Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare the effects of anti-gravity treadmill training and traditional treadmill training treatments combined with strengthening exercises on patients' pain levels, quality of life, distal femoral cartilage thickness, and functional capacity in patients with moderate and severe knee OA. In addition, it was aimed to compare the compliance of the patients to aerobic exercise.

Detailed Description
-----------------
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. The aim of this study was to compare the effects of anti-gravity treadmill training and traditional treadmill training treatments combined with strengthening exercises on patients' pain levels, quality of life, distal femoral cartilage thickness, and functional capacity in patients with moderate and severe knee OA. In addition, it was aimed to compare the compliance of the patients to aerobic exercise.

Official Title
-----------------
Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Behavioral: Anti-gravity treadmill
* Behavioral: Conventional treadmill
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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 II 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-gravity treadmill<br>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 30% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 3 days a week, for 8 weeks | Behavioral: Anti-gravity treadmill<br>* 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 30% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 3 days a week, for 8 weeks<br>|
| Active Comparator: conventional treadmill<br>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. | Behavioral: Conventional treadmill<br>* 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.<br>|
| Other: Control<br>Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks | Behavioral: Control<br>* Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks | 
| Short Form Health Survey 36 (SF-36) | SF-36 includes 36 items used to assess the quality of life of patients with chronic pain. It measures eight different domains that address physical function, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score for each domain ranges from 0 (worse quality of life) to 100 (best quality of life). | Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 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. | Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 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. | Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks |