Exercise to Manage Fatigue in Progressive Multiple Sclerosis

NCT04304027 | Unknown

• 1 other identifier: 19/WS/0140
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Exercise; Fatigue

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (9)

• Fatigue Severity Scale

  Baseline, 8 weeks

• Modified Fatigue Impact Scale

  Baseline, 8 weeks

• Aerobic capacity

  Baseline, 8 weeks

• Multiple Sclerosis Impact Scale

  Baseline, 8 weeks

• Hospital Anxiety and Depression Scale

  Baseline, 8 weeks

Study Arms (3)

Tailored exercise intervention

EXPERIMENTAL

8 weeks of aerobic interval training at moderate intensity which is modified according to the levels of self-reported fatigue

Other: Tailored exercise intervention

Standard exercise intervention

ACTIVE COMPARATOR

8 weeks of aerobic interval training at a moderate intensity

Other: Standard exercise intervention

Usual care control

NO INTERVENTION

Participants in the usual care control group will continue to receive their standard care independent of this study

Interventions

Tailored exercise intervention OTHER

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)

Tailored exercise intervention

Standard exercise intervention OTHER

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

Standard exercise intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Glasgow Caledonian University: lead

Study Sites (1)

Falkirk Community Hospital

Falkirk, FK1 5QE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott Rooney, PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Rooney

CONTACT

0141 273 1695; scott.rooney@gcu.ac.uk

Lorna Paul

CONTACT

+44 1413318108; Lorna.Paul@gcu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: December 10, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)