N/A
N=20
Telephone-Delivered Exercise for Multiple Sclerosis Fatigue
Multiple Sclerosis · Fatigue · Physical Activity
Bottom Line
View on ClinicalTrials.gov: NCT03256851 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Daily Average Fatigue Intensity Score — 3.9; 4.4; 3.2; 2.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telephone-Delivered Exercise Therapy (Behavioral); In-Person Delivered Exercise Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wayne State University
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Average Fatigue Intensity Score |
3.9; 4.4; 3.2; 2.3 | — |
| PRIMARY Daily Average Fatigue Interference Score |
3.1; 3.0; 2.7; 1.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03256851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.