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Clinical Trials/NCT03256851
NCT03256851CompletedNot Applicable

Telephone-Delivered Interventions to Target Multiple Sclerosis Fatigue

Wayne State University2 sites in 1 country20 target enrollmentStarted: June 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
Daily Average Fatigue Intensity Score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Daily Average Fatigue Intensity Score

Time Frame: 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

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nora Fritz

Assistant Professor

Wayne State University

Study Sites (2)

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