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

Sponsor
University of Nove de Julho (Other)
Overall Status
Completed
CT.gov ID
NCT02295605
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
15
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: water-based exercises
  • Other: land-based exercises
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison Between a Land-based and Water-based Muscles Strengthening Program on Patients With Knee Osteoarthritis Randomized Controlled Trial
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Function [8 weeks]

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

Secondary Outcome Measures

  1. Physical Performance [8 weeks]

    Physical Performance scores on the Timed Up and GO test (TUG)

  2. Strength muscle [8 weeks]

    Strength muscle scores measured by heldheld dynamometer

  3. Lower Limbs Function [8 weeks]

    Function Scores on the Lower Extremity Functional Scale (LEFS)

  4. Pain [8 weeks]

    Pain Scores on the Numeric Pain Rating Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidade Nove de Julho São Paulo SP Brazil

Sponsors and Collaborators

  • University of Nove de Julho

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
André Serra Bley, PhD student, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT02295605
Other Study ID Numbers:
  • University of Nove de Julho
First Posted:
Nov 20, 2014
Last Update Posted:
Aug 2, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee

Study Results

No Results Posted as of Aug 2, 2016