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Trial of a Physical Activity Intervention for RA Fatigue

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pedometer
Educational materials
Step count goals
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, fatigue, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Pedometer only

Pedometer + step count goals

Education materials

Arm Description

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.)

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.

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.

Outcomes

Primary Outcome Measures

PROMIS Fatigue scale

Secondary Outcome Measures

Patient Health Questionnaire-9 (PHQ-9)
depressive symptoms
Pittsburg Sleep Quality Index (PSQI)
self-reported sleep quality
Change in weight

Full Information

First Posted
June 5, 2013
Last Updated
May 10, 2016
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01874977
Brief Title
Trial of a Physical Activity Intervention for RA Fatigue
Official Title
Randomized Controlled Trial of a Physical Activity Intervention for RA Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, fatigue, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pedometer only
Arm Type
Experimental
Arm Description
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.)
Arm Title
Pedometer + step count goals
Arm Type
Experimental
Arm Description
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.
Arm Title
Education materials
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pedometer
Intervention Description
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
Intervention Name(s)
Educational materials
Intervention Description
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
Intervention Name(s)
Step count goals
Intervention Description
Will receive the educational booklet and discussion, and the pedometer and step diary, plus will be given individualized daily step targets.
Primary Outcome Measure Information:
Title
PROMIS Fatigue scale
Time Frame
change from baseline fatigue score at 20 weeks
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
depressive symptoms
Time Frame
change from baseline PHQ-9 score at 20 weeks
Title
Pittsburg Sleep Quality Index (PSQI)
Description
self-reported sleep quality
Time Frame
Change from baseline PSQI score at 20 weeks
Title
Change in weight
Time Frame
Change from baseline weight at 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Katz, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28378441
Citation
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.
Results Reference
derived

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Trial of a Physical Activity Intervention for RA Fatigue

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