Knee OsteoarthritisNCT05728827
A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis
A study testing Blood flow restriction training + Anti-gravity treadmill and Anti-gravity treadmill in people with Knee Osteoarthritis, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
Trial summary
The aim of this randomized controlled study is to investigate whether the implementation of Blood Flow Restriction, in which the de-loading factor is delivered by the combined progressive de-loaded walking to running activity on an antigravity treadmill (treatment group), is more effective than the same antigravity… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Blood flow restriction training + Anti-gravity treadmill and Anti-gravity treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Mar 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age included between 45 and 80 years old
- Patients with knee OA diagnosed by a medical doctor with a radiological confirmation
- Patients able to provide informed consent and follow all the study procedures as indicated by the protocol
- Informed Consent as documented by signature
Who cannot join
- Younger than 44 years old or older than 81 years old included
- Known drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- Participation in another study with an investigational drug within the 30 days preceding and during the present study
- Treatment with an injective approach in the previous 3 month
- Surgical treatment in the previous 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation With Blood Flow Restriction Training to Enhance Anti-gravity Treadmill Effects in the Treatment of Patients With Knee Osteoarthritis: a Randomized Controlled Trial
The aim of this randomized controlled study is to investigate whether the implementation of Blood Flow Restriction, in which the de-loading factor is delivered by the combined progressive de-loaded walking to running activity on an antigravity treadmill (treatment group), is more effective than the same antigravity protocol alone (control group).
Participants will be divided as follows:
Intervention group: anti-gravity treadmill combined with blood flow restriction Control group: anti-gravity treadmill Both groups will also undergo a standardized knee Osteoarthritis management through an aerobic and strength program.
- Conditions
- Knee Osteoarthritis
- Being tested
- Blood flow restriction training + Anti-gravity treadmill, Anti-gravity treadmill
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction training + Anti-gravity treadmillOther
Blood flow restriction training is administered via straps applied to the proximal limb with the possibility to adjust the applied occlusion pressure in order to prevent venous return leaving the arterial flow partially free. The consequent blood pooling causes a reduction in tissue saturation with oxidative stress and an increased growth factors secretion. The intervention will be applied while walking/running on the anti-gravity treadmill.
Anti-gravity treadmillOther
The intervention will be applied walking/running on the anti-gravity treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Anti-gravity treadmill + Blood Flow Restriction training | Experimental | Not described Receives: Other: Blood flow restriction training + Anti-gravity treadmill |
| Anti-gravity treadmill | Active comparator | Not described Receives: Other: Anti-gravity treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index
Questionnaire at baseline (day 1) and 6 weeks, and at 3, 6 months. The WOMAC questionnaire is composed of 3 sub-scores that evaluate pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points), and function (17 questions, 0-68 points) and is a validated patient-reported outcome measure (PROM) to evaluate knee osteoarthritis.
Measured: Change from Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start15 Mar 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Candrian, MD, Study chair, EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728827
- Sponsor's protocol ID
- ORL-ORT-39
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation With Blood Flow Restriction Training to Enhance Anti-gravity Treadmill Effects in the Treatment of Patients With Knee Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05728827
- Acronym / sponsor ID
- ORL-ORT-39
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Feb 2023 (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 randomized controlled study is to investigate whether the implementation of Blood Flow Restriction, in which the de-loading factor is delivered by the combined progressive de-loaded walking to running activity on an antigravity treadmill (treatment group), is more effective than the same antigravity protocol alone (control group).
Participants will be divided as follows:
Intervention group: anti-gravity treadmill combined with blood flow restriction Control group: anti-gravity treadmill Both groups will also undergo a standardized knee Osteoarthritis management through an aerobic and strength program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-gravity treadmill + Blood Flow Restriction training | Experimental | Other: Blood flow restriction training + Anti-gravity treadmill |
| Anti-gravity treadmill | Active comparator | Other: Anti-gravity treadmill |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age included between 45 and 80 years old
- Patients with knee OA diagnosed by a medical doctor with a radiological confirmation
- Patients able to provide informed consent and follow all the study procedures as indicated by the protocol
- Informed Consent as documented by signature
Key exclusion criteria (6 listed)
- Younger than 44 years old or older than 81 years old included
- Known drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- Participation in another study with an investigational drug within the 30 days preceding and during the present study
- Treatment with an injective approach in the previous 3 month
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 |
|---|---|---|
| Blood flow restriction training + Anti-gravity treadmillBlood flow restriction training is administered via straps applied to the proximal limb with the possibility to adjust the applied occlusion pressure in order to prevent venous return leaving the arterial flow partially free. The consequent blood pooling causes a reduction in tissue saturation with oxidative stress and an increased growth factors secretion. The intervention will be applied while walking/running on the anti-gravity treadmill. | Other | Anti-gravity treadmill + Blood Flow Restriction training |
| Anti-gravity treadmillThe intervention will be applied walking/running on the anti-gravity treadmill. | Other | Anti-gravity treadmill |
Primary outcome
Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index
Time frame: Change from Baseline to 6 months
Questionnaire at baseline (day 1) and 6 weeks, and at 3, 6 months. The WOMAC questionnaire is composed of 3 sub-scores that evaluate pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points), and function (17 questions, 0-68 points) and is a validated patient-reported outcome measure (PROM) to evaluate knee osteoarthritis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- 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.
Christian Candrian, MD study chair
EOC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction training + Anti-gravity treadmill and Anti-gravity treadmill in people with Knee Osteoarthritis, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index (time frame: Change from Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.