Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

NCT ID: NCT05319964

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-05

Study Completion Date

2024-02-10

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Anti-gravity treadmill

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Conventional treadmill

Intervention Type 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

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

Group Type OTHER

Control

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tuğba Atan, MD

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gaziler Physical Therapy and Rehabilitation Education and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 39482393 (View on PubMed)

Other Identifiers

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E2-21-1004

Identifier Type: -

Identifier Source: org_study_id

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