Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

NCT05319964 | Completed

• 1 other identifier: E2-21-1004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 8 weeks

Secondary Outcomes (3)

• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score

  Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks

• Six-minute walk test (6MWT)

  Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks

• Femoral cartilage thickness measurement with ultrasound

  Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks

Study Arms (3)

anti-gravity treadmill

EXPERIMENTAL

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

conventional treadmill

ACTIVE COMPARATOR

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

Control

OTHER

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

Interventions

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

anti-gravity treadmill

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.

conventional treadmill

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.

Control

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Therapy and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Atan T, Bildik YE, Demir Y, Guzelkucuk U, Tan AK. Comparison of anti-gravity treadmill training and traditional treadmill training in patients with moderate to severe knee osteoarthritis: A randomized controlled trial. Ir J Med Sci. 2025 Feb;194(1):125-136. doi: 10.1007/s11845-024-03836-w. Epub 2024 Nov 1.

  PMID: 39482393 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 11, 2022
• Study Start: April 5, 2022
• Primary Completion: February 5, 2024
• Study Completion: February 10, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)