Knee OsteoarthritisNCT05319964
Anti-gravity Treadmill Training in Patients With Knee Osteoarthritis
A study testing Anti-gravity treadmill and Conventional treadmill in people with Knee Osteoarthritis, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Anti-gravity treadmill and Conventional treadmill
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2022to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Therapy and Rehabilitation Education and Research Hospital
Ankara
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Anti-gravity treadmill, Conventional treadmill, Control
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-gravity treadmillBehavioural
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 treadmillBehavioural
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.
ControlBehavioural
Patients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start5 Apr 2022
- Primary completion5 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Atan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319964
- Sponsor's protocol ID
- E2-21-1004
- Status last verified
- Jun 2024
- First submitted
- 28 Mar 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39482393
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-gravity Treadmill Training and Traditional Treadmill Training in Patients With Moderate to Severe Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05319964
- Acronym / sponsor ID
- E2-21-1004
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anti-gravity treadmill | Experimental | Behavioral: Anti-gravity treadmillPatients 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 | Active comparator | Behavioral: Conventional treadmillPatients 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 | Other | Behavioral: ControlPatients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-gravity treadmillPatients 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 | Behavioural | anti-gravity treadmill |
| Conventional treadmillPatients 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. | Behavioural | conventional treadmill |
| ControlPatients in all three study groups will receive hot pack, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound 3 days a week for 8 weeks. | Behavioural | Control |
Primary outcome
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.
3 secondary outcomes
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score
Time frame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks
Six-minute walk test (6MWT)
Time frame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks
Femoral cartilage thickness measurement with ultrasound
Time frame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Derived from this study: PubMed 39482393Atan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-gravity treadmill and Conventional treadmill in people with Knee Osteoarthritis, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Pain (VAS-pain) (time frame: Baseline - Change from Baseline at 4 weeks - Change from Baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05319964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.