Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Conventional treadmill; Behavioral: Control; Behavioral: Anti-gravity treadmill

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gaziler Physical Therapy and Rehabilitation Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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. 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. 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.
Other: 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	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.
Experimental: 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. 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. 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

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 10, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: E2-21-1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No