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

July 31, 2016 updated by: André Serra Bley, University of Nove de Julho

Comparison Between a Land-based and Water-based Muscles Strengthening Program on Patients With Knee Osteoarthritis Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil
        • Universidade Nove de Julho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Land-based exercises
Land-based muscle strengthening exercises protocol
Other: land-based exercises
land-based exercise strengthening protocol for lower limb muscles
Experimental: Water-based exercises
Water-based muscle strengthening exercises protocol
Other: water-based exercises
water-based exercise strengthening protocol for lower limb muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function
Time Frame: 8 weeks
Pain and Function scores on the Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC questionnaire)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Performance
Time Frame: 8 weeks
Physical Performance scores on the Timed Up and GO test (TUG)
8 weeks
Strength muscle
Time Frame: 8 weeks
Strength muscle scores measured by heldheld dynamometer
8 weeks
Lower Limbs Function
Time Frame: 8 weeks
Function Scores on the Lower Extremity Functional Scale (LEFS)
8 weeks
Pain
Time Frame: 8 weeks
Pain Scores on the Numeric Pain Rating Scale
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Investigators

  • Principal Investigator: José Geraldo S Morelli, PhD student, University of Nove de Julho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 8, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 2, 2016

Last Update Submitted That Met QC Criteria

July 31, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Nove de Julho

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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