NCT00792675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

3.2 years

First QC Date

November 17, 2008

Last Update Submit

August 28, 2023

Conditions

Keywords

exercisedisease activityinflammationresistance trainingrehabilitation

Outcome Measures

Primary Outcomes (2)

  • Swollen Joint Count

    12 Weeks

  • Tender Joint Count

    12 Weeks

Secondary Outcomes (8)

  • Pain (visual Analog Scale)

    12 Weeks

  • Modified-Health Assessment Questionnaire

    12 Weeks

  • Estimated Aerobic Capacity (VO2max)

    12 weeks

  • SF-36

    12 Weeks

  • Patient Global Assessment

    12 Weeks

  • +3 more secondary outcomes

Study Arms (1)

Exercise

EXPERIMENTAL

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.

Other: Aerobic and resistance exercise training

Interventions

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.

Exercise

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Activity Lab, University of Nebraska Omaha

Omaha, Nebraska, 69189-4420, United States

Location

MeSH Terms

Conditions

Arthritis, RheumatoidMotor ActivityInflammation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laura D Bilek, PhD, PT

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 18, 2008

Study Start

January 1, 2003

Primary Completion

April 1, 2006

Study Completion

November 1, 2006

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations