Clinical trial NCT05319964: Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis
Official title: Comparison of Anti-gravity Treadmill Training and Traditional Treadmill Training in Patients With Moderate to Severe Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.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.

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 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

Primary outcomes:
measure: Visual Analogue Scale for Pain (VAS-pain)
timeFrame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks
Secondary outcomes:
measure: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score
timeFrame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks
measure: Six-minute walk test (6MWT)
timeFrame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks
measure: Femoral cartilage thickness measurement with ultrasound
timeFrame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Therapy and Rehabilitation Education and Research Hospital
Study officials:
References: