Rheumatoid ArthritisPhase 3NCT01447264
Effectiveness of Water Exercises on Isokinetic Muscle Strength
A Phase 3 study testing Land exercises and Water exercises in people with Rheumatoid Arthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The interest in studying the impact of aquatic exercise on muscle strength of patients with rheumatoid arthritis came after publication of several studies that pointed to the potential benefit of exercise on the natural history of the disease, including reduction of pain, better immune response as well as aerobic… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Land exercises and Water exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Apr 2011
- Phase
- Phase 3
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females;
- Pre- or postmenopausal;
- Disease Activity: from mild to moderate, according to the DAS28;
- Functional class I and II Steinbrocker;
- No rehabilitation program in the last three months;
- Stable medication in the three months before randomization;
- Cardiorespiratory fitness after exercise testing and cardiologic exam;
- Agree and sign the Instrument of Consent;
Who cannot join
- Circulatory problems, ulcers in the legs, or other untreated skin lesions that would preclude the exercise in the pool;
- Physical activity regularly in the three months prior to intervention;
- Use of orthoses or any other devices;
- Hip or knee prosthesis;
- Regular use of proteic supplements or anabolic drugs;
- Orthopedic surgery scheduled for the next six months;
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- Intra-articular infiltration in the three months prior to randomization or scheduled for the next six months;
- Illiteracy and cognitive impairment;
- Hearing loss and visual;
- Phobia of water;
- Hypersensitivity to the chlorine;
- Epilepsy and urinary or fecal incontinence;
- Any uncontrolled chronic illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness Between Land and Water Exercises on Isokinetic Muscle Strength of Lower Limbs in Women With Rheumatoid Arthritis: a Randomized Controlled Trial
The interest in studying the impact of aquatic exercise on muscle strength of patients with rheumatoid arthritis came after publication of several studies that pointed to the potential benefit of exercise on the natural history of the disease, including reduction of pain, better immune response as well as aerobic fitness and functional capacity and increase muscle strength, endurance and quality of life.
In general, the aquatic exercises are indicated for patients with chronic joint diseases, since the aquatic environment seems to be more secure for this population due to the reduction of joint loading, as well as gain range of motion.
Read more
However, there are some difficulties to show the real and consistent beneficial effect of physical activity in these patients, such as the small number of randomized controlled clinical trials, short intervention period (4-8 weeks), lack of details of the exercise protocols used, methodological problems (heterogeneous measures to evaluate the outcome, change of medication). Moreover, no study evaluated the disease activity, according to the tool most used clinically worldwide, the DAS28.
It is known that aquatic exercises without impact in healthy subjects are sufficient to gain muscle strength. Nonetheless, in people with joint limitation the benefits from these same exercises to gain muscle strength is not known.
To date, no studies addressing the effect of aquatic exercise on muscle strength and disease activity in patients with rheumatoid arthritis. In addition, there is the need to obtain a standardized protocol for prescribing of aquatic exercises. The choice of lower-limb strength was based on its relevance to the acceleration and deceleration during the march, as well as to perform activities of daily living, leisure and professional in these individuals.
Thus, this study aims at:
- Exercises performed in the aquatic environment and without the concomitant use of overhead equipment are sufficient to promote gain muscle strength in the lower limb?
- What is the isolated effect of water resistance on muscle strength? Could it work as an impact that is used in exercises done on the land?
Read the detailed description
The investigators objectives are:
- To compare the peak torque of flexor and extensor of the knee between land and water exercises in women with rheumatoid arthritis. This is a randomized controlled clinical trial with 16 weeks of length;
- To verify the changes of disease activity, functional capacity and body composition measurements before and after the intervention
- Conditions
- Rheumatoid Arthritis
- Being tested
- Land exercises, Water exercises
- Keywords
- Rheumatoid arthritis, Muscle strength, Body composition, Physical activity, Water exercises, Hydrotherapy, Randomized controlled clinical trial
- 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.
Land exercisesProcedure or surgery
3 times a week. 50 minutes in every session. Performed by educational professor
Water exercisesProcedure or surgery
3 times a week. 50 minutes in every session. Performed by educational professor
| Study group | Role | What they receive |
|---|---|---|
| Land exercises | Placebo comparator | The patients of this group will perform the same exercises from water exercises Receives: Procedure: Land exercises |
| Water exercises | Active comparator | The patients of this group will perform the same exercises from land exercises Receives: Procedure: Water exercises |
| Control group | No intervention | No intervention will be recommended |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Isokinetic muscle strength
Measured: 16 weeks
Secondary outcomes (3)
Disease Activity Score (DAS28)
To evaluate the disease activity in rheumatoid arthritis
Measured: 16 weeks
Health Assessment Questionnaire (HAQ)
To measure the impact of funcional capacity in patients with rheumatoid arthritis
Measured: 16 weeks
Body composition measurements
Measures of body composition (lean and fat mass), by Dual-X ray absorptiometry (DXA)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startFeb 2009
- Primary completionDec 2010
- Study completionApr 2011
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Medicine
- Responsible party
- Principal investigator, Marcelo M Pinheiro, Federal University of São Paulo
- Investigators
- Marcelo M Pinheiro, MD, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447264
- Sponsor's protocol ID
- FUSaoPaulo-01
- Status last verified
- Oct 2011
- First submitted
- 3 Oct 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness Between Land and Water Exercises on Isokinetic Muscle Strength of Lower Limbs in Women With Rheumatoid Arthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01447264
- Acronym / sponsor ID
- FUSaoPaulo-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Muscle strength, Body composition, Physical activity, Water exercises, Hydrotherapy, Randomized controlled clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Department of Medicine
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 6 Oct 2011 (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 interest in studying the impact of aquatic exercise on muscle strength of patients with rheumatoid arthritis came after publication of several studies that pointed to the potential benefit of exercise on the natural history of the disease, including reduction of pain, better immune response as well as aerobic fitness and functional capacity and increase muscle strength, endurance and quality of life.
In general, the aquatic exercises are indicated for patients with chronic joint diseases, since the aquatic environment seems to be more secure for this population due to the reduction of joint loading, as well as gain range of motion.
However, there are some difficulties to show the real and consistent beneficial effect of physical activity in these patients, such as the small number of randomized controlled clinical trials, short intervention period (4-8 weeks), lack of details of the exercise protocols used, methodological problems (heterogeneous measures to evaluate the outcome, change of medication). Moreover, no study evaluated the disease activity, according to the tool most used clinically worldwide, the DAS28.
It is known that aquatic exercises without impact in healthy subjects are sufficient to gain muscle strength. Nonetheless, in people with joint limitation the benefits from these same exercises to gain muscle strength is not known.
To date, no studies addressing the effect of aquatic exercise on muscle strength and disease activity in patients with rheumatoid arthritis. In addition, there is the need to obtain a standardized protocol for prescribing of aquatic exercises. The choice of lower-limb strength was based on its relevance to the acceleration and deceleration during the march, as well as to perform activities of daily living, leisure and professional in these individuals.
Thus, this study aims at:
- Exercises performed in the aquatic environment and without the concomitant use of overhead equipment are sufficient to promote gain muscle strength in the lower limb?
- What is the isolated effect of water resistance on muscle strength? Could it work as an impact that is used in exercises done on the land?
Detailed description
The investigators objectives are:
- To compare the peak torque of flexor and extensor of the knee between land and water exercises in women with rheumatoid arthritis. This is a randomized controlled clinical trial with 16 weeks of length;
- To verify the changes of disease activity, functional capacity and body composition measurements before and after the intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Land exercises | Placebo comparator | Procedure: Land exercisesThe patients of this group will perform the same exercises from water exercises |
| Water exercises | Active comparator | Procedure: Water exercisesThe patients of this group will perform the same exercises from land exercises |
| Control group | No intervention | –No intervention will be recommended |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Females;
- Pre- or postmenopausal;
- Disease Activity: from mild to moderate, according to the DAS28;
- Functional class I and II Steinbrocker;
- No rehabilitation program in the last three months;
Key exclusion criteria (13 listed)
- Circulatory problems, ulcers in the legs, or other untreated skin lesions that would preclude the exercise in the pool;
- Physical activity regularly in the three months prior to intervention;
- Use of orthoses or any other devices;
- Hip or knee prosthesis;
- Regular use of proteic supplements or anabolic drugs;
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 |
|---|---|---|
| Land exercises3 times a week. 50 minutes in every session. Performed by educational professor | Procedure or surgery | Land exercises |
| Water exercises3 times a week. 50 minutes in every session. Performed by educational professor | Procedure or surgery | Water exercises |
Primary outcome
Muscle strength
Time frame: 16 weeks
Isokinetic muscle strength
3 secondary outcomes
Disease Activity Score (DAS28)
Time frame: 16 weeks
Health Assessment Questionnaire (HAQ)
Time frame: 16 weeks
Body composition measurements
Time frame: 16 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 6 Oct 2011.
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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.
Marcelo M Pinheiro, MD, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Land exercises and Water exercises in people with Rheumatoid Arthritis, run by Federal University of São Paulo at 1 site in Brazil.
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 8 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 6 Oct 2011. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Muscle strength (time frame: 16 weeks). 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 6 Oct 2011.