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

• ClinicalTrials.gov Identifier: NCT01198977
• Recruitment Status: Completed
• First Posted: September 10, 2010
• Results First Posted: August 12, 2016
• Last Update Posted: October 9, 2019
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

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	Phase
Multiple Sclerosis	Behavioral: Brief telephone-based counseling; Other: Education counseling	Not Applicable

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
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: December 2016

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

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Informed Consent Form  [PDF] June 22, 2009

More Information

Additional Information:

VA Multiple Sclerosis Centers of Excellence web page 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Turner AP, Hartoonian N, Hughes AJ, Arewasikporn A, Alschuler KN, Sloan AP, Ehde DM, Haselkorn JK. Physical activity and depression in MS: The mediating role of behavioral activation. Disabil Health J. 2019 Oct;12(4):635-640. doi: 10.1016/j.dhjo.2019.04.004. Epub 2019 Apr 30.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01198977
• Other Study ID Numbers: B4972-W
• First Posted: September 10, 2010
• Results First Posted: August 12, 2016
• Last Update Posted: October 9, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• 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:

Multiple Sclerosis; Sclerosis; Fatigue; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases