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Comparison Between Land-based and Water-based Exercises for Knee Osteoarthritis: Randomized Controlled Trial

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
water-based exercises
land-based exercises
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate knee osteoarthritis (grade 2 or 3 using the Kellgren-Lawrence radiograph classification), diagnosed based on clinical and radiological criteria of the American College of Rheumatology
  • No other lower limb and spine musculoskeletal disorders
  • Independent gait
  • Body mass index below 32
  • Minimum of 4 points in the pain numeric rating scale during climb and descend stairs activities

Exclusion Criteria:

  • Cognitive or psychological disorders
  • Neurological disorders
  • History of post-traumatic knee osteoarthritis
  • Knee pain at least 12 months
  • Prior surgery of the lower limbs or spine
  • Fibromyalgia
  • Rheumatoid arthritis
  • Cardiovascular disease
  • Participating in exercise programs and received treatment for the knee at least 3 months

Sites / Locations

  • Universidade Nove de Julho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Land-based exercises

Water-based exercises

Arm Description

Land-based muscle strengthening exercises protocol

Water-based muscle strengthening exercises protocol

Outcomes

Primary Outcome Measures

Function
Pain and Function scores on the Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC questionnaire)

Secondary Outcome Measures

Physical Performance
Physical Performance scores on the Timed Up and GO test (TUG)
Strength muscle
Strength muscle scores measured by heldheld dynamometer
Lower Limbs Function
Function Scores on the Lower Extremity Functional Scale (LEFS)
Pain
Pain Scores on the Numeric Pain Rating Scale

Full Information

First Posted
November 8, 2014
Last Updated
July 31, 2016
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02295605
Brief Title
Comparison Between Land-based and Water-based Exercises for Knee Osteoarthritis: Randomized Controlled Trial
Official Title
Comparison Between a Land-based and Water-based Muscles Strengthening Program on Patients With Knee Osteoarthritis Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function and strength.
Detailed Description
Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function, physical performance and strength.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Land-based exercises
Arm Type
Experimental
Arm Description
Land-based muscle strengthening exercises protocol
Arm Title
Water-based exercises
Arm Type
Experimental
Arm Description
Water-based muscle strengthening exercises protocol
Intervention Type
Other
Intervention Name(s)
water-based exercises
Intervention Description
water-based exercise strengthening protocol for lower limb muscles
Intervention Type
Other
Intervention Name(s)
land-based exercises
Intervention Description
land-based exercise strengthening protocol for lower limb muscles
Primary Outcome Measure Information:
Title
Function
Description
Pain and Function scores on the Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC questionnaire)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Physical Performance
Description
Physical Performance scores on the Timed Up and GO test (TUG)
Time Frame
8 weeks
Title
Strength muscle
Description
Strength muscle scores measured by heldheld dynamometer
Time Frame
8 weeks
Title
Lower Limbs Function
Description
Function Scores on the Lower Extremity Functional Scale (LEFS)
Time Frame
8 weeks
Title
Pain
Description
Pain Scores on the Numeric Pain Rating Scale
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate knee osteoarthritis (grade 2 or 3 using the Kellgren-Lawrence radiograph classification), diagnosed based on clinical and radiological criteria of the American College of Rheumatology No other lower limb and spine musculoskeletal disorders Independent gait Body mass index below 32 Minimum of 4 points in the pain numeric rating scale during climb and descend stairs activities Exclusion Criteria: Cognitive or psychological disorders Neurological disorders History of post-traumatic knee osteoarthritis Knee pain at least 12 months Prior surgery of the lower limbs or spine Fibromyalgia Rheumatoid arthritis Cardiovascular disease Participating in exercise programs and received treatment for the knee at least 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Geraldo S Morelli, PhD student
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Nove de Julho
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison Between Land-based and Water-based Exercises for Knee Osteoarthritis: Randomized Controlled Trial

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