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

NCT ID: NCT02295605

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-11-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Land-based exercises

Land-based muscle strengthening exercises protocol

Group Type: EXPERIMENTAL

land-based exercises

Intervention Type: OTHER

land-based exercise strengthening protocol for lower limb muscles

Water-based exercises

Water-based muscle strengthening exercises protocol

Group Type: EXPERIMENTAL

water-based exercises

Intervention Type: OTHER

water-based exercise strengthening protocol for lower limb muscles

Interventions

water-based exercises

water-based exercise strengthening protocol for lower limb muscles

Intervention Type: OTHER

land-based exercises

land-based exercise strengthening protocol for lower limb muscles

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

André Serra Bley

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Geraldo S Morelli, PhD student

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

Universidade Nove de Julho

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

University of Nove de Julho

Identifier Type: -

Identifier Source: org_study_id