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Completed

NCT Number: NCT01874977

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 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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

pedometer

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

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.

Primary outcomes

  1. PROMIS Fatigue scale

    Time frame: change from baseline fatigue score at 20 weeks

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: change from baseline PHQ-9 score at 20 weeks

    depressive symptoms

  2. Pittsburg Sleep Quality Index (PSQI)

    Time frame: Change from baseline PSQI score at 20 weeks

    self-reported sleep quality

  3. Change in weight

    Time frame: Change from baseline weight at 20 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Randomized Controlled Trial of a Physical Activity Intervention for RA Fatigue

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 11, 2013
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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