Rheumatoid ArthritisRA&ExNCT00792675
Effect of Exercise on the Disease Activity of Rheumatoid Arthritis
A study testing Aerobic and resistance exercise training in people with Rheumatoid Arthritis, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Aerobic and resistance exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2003to 1 Nov 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Activity Lab, University of Nebraska Omaha
Omaha, Nebraska, 69189-4420
About this study
Official title: Evaluation of the Effect of Exercise on Disease Activity and Immune Parameters in Persons With Rheumatoid Arthritis
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Aerobic and resistance exercise training
- Keywords
- exercise, disease activity, inflammation, resistance training, rehabilitation
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and resistance exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Aerobic and resistance exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swollen Joint Count
Measured: 12 Weeks
Tender Joint Count
Measured: 12 Weeks
Secondary outcomes (8)
Pain (visual Analog Scale)
Measured: 12 Weeks
Modified-Health Assessment Questionnaire
Measured: 12 Weeks
Estimated Aerobic Capacity (VO2max)
Measured: 12 weeks
SF-36
Measured: 12 Weeks
Patient Global Assessment
Measured: 12 Weeks
Practitioner Global Assessment
Measured: 12 Weeks
Timed-Stands Test
Measured: 12 Weeks
50 Foot Walk Test
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study start1 Jan 2003
- Primary completion1 Apr 2006
- Study completion1 Nov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation, Nebraska Chapter Arthritis Foundation
- Responsible party
- Sponsor
- Investigators
- Laura D Bilek, PhD, PT, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792675
- Sponsor's protocol ID
- 0267-02-FB
- Acronym
- RA&Ex
- Status last verified
- Aug 2023
- First submitted
- 17 Nov 2008
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Exercise on Disease Activity and Immune Parameters in Persons With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00792675
- Acronym / sponsor ID
- RA&Ex / 0267-02-FB
- Conditions
- Rheumatoid Arthritis
- Keywords
- exercise, disease activity, inflammation, resistance training, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Arthritis Foundation, Nebraska Chapter Arthritis Foundation
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 1 Apr 2006 (actual)
- Study completion
- 1 Nov 2006 (actual)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Aerobic and resistance exercise trainingExercise 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic and resistance exercise trainingExercise 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. | Other | Exercise |
Primary outcome
Swollen Joint Count
Time frame: 12 Weeks
Tender Joint Count
Time frame: 12 Weeks
8 secondary outcomes
Pain (visual Analog Scale)
Time frame: 12 Weeks
Modified-Health Assessment Questionnaire
Time frame: 12 Weeks
Estimated Aerobic Capacity (VO2max)
Time frame: 12 weeks
SF-36
Time frame: 12 Weeks
Patient Global Assessment
Time frame: 12 Weeks
Practitioner Global Assessment
Time frame: 12 Weeks
Timed-Stands Test
Time frame: 12 Weeks
50 Foot Walk Test
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura D Bilek, PhD, PT principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and resistance exercise training in people with Rheumatoid Arthritis, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swollen Joint Count (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.