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

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ClinicalTrials.gov Identifier: NCT01198977
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : August 12, 2016
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.

Condition or disease Intervention/treatment
Multiple Sclerosis Behavioral: Brief telephone-based counseling Other: Education counseling

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  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telehealth-Based Exercise Program to Treat Fatigue in MS
Study Start Date : October 2009
Primary Completion Date : September 2015
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Brief telephone-based counseling
Telephone based counseling and instructional video
Behavioral: Brief telephone-based counseling
Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving
Placebo Comparator: Education Counseling
Mailed Physical Activity information and instructional video only
Other: Education counseling
Mailed informational video of exercise programs

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Depression [ Time Frame: baseline, 3 months, 6 months ]

    Depression Module of the Patient Health Questionnaire (PHQ-9). 9-item self-report instrument designed to identify depressive symptoms consistent with criteria for major depressive episode in the Diagnostic and Statistical Manual for Mental Disorders, 4th Edition. Each item is rated over the last 2 weeks: 0 (not at all), 1 (several days), 2 (more than half the days), or 3 (nearly every day).

    Total Score for 9 items = 27.

Other Outcome Measures:
  1. Physical Activity (Behavioral Target) [ Time Frame: baseline, 3 months, 6 months ]
    First item of the Godin Leisure-Time Exercise Questionnaire (GLTEQ). GLTEQ asks participants to indicated the number of days per week they engaged in strenuous (e.g., running), moderate (e.g., easy bicycling), and mild (e.g., easy walking) exercise activities for periods of 15 min or more. Total weekly frequency is then calculated using an algorithm that multiplies the frequency of activities by 9 (strenuous), 5 (moderate), or 3 (mild) metabolic equivalents and sums each to produce a total level of physical activity in MET/min per week.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Multiple Sclerosis
  • Veteran receiving services in VA VISN 20
  • Fatigue
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198977

United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Aaron P Turner, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
More Information

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01198977     History of Changes
Other Study ID Numbers: B4972-W
First Posted: September 10, 2010    Key Record Dates
Results First Posted: August 12, 2016
Last Update Posted: February 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
multiple sclerosis
motivational interviewing
physical activity

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