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Telephone-Delivered Exercise for Multiple Sclerosis Fatigue

Not Applicable
Completed
Conditions
Physical Activity
Multiple Sclerosis
Fatigue
Interventions
Behavioral: Telephone-Delivered Exercise Therapy
Behavioral: In-Person Delivered Exercise Therapy
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

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
Arm && Interventions
GroupInterventionDescription
Telephone-Delivered ExerciseTelephone-Delivered Exercise TherapyParticipants in the telephone-delivered training group will: 1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week. 2. receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report their progress from the prior week, discuss/troubleshoot any issues or problems, and receive progressions of both aerobic and strength training exercises for the upcoming week.
In-Person Delivered ExerciseIn-Person Delivered Exercise TherapyParticipants in the in-person training group will: 1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week. 2. complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.
Primary Outcome Measures
NameTimeMethod
Daily Average Fatigue Intensity ScoreBaseline (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 ScoreBaseline (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 Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Wayne State University

🇺🇸

Detroit, Michigan, United States

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