Arthritis, RheumatoidPhase 2NCT00855322
Study Examining the Effect of Exercise in People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
A Phase 2 study testing Gym exercise group intervention and Hydrotherapy group exercise intervention in people with Arthritis, Rheumatoid, run by University College Dublin at 1 site in Ireland.
Trial summary
The purpose of this study is to determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Gym exercise group intervention and Hydrotherapy group exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2008to Jul 2009
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with RA receiving anti-TNFalpha therapy medication for more than three months
- Consenting male and female patients aged 18 - 70 years
- Patients will have a documented diagnosis of RA as classified by the American College of Rheumatology (ACR) criteria
- ACR functional class I, II, III
Who cannot join
- Patients who have attended physiotherapy in the past three months
- Patients to whom exercise therapy or hydrotherapy are contraindicated
- Patients who have undergone joint surgery in the past six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
The purpose of this study is to determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication
Read the detailed description
Substantial progress has been made in the medical management of RA over the past decade but at present no drug therapy leads to long-term remission for all patients with RA. People may still continue to experience physical, psychological and functional consequences which could benefit from rehabilitation.little research exists on the effects of exercise for people with RA taking anti-TNFalpha therapy medication.
It is proposed to conduct a randomized controlled trial to examine the effects of group exercise therapy in a gym setting or in a hydrotherapy pool compared to a control group.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Gym exercise group intervention, Hydrotherapy group exercise intervention, Control group
- Keywords
- Arthritis, Rheumatoid, Exercise, Biological Therapy
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gym exercise group interventionOther
Also called Gym Group
Gym based circuit class
Hydrotherapy group exercise interventionOther
Also called Aquatic Physiotherapy
Hydrotherapy group exercise class
Control groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Gym group exercise intervention Receives: Other: Gym exercise group intervention |
| 2 | Experimental | Hydrotherapy group exercise intervention Receives: Other: Hydrotherapy group exercise intervention |
| 3 | No intervention | Control group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stanford Health Assessment Questionnaire
Measured: Baseline, 8 weeks and 24 weeks
Secondary outcomes (1)
50 foot Walk Test
Measured: Baseline, 8 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Investigators
- Oliver FitzGerald, MB, BcH, BAO, Principal investigator, University College DublinTara Cusack, PhD, MMedSc,, Study director, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855322
- Sponsor's protocol ID
- RAEx-0809
- Status last verified
- Feb 2009
- First submitted
- 2 Mar 2009
- Last updated
- 4 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Reid A, Brady A, Blake C, Mongey AB, Veale DJ, FitzGerald O, Cusack T. Randomised controlled trial examining the effect of exercise in people with rheumatoid arthritis taking anti-TNFalpha therapy medication. BMC Musculoskelet Disord. 2011 Jan 13;12:11. doi: 10.1186/1471-2474-12-11.
PubMed 21232112
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Examining The Effect Of Exercise In People With Rheumatoid Arthritis Taking Anti-TNFalpha Medication
- ClinicalTrials.gov ID
- NCT00855322
- Acronym / sponsor ID
- RAEx-0809
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Arthritis, Rheumatoid, Exercise, Biological Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 4 Mar 2009 (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.
The purpose of this study is to determine whether exercise is beneficial for people with rheumatoid arthritis(RA) taking antiTNFalpha medication
Detailed description
Substantial progress has been made in the medical management of RA over the past decade but at present no drug therapy leads to long-term remission for all patients with RA. People may still continue to experience physical, psychological and functional consequences which could benefit from rehabilitation.little research exists on the effects of exercise for people with RA taking anti-TNFalpha therapy medication.
It is proposed to conduct a randomized controlled trial to examine the effects of group exercise therapy in a gym setting or in a hydrotherapy pool compared to a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Gym exercise group interventionGym group exercise intervention |
| 2 | Experimental | Other: Hydrotherapy group exercise interventionHydrotherapy group exercise intervention |
| 3 | No intervention | Other: Control groupControl group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with RA receiving anti-TNFalpha therapy medication for more than three months
- Consenting male and female patients aged 18 - 70 years
- Patients will have a documented diagnosis of RA as classified by the American College of Rheumatology (ACR) criteria
- ACR functional class I, II, III
Key exclusion criteria (3 listed)
- Patients who have attended physiotherapy in the past three months
- Patients to whom exercise therapy or hydrotherapy are contraindicated
- Patients who have undergone joint surgery in the past six months
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 |
|---|---|---|
| Gym exercise group interventionAlso: Gym GroupGym based circuit class | Other | 1 |
| Hydrotherapy group exercise interventionAlso: Aquatic PhysiotherapyHydrotherapy group exercise class | Other | 2 |
| Control groupNo intervention | Other | 3 |
Primary outcome
Stanford Health Assessment Questionnaire
Time frame: Baseline, 8 weeks and 24 weeks
1 secondary outcome
50 foot Walk Test
Time frame: Baseline, 8 weeks and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2009.
- Derived from this study: PubMed 21232112Reid A, Brady A, Blake C, Mongey AB, Veale DJ, FitzGerald O, Cusack T. Randomised controlled trial examining the effect of exercise in people with rheumatoid arthritis taking anti-TNFalpha therapy medication. BMC Musculoskelet Disord. 2011 Jan 13;12:11. doi: 10.1186/1471-2474-12-11.
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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.
Oliver FitzGerald, MB, BcH, BAO principal investigator
University College Dublin
Tara Cusack, PhD, MMedSc, study director
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gym exercise group intervention and Hydrotherapy group exercise intervention in people with Arthritis, Rheumatoid, run by University College Dublin at 1 site in Ireland.
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 3 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: status not confirmed, as of the sponsor's last update on 4 Mar 2009. 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 Ireland. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Stanford Health Assessment Questionnaire (time frame: Baseline, 8 weeks and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855322, which also lists 1 linked publication.
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 4 Mar 2009.