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NCT01874977 · ClinicalTrials.gov registry record · NA
Trial of a Physical Activity Intervention for RA Fatigue
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 96
- Enrollment target
NCT01874977 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 96 participants.
The verdict
NCT01874977, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
Study Summary
The major goal of this project is to conduct a randomized, controlled trial of the impact of a practical, low cost physical activity intervention on fatigue among persons with rheumatoid arthritis (RA). Fatigue has been identified as a major concern for individuals with RA, and is considered a core outcome measure for RA. Our recent study of the sources of fatigue identified physical inactivity as a primary predictor of fatigue. Studies have examined the impact of exercise interventions on RA outcomes, but most of these interventions have focused on pain or function as outcomes. The few exercise studies examining fatigue suggest that increasing physical activity reduces fatigue, but the interventions have been resource-intensive, requiring specially trained personnel to administer them, highly structured activities, and/or attendance at classes or a specified facility. Each of these components increases the cost and barriers to implementation of an intervention. Pedometers have been shown to be an effective means of increasing physical activity, and could form the basis of a simple means to increase physical activity. This project will test the effect of a simple pedometer-based intervention, with two incremental degrees of guidance, on increasing physical activity and decreasing fatigue. Three groups (n=40 in each) will be studied: a control group with an educational pamphlet only, a pedometer-only intervention group, and a pedometer group with step targets. Both intervention groups will keep step-count diaries. Groups will be followed over 20 weeks. We expect that (1) the pedometer-only intervention group will increase activity more than the education group, and the group with step-count targets will demonstrate even greater increases in activity; and (2) greater increases in activity will be associated with greater decreases in fatigue. Secondary outcome measures will include depressive symptoms, self-reported sleep quality, and body composition. Our overall goa
Interventions
- BEHAVIORAL Pedometer
- BEHAVIORAL Educational materials
- BEHAVIORAL Step count goals
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01874977
The ClinicalTrials.gov registry entry for NCT01874977 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pedometer is the first listed.
NCT01874977 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01874977 about?
NCT01874977 is a clinical study titled "Trial of a Physical Activity Intervention for RA Fatigue". The major goal of this project is to conduct a randomized, controlled trial of the impact of a practical, low cost physical activity intervention on fatigue among persons with rheumatoid arthritis (RA). Fatigue has been identified as a major concern for individuals with RA, and is considered a core ...
What is the current status of trial NCT01874977?
This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2013-11. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01874977?
The interventions under investigation include: Pedometer (BEHAVIORAL), Educational materials (BEHAVIORAL), Step count goals (BEHAVIORAL).
Who is sponsoring clinical trial NCT01874977?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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