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Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Anti-gravity treadmill
Conventional treadmill
Control
Sponsored by
Hitit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 II 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

Sites / Locations

  • Gaziler Physical Therapy and Rehabilitation Education and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

anti-gravity treadmill

conventional treadmill

Control

Arm Description

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 30% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 3 days a week, for 8 weeks

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Short Form Health Survey 36 (SF-36)
SF-36 includes 36 items used to assess the quality of life of patients with chronic pain. It measures eight different domains that address physical function, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score for each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
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.
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.

Full Information

First Posted
March 28, 2022
Last Updated
January 27, 2023
Sponsor
Hitit University
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1. Study Identification

Unique Protocol Identification Number
NCT05319964
Brief Title
Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis
Official Title
Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study was to compare the effects of anti-gravity treadmill training and traditional treadmill training treatments combined with strengthening exercises on patients' pain levels, quality of life, distal femoral cartilage thickness, and functional capacity in patients with moderate and severe knee OA. In addition, it was aimed to compare the compliance of the patients to aerobic exercise.
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. The aim of this study was to compare the effects of anti-gravity treadmill training and traditional treadmill training treatments combined with strengthening exercises on patients' pain levels, quality of life, distal femoral cartilage thickness, and functional capacity in patients with moderate and severe knee OA. In addition, it was aimed to compare the compliance of the patients to aerobic exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-gravity treadmill
Arm Type
Experimental
Arm Description
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 30% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 3 days a week, for 8 weeks
Arm Title
conventional treadmill
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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
Intervention Name(s)
Anti-gravity treadmill
Intervention Description
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 30% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 3 days a week, for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Conventional treadmill
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
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 Outcome Measure Information:
Title
Visual Analogue Scale for Pain (VAS-pain)
Description
Pain intensity will be evaluated with a visual analog scale (0-10mm) that has proven validity and reliability to measure musculoskeletal pain.
Time Frame
Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks
Secondary Outcome Measure Information:
Title
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score
Description
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.
Time Frame
Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks
Title
Short Form Health Survey 36 (SF-36)
Description
SF-36 includes 36 items used to assess the quality of life of patients with chronic pain. It measures eight different domains that address physical function, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score for each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
Time Frame
Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks
Title
Six-minute walk test (6MWT)
Description
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.
Time Frame
Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks
Title
Femoral cartilage thickness measurement with ultrasound
Description
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.
Time Frame
Baseline - Change from Baseline at 4 weeks - Change from Baseline at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 II 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
Facility Information:
Facility Name
Gaziler Physical Therapy and Rehabilitation Education and Research Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuğba Atan
Phone
+90312 291 10 00
Email
tubaatan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis

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