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NCT Number: NCT02295605

Comparison Between Land-based and Water-based Exercises for 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universidade Nove de Julho

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

water-based exercises

Other

water-based exercise strengthening protocol for lower limb muscles

land-based exercises

Other

land-based exercise strengthening protocol for lower limb muscles

Primary outcomes

  1. Function

    Time frame: 8 weeks

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

Secondary outcomes

  1. Physical Performance

    Time frame: 8 weeks

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

  2. Strength muscle

    Time frame: 8 weeks

    Strength muscle scores measured by heldheld dynamometer

  3. Lower Limbs Function

    Time frame: 8 weeks

    Function Scores on the Lower Extremity Functional Scale (LEFS)

  4. Pain

    Time frame: 8 weeks

    Pain Scores on the Numeric Pain Rating Scale

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2014
Registry last updated
Aug 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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