Effectiveness of Water Exercises on Isokinetic Muscle Strength

• 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
• 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: Water exercises

Procedure: Land exercises

Primary Outcome(s)

Muscle strength [Time Frame: 16 weeks]

Secondary Outcome(s)

Disease Activity Score (DAS28) [Time Frame: 16 weeks]

Body composition measurements [Time Frame: 16 weeks]

Health Assessment Questionnaire (HAQ) [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