Telephone-Delivered Exercise for Multiple Sclerosis Fatigue

Not Applicable

Completed

• Conditions: Physical Activity; Multiple Sclerosis; Fatigue

• Registration Number: NCT03256851
• Lead Sponsor: Wayne State University

Brief Summary

Multiple sclerosis (MS) is a progressive demyelinating disorder that damages white matter in the central nervous system. Although individuals experience mobility (e.g., walking, balance) impairments that lower quality of life and limit participation in daily activities, one of the most prominent symptoms is fatigue. Up to 92% of individuals report fatigue that manifests as lack of energy, exhaustion or worsening of MS symptoms and ultimately contributes to increasing disability. The currently available pharmaceutical treatments fail to fully control fatigue in the majority of individuals with MS; non-pharmacologic therapies such as exercise and behavioral therapies offer the best hope for combating MS fatigue in the majority of individuals.

Exercise therapy is effective in reducing MS fatigue. However, access to exercise therapy is seriously limited for many individuals with MS due to geographical location, limited resources (e.g., financial, transportation), and/or disability. Thus, the development and evaluation of an alternative delivery method for exercise therapy to target MS-related fatigue that increases participation and reduces barriers is critical.

In this study, the investigators will compare traditional in-person delivered exercise therapy to telephone-delivered exercise therapy to target fatigue in persons with MS.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Primary Completion: 2018-05-31
• Study Completion: 2018-07-31
• Results First Submitted: 2019-09-11
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-07
• Last Update Submitted: 2019-10-07
• Results First Posted: 2019-10-30
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of RRMS, SPMS, or PPMS
• Ambulatory for at least 5 minutes at a time
• Self-reported fatigue on Fatigue Severity Scale
• Able to follow study-related commands
• Able to attend study appointments

Exclusion Criteria

• MS exacerbation within the past 30 days
• Evidence of another neurological disorder or orthopedic disorder that would interfere with exercise participation
• Acute illness or injury that prevents participation in the intervention
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Daily Average Fatigue Intensity Score	Baseline (pre) and 8 weeks (post)	Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.; A score of 0 indicates no fatigue and a score of 10 indicates extremely severe fatigue.
Daily Average Fatigue Interference Score	Baseline (pre) and 8 weeks (post)	Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.' A score of 0 indicates no interference while a score of 10 indicates complete interference (i.e., worse).

Trial Locations

Locations (1)

Wayne State University; 🇺🇸 Detroit, Michigan, United States