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Effectiveness of Water Exercises on Isokinetic Muscle Strength

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Land exercises
Water exercises
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Muscle strength, Body composition, Physical activity, Water exercises, Hydrotherapy, Randomized controlled clinical trial

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

No Intervention

Arm Label

Land exercises

Water exercises

Control group

Arm Description

The patients of this group will perform the same exercises from water exercises

The patients of this group will perform the same exercises from land exercises

No intervention will be recommended

Outcomes

Primary Outcome Measures

Muscle strength
Isokinetic muscle strength

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2011
Last Updated
October 5, 2011
Sponsor
Federal University of São Paulo
Collaborators
Department of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01447264
Brief Title
Effectiveness of Water Exercises on Isokinetic Muscle Strength
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Department of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: 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? 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?
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, Muscle strength, Body composition, Physical activity, Water exercises, Hydrotherapy, Randomized controlled clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Land exercises
Arm Type
Placebo Comparator
Arm Description
The patients of this group will perform the same exercises from water exercises
Arm Title
Water exercises
Arm Type
Active Comparator
Arm Description
The patients of this group will perform the same exercises from land exercises
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be recommended
Intervention Type
Procedure
Intervention Name(s)
Land exercises
Intervention Description
3 times a week. 50 minutes in every session. Performed by educational professor
Intervention Type
Procedure
Intervention Name(s)
Water exercises
Intervention Description
3 times a week. 50 minutes in every session. Performed by educational professor
Primary Outcome Measure Information:
Title
Muscle strength
Description
Isokinetic muscle strength
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Disease Activity Score (DAS28)
Description
To evaluate the disease activity in rheumatoid arthritis
Time Frame
16 weeks
Title
Health Assessment Questionnaire (HAQ)
Description
To measure the impact of funcional capacity in patients with rheumatoid arthritis
Time Frame
16 weeks
Title
Body composition measurements
Description
Measures of body composition (lean and fat mass), by Dual-X ray absorptiometry (DXA)
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo M Pinheiro, MD, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04042033
Country
Brazil

12. IPD Sharing Statement

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Effectiveness of Water Exercises on Isokinetic Muscle Strength

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