Exercise to Manage Fatigue in Progressive Multiple Sclerosis

Feasibility Evaluation of a Tailored Exercise Intervention to Manage Fatigue in Progressive Multiple Sclerosis

Status unknownNot a drug-phase studyProgressive MSNCT04304027

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Tailored exercise intervention

Compared with

  • Standard exercise intervention

What it measured

Main measures

  • Intervention tolerance

    Weeks 1-8

    FatiguePhysical function

  • Intervention adherence

    Weeks 1-8

    Physical functionQuality of life (reported by participants)

  • Intervention acceptability

    Week 8

    Physical functionFeasibility

Other measures (9)

  • Fatigue Severity Scale

    Baseline, 8 weeks

    Fatigue

  • Modified Fatigue Impact Scale

    Baseline, 8 weeks

    Thinking and memoryFatigue

  • Aerobic capacity

    Baseline, 8 weeks

    Physical function

  • Multiple Sclerosis Impact Scale

    Baseline, 8 weeks

  • Hospital Anxiety and Depression Scale

    Baseline, 8 weeks

    Mood and sleep

  • Pittsburgh Sleep Quality Index

    Baseline, 8 weeks

    Mood and sleep

  • Symbol Digits Modalities Test

    Baseline, 8 weeks

    Thinking and memory

  • Six Minute Walk Test

    Baseline, 8 weeks

    Walking and mobility

  • Energy Cost of Walking

    Baseline, 8 weeks

    Walking and mobility

Who could take part

Progressive MS · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Dec 2019

    2. Main results due

      Jun 2020

    3. Finished

      Jun 2020

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