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Telehealth-Based Exercise Program to Treat Fatigue in MS (MS-FIT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01198977
First received: September 8, 2010
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Multiple Sclerosis
 Behavioral: Brief telephone-based counseling
Other: Informational video

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telehealth-Based Exercise Program to Treat Fatigue in MS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Fatigue [ Time Frame: Past 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Telephone based counseling and instructional video
 Behavioral: Brief telephone-based counseling
Motivational interviewing and exercise goal setting and problem solving
Active Comparator: Arm 2
Exercise information and instructional video
 Other: Informational video
Mailed video of exercise programs

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multiple Sclerosis
  • Veteran receiving services in VA VISN 20
  • Fatigue
  • Ability to ambulate
  • Household phone line

Exclusion Criteria:

  • Current alcohol dependence or other substance dependence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198977

Locations
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Aaron P. Turner, PhD VA Puget Sound Health Care System, Seattle
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01198977     History of Changes
Other Study ID Numbers: B4972-W
Study First Received: September 8, 2010
Last Updated: January 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013