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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):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01198977
First received: September 8, 2010
Last updated: January 10, 2017
Last verified: January 2017
September 8, 2010
January 10, 2017
October 2009
September 2015   (Final data collection date for primary outcome measure)
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.
Fatigue [ Time Frame: Past 4 weeks ]
Complete list of historical versions of study NCT01198977 on ClinicalTrials.gov Archive Site
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.

Not Provided
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.
Not Provided
 
Telehealth-Based Exercise Program to Treat Fatigue in MS
Telehealth-Based Exercise Program to Treat Fatigue in MS
This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • Behavioral: Brief telephone-based counseling
    Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving
  • Other: Education counseling
    Mailed informational video of exercise programs
  • Active Comparator: Brief telephone-based counseling
    Telephone based counseling and instructional video
    Intervention: Behavioral: Brief telephone-based counseling
  • Placebo Comparator: Education Counseling
    Mailed Physical Activity information and instructional video only
    Intervention: Other: Education counseling
Turner AP, Hartoonian N, Sloan AP, Benich M, Kivlahan DR, Hughes C, Hughes AJ, Haselkorn JK. Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling. J Consult Clin Psychol. 2016 Apr;84(4):297-309. doi: 10.1037/ccp0000086. Epub 2016 Feb 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
December 2016
September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01198977
B4972-W
No
Not Provided
No
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Aaron P Turner, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
VA Office of Research and Development
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP