | Pittsburgh Sleep Quality Index | Self-reported questionnaire measuring sleep quality | Baseline, 8 weeks | |
Secondary | Symbol Digits Modalities Test | Cognitive screening tool which measures processing speed | Baseline, 8 weeks | |
Secondary | Six Minute Walk Test | Measurement of the maximum walking distance covered during 6 minutes | Baseline, 8 weeks | |
Secondary | Energy Cost of Walking | Estimation of oxygen consumption per meter walked during the six minute walk test measured using Cosmed K4 portable oxygen telemetry system | Baseline, 8 weeks |
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