Telehealth-Based Exercise Program to Treat Fatigue in MS (MS-FIT)
|Multiple Sclerosis||Behavioral: Brief telephone-based counseling Other: Education counseling|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Telehealth-Based Exercise Program to Treat Fatigue in MS|
- 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.
- 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.
- 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.
|Study Start Date:||October 2009|
|Study Completion Date:||December 2016|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198977
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Aaron P Turner, PhD||VA Puget Sound Health Care System Seattle Division, Seattle, WA|