Effectiveness of Water Exercises on Isokinetic Muscle Strength

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447264
• Other study ID #: FUSaoPaulo-01
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2011
• Last updated: October 5, 2011
• Start date: February 2009
• Est. completion date: April 2011

Study information

• Verified date: October 2011
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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 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:

1. 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?

2. 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?

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Procedure:
• Land exercises
3 times a week. 50 minutes in every session. Performed by educational professor
• Water exercises
3 times a week. 50 minutes in every session. Performed by educational professor

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Department of Medicine

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength	Isokinetic muscle strength	16 weeks	No
Secondary	Disease Activity Score (DAS28)	To evaluate the disease activity in rheumatoid arthritis	16 weeks	No
Secondary	Health Assessment Questionnaire (HAQ)	To measure the impact of funcional capacity in patients with rheumatoid arthritis	16 weeks	No
Secondary	Body composition measurements	Measures of body composition (lean and fat mass), by Dual-X ray absorptiometry (DXA)	16 weeks	No