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

NCT02295605 | Completed Phase 1 DMC

• 1 other identifier: University of Nove de Julho
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Function

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

  8 weeks

Secondary Outcomes (4)

• Physical Performance

  8 weeks

• Strength muscle

  8 weeks

• Lower Limbs Function

  8 weeks

• Pain

  8 weeks

Study Arms (2)

Land-based exercises

EXPERIMENTAL

Land-based muscle strengthening exercises protocol

Other: land-based exercises

Water-based exercises

EXPERIMENTAL

Water-based muscle strengthening exercises protocol

Other: water-based exercises

Interventions

water-based exercises OTHER

water-based exercise strengthening protocol for lower limb muscles

Water-based exercises

land-based exercises OTHER

land-based exercise strengthening protocol for lower limb muscles

Land-based exercises

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• José Geraldo S Morelli, PhD student

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: November 8, 2014
• First Posted: November 20, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 2, 2016

Record last verified: 2016-07

Locations

BR (1)