An interventional study of Pedometer and Educational materials in Rheumatoid Arthritis, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 96 is close to the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
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.)
Behavioral: Pedometer · Behavioral: Educational materials
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.
Behavioral: Pedometer · Behavioral: Educational materials · Behavioral: Step count goals
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.
Behavioral: Educational materials
Will receive the educational booklet and discussion, plus a pedometer and a diary to record their daily step counts from the pedometer.
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.
Will receive the educational booklet and discussion, and the pedometer and step diary, plus will be given individualized daily step targets.
PROMIS Fatigue scale
Time frame: change from baseline fatigue score at 20 weeks
Patient Health Questionnaire-9 (PHQ-9)
depressive symptoms
Time frame: change from baseline PHQ-9 score at 20 weeks
Pittsburg Sleep Quality Index (PSQI)
self-reported sleep quality
Time frame: Change from baseline PSQI score at 20 weeks
Change in weight
Time frame: Change from baseline weight at 20 weeks
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco