Trial of a Physical Activity Intervention for RA Fatigue

NCT ID: NCT01874977

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-03-31

Brief 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 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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pedometer only

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.)

Group Type: EXPERIMENTAL

Pedometer

Intervention Type: BEHAVIORAL

Will receive the educational booklet and discussion, plus a pedometer and a diary to record their daily step counts from the pedometer.

Educational materials

Intervention Type: 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.

Pedometer + step count goals

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.

Group Type: EXPERIMENTAL

Pedometer

Intervention Type: BEHAVIORAL

Will receive the educational booklet and discussion, plus a pedometer and a diary to record their daily step counts from the pedometer.

Educational materials

Intervention Type: 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

Intervention Type: BEHAVIORAL

Will receive the educational booklet and discussion, and the pedometer and step diary, plus will be given individualized daily step targets.

Education materials

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.

Group Type: OTHER

Educational materials

Intervention Type: 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.

Interventions

Pedometer

Will receive the educational booklet and discussion, plus a pedometer and a diary to record their daily step counts from the pedometer.

Intervention Type: BEHAVIORAL

Educational materials

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.

Intervention Type: BEHAVIORAL

Step count goals

Will receive the educational booklet and discussion, and the pedometer and step diary, plus will be given individualized daily step targets.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Physicians' diagnosis of RA
• English verbal fluency
• Residence in the greater San Francisco Bay Area
• Score ≥20 on 10-item PROMIS fatigue scale, or at least one item rated "often"
• BMI ≥ 20 kg/m2

Exclusion Criteria

• Currently engaging in regular exercise
• Non-ambulatory or presence of a condition or comorbid disease that would limit the ability to engage in walking (e.g., foot deformities, lower extremity joint surgery upcoming or in past 6 months, myocardial infarction in past 6 months, stroke, congestive heart failure, severe chronic obstructive pulmonary disease).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Patti Katz

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia Katz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28378441 (View on PubMed)

Other Identifiers

CA-0047102

Identifier Type: -

Identifier Source: org_study_id