Telehealth-Based Exercise Program to Treat Fatigue in MS

Multiple Sclerosis Clinical Trial

— MS-FIT  

Official title:

Telehealth-Based Exercise Program to Treat Fatigue in MS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198977
• Other study ID #: B4972-W
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: December 2016

Study information

• Verified date: September 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a clinical trial examining a brief motivational intervention to improve adherence to exercise among individuals with MS to improve fatigue.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Ap — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Activity (Behavioral Target)	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.	baseline, 3 months, 6 months
Primary	Fatigue	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.	baseline, 3 months, 6 months
Secondary	Depression	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.	baseline, 3 months, 6 months

External Links

•   VA Multiple Sclerosis Centers of Excellence web page