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Completed

NCT Number: NCT01198977

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Fatigue Immune System Diseases Motor Activity Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief telephone-based counseling

Behavioral

Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving

Education counseling

Other

Mailed informational video of exercise programs

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: MS-FIT

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Sep 10, 2010
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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