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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01447264
Date of registration: 03/10/2011
Prospective Registration: No
Primary sponsor: Federal University of São Paulo
Public title: Effectiveness of Water Exercises on Isokinetic Muscle Strength
Scientific 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
Date of first enrolment: February 2009
Target sample size: 100
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01447264
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Brazil
Contacts
Name:     Marcelo M Pinheiro, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Federal University of Sao Paulo
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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;

Exclusion Criteria:

- 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;

- 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.



Age minimum: 40 Years
Age maximum: 65 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Procedure: Land exercises
Procedure: Water exercises
Primary Outcome(s)
Muscle strength [Time Frame: 16 weeks]
Secondary Outcome(s)
Body composition measurements [Time Frame: 16 weeks]
Health Assessment Questionnaire (HAQ) [Time Frame: 16 weeks]
Disease Activity Score (DAS28) [Time Frame: 16 weeks]
Secondary ID(s)
FUSaoPaulo-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Department of Medicine
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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