Multiple Sclerosis Clinical Trial

Examining the Effects of a Telehealth Self-management Intervention in Multiple Sclerosis

Summary

The objective of this study is to conduct a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals in managing fatigue and increasing physical activity (PA) behavior in individuals with multiple sclerosis (MS). The hypothesis is that a fatigue management plus physical activity intervention will significantly improve fatigue, quality of life, physical function, and community integration.

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Full Description

The long-term objective of this study is to use a telehealth intervention approach to reduce the devastating effects of the reciprocal relationship between fatigue and inactivity on quality of life and participation in life roles in people with multiple sclerosis (MS). Chronic fatigue and inactivity are common problems in persons with MS, and the reciprocal relationship between fatigue and inactivity may have negative synergistic effects on quality of life and participation in life roles. The proposed study is novel in that it represents a multi-disciplinary effort to merge two promising lines of MS research: fatigue management and PA promotion. The proposed fatigue management plus PA intervention (FM+) will consist of incorporating a modified teleconference version of Packer et al.'s empirically-tested Fatigue Management program with innovative, yet simple approaches to promote lifestyle PA by encouraging goal-setting and self-monitoring with a pedometer. Ambulatory individuals with MS will be recruited and randomized into one of three telehealth interventions: social support intervention, PA-only intervention, and FM+.

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Eligibility Criteria

Inclusion Criteria:

A physician-confirmed diagnosis of MS

Exclusion Criteria:

Exercise more than 90 minutes per week
Pregnant
Metabolic or cardiopulmonary disease that puts patient at high risk for engaging in a home exercise program (patients with controlled diabetes and high blood pressure will still be considered eligible)
Four or more falls in the past 6 months
Be able to walk 25 feet with or without a cane or walker
Severe cognitive deficits
A condition besides MS that had lead to hospitalization in the past year

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

208

Study ID:

NCT01572714

Recruitment Status:

Completed

Sponsor:

Case Western Reserve University

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There is 1 Location for this study

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Case Western Reserve University
Cleveland Ohio, 44106, United States

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

208

Study ID:

NCT01572714

Recruitment Status:

Completed

Sponsor:


Case Western Reserve University

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