Rheumatoid ArthritisNCT00327275
The Effects of a 16-Week Individualized, Intensive Strength Training Program in Patients With Rheumatoid Arthritis
A study testing strength training in people with Rheumatoid Arthritis, run by University of Arizona at 1 site in United States.
Trial summary
To assess the effects of a 16-week individualized, intensive strength training program in patients with rheumatoid arthritis. Primary and secondary outcomes include: strength and body composition, function, disease activity, pain, quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- strength training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jan 2005
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females with RA
- Over 18 years of age
- ACR Functional Class I and II
- Taking Remicade >4 months
Who cannot join
- Presence of comorbid conditions contraindicated to exercise, including, but not limited to:
- heart disease
- severe osteoporosis: (if >50 years): T score < -3.0 for hip or spine excluded; T score <-2.5 for hip or spine w/o current treatment)
- (all potential subjects) previous non-traumatic fractures
- uncontrolled BP
- BMI >40
Show all 13Show fewer
- Regular use of assistive walking device which would interfere with ability to lift weights
- Currently or within the last 3 months participating in aerobic exercise > 150 minutes a week
- Currently or within the last 3 months participating in any regular strength training activities
- Presence of neurological impairment that directly limits ability to perform exercise
- Participation in concurrent exercise study
- Any reason for which the investigator deems it would not be in the patient's best interest to continue in the study
- Plans to move away from site within next 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Strength Training and Remicade Study
To assess the effects of a 16-week individualized, intensive strength training program in patients with rheumatoid arthritis. Primary and secondary outcomes include: strength and body composition, function, disease activity, pain, quality of life.
We hypothesized that improvements would be seen in all of the above outcomes.
- Conditions
- Rheumatoid Arthritis
- Being tested
- strength training
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strength trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Body Composition
Function
Pain
Secondary outcomes (3)
Quality of Life
Disease Activity
Fatigue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startMar 2004
- Study completionJan 2005
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 ArizonaThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Investigators
- Hilary G Flint-Wagner, PhD, MPH, Principal investigator, Idaho State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327275
- Sponsor's protocol ID
- 080192
- Status last verified
- May 2006
- First submitted
- 16 May 2006
- Last updated
- 18 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Strength Training and Remicade Study
- ClinicalTrials.gov ID
- NCT00327275
- Acronym / sponsor ID
- 080192
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- Mar 2004
- Study completion
- Jan 2005
- First posted
- 18 May 2006 (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.
To assess the effects of a 16-week individualized, intensive strength training program in patients with rheumatoid arthritis. Primary and secondary outcomes include: strength and body composition, function, disease activity, pain, quality of life.
We hypothesized that improvements would be seen in all of the above outcomes.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females with RA
- Over 18 years of age
- ACR Functional Class I and II
- Taking Remicade >4 months
Key exclusion criteria (13 listed)
- Presence of comorbid conditions contraindicated to exercise, including, but not limited to:
- BMI >40
- Regular use of assistive walking device which would interfere with ability to lift weights
- Currently or within the last 3 months participating in aerobic exercise > 150 minutes a week
- Currently or within the last 3 months participating in any regular strength training activities
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 |
|---|---|---|
| strength training | Behavioural | – |
Primary outcome
Strength
Body Composition
Function
Pain
3 secondary outcomes
Quality of Life
Disease Activity
Fatigue
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 18 May 2006.
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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.
Hilary G Flint-Wagner, PhD, MPH principal investigator
Idaho State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strength training in people with Rheumatoid Arthritis, run by University of Arizona 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 4 inclusion and 13 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 18 May 2006. 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?
Strength. The study lists 4 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 18 May 2006.