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Effectiveness of Water Exercises on Isokinetic Muscle Strength

This study has been completed.
Sponsor:
Collaborator:
Department of Medicine
Information provided by (Responsible Party):
Marcelo M Pinheiro, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01447264
First received: October 3, 2011
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
  Purpose

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?

Condition Intervention Phase
Rheumatoid Arthritis
 Procedure: Land exercises
Procedure: Water exercises
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Muscle strength [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Isokinetic muscle strength


Secondary Outcome Measures:
  • Disease Activity Score (DAS28) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    To evaluate the disease activity in rheumatoid arthritis

  • Health Assessment Questionnaire (HAQ) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    To measure the impact of funcional capacity in patients with rheumatoid arthritis

  • Body composition measurements [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Measures of body composition (lean and fat mass), by Dual-X ray absorptiometry (DXA)


Enrollment: 100
Study Start Date: February 2009
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447264

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04042033
Sponsors and Collaborators
Federal University of São Paulo
Department of Medicine
Investigators
Principal Investigator: Marcelo M Pinheiro, MD, PhD Federal University of Sao Paulo
  More Information

No publications provided

Responsible Party: Marcelo M Pinheiro, Clinical Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01447264     History of Changes
Other Study ID Numbers: FUSaoPaulo-01
Study First Received: October 3, 2011
Last Updated: October 5, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Rheumatoid arthritis
Muscle strength
Body composition
Physical activity
 Water exercises
Hydrotherapy
Randomized controlled clinical trial

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013