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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295605
• Other study ID #: University of Nove de Julho
• Status: Completed
• Phase: Phase 1
• First received: November 8, 2014
• Last updated: July 31, 2016
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• water-based exercises
water-based exercise strengthening protocol for lower limb muscles
• land-based exercises
land-based exercise strengthening protocol for lower limb muscles

Locations

Country	Name	City	State
Brazil	Universidade Nove de Julho	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function	Pain and Function scores on the Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC questionnaire)	8 weeks	Yes
Secondary	Physical Performance	Physical Performance scores on the Timed Up and GO test (TUG)	8 weeks	Yes
Secondary	Strength muscle	Strength muscle scores measured by heldheld dynamometer	8 weeks	Yes
Secondary	Lower Limbs Function	Function Scores on the Lower Extremity Functional Scale (LEFS)	8 weeks	Yes
Secondary	Pain	Pain Scores on the Numeric Pain Rating Scale	8 weeks	Yes