Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Department of Veterans Affairs Identifier:
First received: September 8, 2010
Last updated: November 3, 2014
Last verified: November 2014

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:

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
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01198977

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

No publications provided

Responsible Party: Department of Veterans Affairs Identifier: NCT01198977     History of Changes
Other Study ID Numbers: B4972-W
Study First Received: September 8, 2010
Last Updated: November 3, 2014
Health Authority: United States: Federal Government processed this record on March 03, 2015