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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 goal is to demonstrate an effective, yet simple and low cost, physical activity intervention to decrease fatigue that could be broadly accessible and have the potential for wide implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pedometer only | Experimental | This group will receive the educational booklet and discussion, plus a pedometer and a diary to record their daily step counts from the pedometer. Participants will be shown how to wear the pedometer, and instructed to wear it from the time they get out of bed in the morning until they go to bed at night, except while showering or bathing. (If any subjects begin a swimming- or cycling-based activity program, we will ask them to remove the pedometer at that time but track the time they are in the water. Step counts will be adjusted to account for this time by adding 150 steps for every minute engaged in swimming and/or cycling.) |
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| Pedometer + step count goals | Experimental | Pedometer + step goals. This group will receive the educational booklet and discussion, and the pedometer and step diary, plus will be given individualized daily step targets. |
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| Education materials | Other | Educational materials. This group will receive the educational booklet ("Be Active Your Way: A guide for Adults"; http://www.health.gov/paguidelines/adultguide/default.aspx).and a discussion of simple ways to increase physical activity in daily life based on the booklet, following the baseline assessment. They will receive follow-up contact at the same time points as the intervention groups, although the Week 0 and Week 1 contacts will be by phone instead of in-person and the content of contacts will be different. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedometer | Behavioral | Will receive the educational booklet and discussion, plus a pedometer and a diary to record their daily step counts from the pedometer. |
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| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Fatigue scale | change from baseline fatigue score at 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | depressive symptoms | change from baseline PHQ-9 score at 20 weeks |
| Pittsburg Sleep Quality Index (PSQI) | self-reported sleep quality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Katz, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28378441 | Derived | Katz P, Margaretten M, Gregorich S, Trupin L. Physical Activity to Reduce Fatigue in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Jan;70(1):1-10. doi: 10.1002/acr.23230. Epub 2017 Dec 6. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Educational materials | Behavioral | Will receive the educational booklet ("Be Active Your Way: A guide for Adults"; http://www.health.gov/paguidelines/adultguide/default.aspx).and a discussion of simple ways to increase physical activity in daily life based on the booklet, following the baseline assessment. |
|
| Step count goals | Behavioral | Will receive the educational booklet and discussion, and the pedometer and step diary, plus will be given individualized daily step targets. |
|
| Change from baseline PSQI score at 20 weeks |
| Change in weight | Change from baseline weight at 20 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |