Trial of a Physical Activity Intervention for RA Fatigue

Rheumatoid Arthritis Clinical Trial

Official title:

Randomized Controlled Trial of a Physical Activity Intervention for RA Fatigue

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01874977
• Other study ID #: CA-0047102
• Status: Active, not recruiting
• Phase: N/A
• First received: June 5, 2013
• Last updated: December 14, 2015
• Start date: November 2013
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Pedometer
Will receive the educational booklet and discussion, plus a pedometer and a diary to record their daily step counts from the pedometer.
• 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.
• Step count goals
Will receive the educational booklet and discussion, and the pedometer and step diary, plus will be given individualized daily step targets.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS Fatigue scale		change from baseline fatigue score at 20 weeks	No
Secondary	Patient Health Questionnaire-9 (PHQ-9)	depressive symptoms	change from baseline PHQ-9 score at 20 weeks	No
Secondary	Pittsburg Sleep Quality Index (PSQI)	self-reported sleep quality	Change from baseline PSQI score at 20 weeks	No
Secondary	Change in weight		Change from baseline weight at 20 weeks	No