Examining the Effects of Physical Activity Promotion, Fatigue Management Education, and Social Support Using a Telehealth Intervention Approach Among Adults With Multiple Sclerosis
| City: |
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Cleveland |
| State: |
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Ohio |
| Zip Code: |
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44195 |
| Conditions: |
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Multiple Sclerosis |
| Purpose: |
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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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| Study Summary: |
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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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| Criteria: |
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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
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| NCT ID: |
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NCT01572714 |
| Primary Contact: |
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Principal Investigator
Matthew A Plow, PhD
The Cleveland Clinic
Corey McDaniel, BA
Phone: (216) 445-9674
Email: mcdanic3@ccf.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cleveland, Ohio 44195
United States
Corey McDaniel, BA
Phone: 216-445-9674
Email: mcdanic3@ccf.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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