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Completed

NCT Number: NCT05319964

Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziler Physical Therapy and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-gravity treadmill

Behavioral

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 treadmill

Behavioral

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.

Control

Behavioral

Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks.

Primary outcomes

  1. Visual Analogue Scale for Pain (VAS-pain)

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

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

Secondary outcomes

  1. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score

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

    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.

  2. Six-minute walk test (6MWT)

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

    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.

  3. Femoral cartilage thickness measurement with ultrasound

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

    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.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Comparison of Anti-gravity Treadmill Training and Traditional Treadmill Training in Patients With Moderate to Severe Knee Osteoarthritis

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 11, 2022
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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