Clinical trial NCT04304027: Exercise to Manage Fatigue in Progressive Multiple Sclerosis
Official title: Feasibility Evaluation of a Tailored Exercise Intervention to Manage Fatigue in Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Exercise
Fatigue
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention tolerance
timeFrame: Weeks 1-8
measure: Intervention adherence
timeFrame: Weeks 1-8
measure: Intervention acceptability
timeFrame: Week 8
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: Baseline, 8 weeks
measure: Modified Fatigue Impact Scale
timeFrame: Baseline, 8 weeks
measure: Aerobic capacity
timeFrame: Baseline, 8 weeks
measure: Multiple Sclerosis Impact Scale
timeFrame: Baseline, 8 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline, 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 8 weeks
measure: Symbol Digits Modalities Test
timeFrame: Baseline, 8 weeks
measure: Six Minute Walk Test
timeFrame: Baseline, 8 weeks
measure: Energy Cost of Walking
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Falkirk
country: United Kingdom
facility: Falkirk Community Hospital
Study officials:
affiliation: Glasgow Caledonian University
name: Scott Rooney, PhD
role: PRINCIPAL_INVESTIGATOR
References: