Effectiveness of Water Exercises on Isokinetic Muscle Strength

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.

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?

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Procedure: Land exercises; Procedure: Water exercises

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04042033
      • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Land exercises; The patients of this group will perform the same exercises from water exercises	Procedure: Land exercises; 3 times a week. 50 minutes in every session. Performed by educational professor
Active Comparator: Water exercises; The patients of this group will perform the same exercises from land exercises	Procedure: Water exercises; 3 times a week. 50 minutes in every session. Performed by educational professor
No Intervention: Control group; No intervention will be recommended

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Isokinetic muscle strength	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Score (DAS28)	To evaluate the disease activity in rheumatoid arthritis	16 weeks
Health Assessment Questionnaire (HAQ)	To measure the impact of funcional capacity in patients with rheumatoid arthritis	16 weeks
Body composition measurements	Measures of body composition (lean and fat mass), by Dual-X ray absorptiometry (DXA)	16 weeks

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Department of Medicine
• Investigators: Principal Investigator: Marcelo M Pinheiro, MD, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 6, 2011

Study Record Updates

• Last Update Posted (Estimate): October 6, 2011
• Last Update Submitted That Met QC Criteria: October 5, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Physical activity; Body composition; Rheumatoid arthritis; Muscle strength; Randomized controlled clinical trial; Hydrotherapy; Water exercises
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: FUSaoPaulo-01