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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01198977
First received: September 8, 2010
Last updated: August 9, 2016
Last verified: August 2016
  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: Education counseling

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 VA Office of Research and Development:

Primary Outcome Measures:
  • Fatigue [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    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:
  • Depression [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

    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:
  • Physical Activity (Behavioral Target) [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 64
Study Start Date: October 2009
Estimated Study Completion Date: December 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult, Senior)
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
  • 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
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 ClinicalTrials.gov identifier: NCT01198977

Locations
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
Investigators
Principal Investigator: Aaron P Turner, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
  More Information

Additional Information:
Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01198977     History of Changes
Other Study ID Numbers: B4972-W 
Study First Received: September 8, 2010
Results First Received: August 9, 2016
Last Updated: August 9, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
multiple sclerosis
Fatigue
exercise
telemedicine
motivational interviewing
counseling
depression
physical activity

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Fatigue
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

ClinicalTrials.gov processed this record on September 27, 2016