An interventional study of Anti-gravity treadmill and Conventional treadmill in Knee Osteoarthritis, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Gaziler Physical Medicine and Rehabilitation Education and Research Hospital is the lead sponsor of 80 studies on the registry; 10 are open to participants now.
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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 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
Behavioral: Anti-gravity treadmill
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
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
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
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.
Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks.
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
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
Plan to share: No
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital