Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

N/ACompletedNCT05319964

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital30 enrolled

Overview

The aim of this study is to compare anti-gravity treadmill training with traditional treadmill training in patients with moderate to severe knee osteoarthritis.

Patients with moderate to severe OA have persistent pain that significantly affects their functional status, activity participation, and quality of life. As with mild OA, non-pharmacological interventions that focus on education, exercise, and weight management are first-line treatments for patients with moderate to severe knee OA. Exercise is recommended for all patients with moderate to severe knee OA to reduce pain and protect the joint. A meta-analysis showed that exercise has beneficial effects on pain, even in patients with severe disease and awaiting total knee replacement.Therefore, the objective of this study was to compare the effects of anti-gravity treadmill training and traditional treadmill training on pain levels, quality of life and functional capacity in patients with moderate and severe knee osteoarthritis. In addition, it was aimed to compare the compliance of the patients to aerobic exercise.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Anti-gravity treadmillBEHAVIORAL

Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, 3 days a week for 8 weeks. Participants were provided 30 minutes anti-gravity treadmill sessions including a 5 minutes warm - up and cool - down period for each session, 3 days a week, for 8 weeks

Conventional treadmillBEHAVIORAL

Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks. The moderate-intensity aerobic exercise program will be performed for 30 minutes at an intensity of 65-80% of the maximum heart rate, consisting of a 5-minute warm-up and cool-down period.

ControlBEHAVIORAL

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients ≥ 50 and ≤ 75 years old * Patients with a diagnosis of knee OA in at least one knee according to the classification criteria of the American College of Rheumatology * Patients with Kellgren-Lawrence (K-L) knee OA staging III to IV * Patients reporting knee pain on most days of the past month * Patients with stable medical and psychological status * Patients willing to participate in the study Exclusion Criteria: Patients with serious cardiovascular, pulmonary, neurological disease or other musculoskeletal problems (inflammatory rheumatic disease, active synovitis, severe low back pain, hip/knee joint replacement or other hip/knee-related trauma, fracture, or surgery) that impair walking * Patients with a history of corticosteroid injection to the knee in the last 3 months * Patients who have received opioid analgesics or systemic corticosteroids in the last 3 months * Patients who have undergone any exercise program or physical therapy program for the lower extremities in the last 3 months * Patients with severe vision, hearing and language problems * Patients with a body mass index ≥35 kg /m²

Locations (1)

Gaziler Physical Therapy and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Visual Analogue Scale for Pain (VAS-pain)

Pain intensity will be evaluated with a visual analog scale (0-10mm) that has proven validity and reliability to measure musculoskeletal pain.

Time frame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks

Secondary Outcomes

WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score

It measures knee pain, stiffness, and physical function. Scores for each subscale are summed with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. The sum of the scores of the three subscales gives the WOMAC score. High scores are associated with more pain, stiffness, and dysfunction, while low scores indicate well-being.

Time frame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks

Six-minute walk test (6MWT)

The 6 Minute Walk Test is a submaximal exercise test that usually corresponds to 80% of a person's maximum heart rate and is used to evaluate functional capacity and treatment response.

Time frame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks

Femoral cartilage thickness measurement with ultrasound

Distal femoral cartilage thickness will be evaluated by the same investigator, blinded to the patient treatment groups, using an ultrasound device with a 7.5-12 MHz linear transducer (LOGIQ 7 Pro; GE Yokogawa Medical System, Tokyo, Japan) available in our clinic.

Time frame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.