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Clinical Trials/NCT01198977
NCT01198977CompletedNot Applicable

Telehealth-Based Exercise Program to Treat Fatigue in MS

VA Office of Research and Development1 site in 1 country64 target enrollmentStarted: October 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
1
Primary Endpoint
Fatigue

Study Overview

Brief Summary

This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.

Detailed Description

This is a 2-arm single blind parallel group RCT comparing a brief telephone based motivational intervention to an informational control to improve adherence to exercise among individuals with MS. The primary outcome is improvement in fatigue.

Study Design

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

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Multiple Sclerosis
  • •Veteran receiving services in VA VISN 20
  • •Ability to ambulate
  • •cell phone or Household phone line
  • •Individual with multiple sclerosis verified by MS provider
  • •ambulatory

Exclusion Criteria

  • •Current alcohol dependence or other substance dependence
  • •No working phone

Arms & Interventions

Brief telephone-based counseling

Active Comparator

Telephone based counseling and instructional video

Intervention: Brief telephone-based counseling (Behavioral)

Education Counseling

Placebo Comparator

Mailed Physical Activity information and instructional video only

Intervention: Education counseling (Other)

Outcomes

Primary Outcomes

Fatigue

Time Frame: baseline, 3 months, 6 months

Modified Fatigue Inventory Scale (MFIS) at baseline, 3-month, 6-month MFIS consisted of 21 items, ranging from 0 (never) to 4 (almost always). The total score was 0 to 84.

Secondary Outcomes

  • Depression(baseline, 3 months, 6 months)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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