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Effect of Exercise on the Disease Activity of Rheumatoid Arthritis (RA&Ex)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic and resistance exercise training
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring exercise, disease activity, inflammation, resistance training, rehabilitation

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • a diagnosis of RA according to the ACR 1989 Criteria at least 6 months prior to enrollment in the study, but not longer than 12 years
  • age 19 to 65 years old
  • stable regimen of medication for 2 months with less than 10 mg/day of oral corticosteroids
  • currently exercise < 2x/week for less than 30 minutes at less than 60% of his/her age predicted maximum heart rate
  • Subjects must pass the Physical Activity Readiness Scale Questionnaire (PAR-Q)

Exclusion Criteria:

  • other serious health problems
  • intra-articular injection within 6 weeks
  • total joint replacement of the large joints
  • use of beta-blockers
  • inability to complete the submaximal exercise test

Sites / Locations

  • Physical Activity Lab, University of Nebraska Omaha

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

Exercise consists of 30 minutes of treadmill exercise at approximately 85% of heart rate max and 2 sets of 6 resistance weight lifting exercises resulting in volitional fatigue at 12 to 15 repetitions.

Outcomes

Primary Outcome Measures

Swollen Joint Count
Tender Joint Count

Secondary Outcome Measures

Pain (visual Analog Scale)
Modified-Health Assessment Questionnaire
Estimated Aerobic Capacity (VO2max)
SF-36
Patient Global Assessment
Practitioner Global Assessment
Timed-Stands Test
50 Foot Walk Test

Full Information

First Posted
November 17, 2008
Last Updated
August 28, 2023
Sponsor
University of Nebraska
Collaborators
Arthritis Foundation, Nebraska Chapter Arthritis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00792675
Brief Title
Effect of Exercise on the Disease Activity of Rheumatoid Arthritis
Acronym
RA&Ex
Official Title
Evaluation of the Effect of Exercise on Disease Activity and Immune Parameters in Persons With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2003 (Actual)
Primary Completion Date
April 1, 2006 (Actual)
Study Completion Date
November 1, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Arthritis Foundation, Nebraska Chapter Arthritis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effect of exercise on the number of swollen and tender joints associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking and weightlifting.
Detailed Description
The goal of this study was to evaluate the effect of exercise on the number of swollen and tender joints associated with rheumatoid arthritis. It was hypothesized that persons would have less inflammation associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking and weighlifting. Immune parameters were measured to determine potential mechanisms responsible for changes in inflammation with exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
exercise, disease activity, inflammation, resistance training, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise consists of 30 minutes of treadmill exercise at approximately 85% of heart rate max and 2 sets of 6 resistance weight lifting exercises resulting in volitional fatigue at 12 to 15 repetitions.
Intervention Type
Other
Intervention Name(s)
Aerobic and resistance exercise training
Intervention Description
Exercise was performed 3 times per week. It consisted of 30 minutes of treadmill exercise at approximately 85% of heartrate max and 2 sets of 6 resistance weight lifting exercises resulting in volitional fatigue at 12 to 15 repetitions.
Primary Outcome Measure Information:
Title
Swollen Joint Count
Time Frame
12 Weeks
Title
Tender Joint Count
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Pain (visual Analog Scale)
Time Frame
12 Weeks
Title
Modified-Health Assessment Questionnaire
Time Frame
12 Weeks
Title
Estimated Aerobic Capacity (VO2max)
Time Frame
12 weeks
Title
SF-36
Time Frame
12 Weeks
Title
Patient Global Assessment
Time Frame
12 Weeks
Title
Practitioner Global Assessment
Time Frame
12 Weeks
Title
Timed-Stands Test
Time Frame
12 Weeks
Title
50 Foot Walk Test
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: a diagnosis of RA according to the ACR 1989 Criteria at least 6 months prior to enrollment in the study, but not longer than 12 years age 19 to 65 years old stable regimen of medication for 2 months with less than 10 mg/day of oral corticosteroids currently exercise < 2x/week for less than 30 minutes at less than 60% of his/her age predicted maximum heart rate Subjects must pass the Physical Activity Readiness Scale Questionnaire (PAR-Q) Exclusion Criteria: other serious health problems intra-articular injection within 6 weeks total joint replacement of the large joints use of beta-blockers inability to complete the submaximal exercise test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura D Bilek, PhD, PT
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Activity Lab, University of Nebraska Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
69189-4420
Country
United States

12. IPD Sharing Statement

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Effect of Exercise on the Disease Activity of Rheumatoid Arthritis

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