Knee OsteoarthritisBFROANCT05274932
Exercise With Blood Flow Restriction in Knee Osteoarthritis
A study testing BFR resistance exercise in people with Knee Osteoarthritis, run by University of Valencia at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the neuromuscular responses, pain intensity and rate of perceived exertion in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with blood flow restriction at different levels of arterial occlusion pressure. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- BFR resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 21 Mar 2022to 20 May 2022
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women above 55 years old.
- diagnosed with severe knee osteoarthritis.
- scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.
Who cannot join
- pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a VAS during daily activities).
- another hip or knee joint replacement in the previous year.
- any medical condition in which exercise was contraindicated.
- participated in exercise programs (>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study.
- history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Responses, Pain Intensity and Perceived Exertion of Resistance Exercise With Blood Flow Restriction in Patients With Severe Knee Osteoarthritis
The purpose of this study is to evaluate the neuromuscular responses, pain intensity and rate of perceived exertion in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with blood flow restriction at different levels of arterial occlusion pressure.
- Conditions
- Knee Osteoarthritis
- Being tested
- BFR resistance exercise
- Keywords
- Knee Osteoarthritis, Electromyography, Muscle Activity, Resistance Training
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR resistance exerciseOther
4 sets (30, 15, 15, 15 reps).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Active comparator | Knee extensions with 30% 1RM and no occlusion pressure. Receives: Other: BFR resistance exercise |
| BFR at 40% AOP | Experimental | Knee extensions with 30% 1RM and BFR at 40% AOP. Receives: Other: BFR resistance exercise |
| BFR at 80% AOP | Experimental | Knee extensions with 30% 1RM and BFR at 80% AOP. Receives: Other: BFR resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Change from baseline to the end of the session, and the change between the treatment group and the placebo group.
Measured: Pre exercise, immediate post set, immediate post session, and 10 minutes after session.
Pressure pain thresholds
Change from baseline to the end of the session, and the change between the treatment group and the placebo group.
Measured: Pre exercise, immediate post session, and 10 minutes after session.
HDsEMG
Change between baseline and exercise, and the change between the treatment group and the placebo group.
Measured: During each experimental session and during each exercise condition.
Secondary outcomes (6)
Tampa Scale of Kinesiophobia (TSK 11)
Its score range is 11-44, with higher scores reflecting worse condition.
Measured: Pre session.
Pain Catastrophizing Scale (PCS)
People are asked to indicate the degree to which they have certain thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness, with higher scores reflecting worse condition.
Measured: Pre session.
Chronic Pain Self-Efficacy Scale (CPSS)
The Chronic Pain Self-Efficacy Scale (CPSS) is designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain. The CPSS measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. A total score is yielded (ranging from 220-2200), with higher scores reflecting a better condition.
Measured: Pre session.
WOMAC questionaire for patients with hip or knee osteoarthritis.
The WOMAC is a disease-specific self-administered questionnaire for patients with hip or knee osteoarthritis. It has a multidimensional scale made up of 24 items grouped into three dimensions: pain (5 items), stiffness (2 items) and physical function (17 items). For each item, it uses a Likert scale with five response levels, representing different degrees of intensity (none, mild, moderate, severe or extreme) that are scored from 0 to 4. The final score for the WOMAC is determined by adding the aggregate scores for pain, stiffness and function. The higher the score, the worse the patient's condition.
Measured: Pre session.
Heart Rate
Change from baseline to the end of the session, and the change between the treatment group and the placebo group.
Measured: Pre exercise, immediate post set, immediate post session, and 10 minutes after session.
Rating of perceived exertion (RPE) based on Borg's CR10 scale
The Borg CR10 scale is a tool for measuring an individual's effort and exertion during physical work. It is a very simple numerical list from 0 (no exertion at all) to 10 (maximal intensity of activity). Participants are asked to rate their exertion on the scale during the activity, combining all sensations and feelings of physical stress and fatigue. They are told to disregard any one factor such as leg pain or shortness of breath but to try to focus on the whole feeling of exertion.
Measured: Immediate post exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start21 Mar 2022
- Primary completion13 May 2022
- Study completion20 May 2022
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.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Casaña Granell, University of Valencia
- Investigators
- José Casaña, Principal investigator, University of ValenciaJoaquín Calatayud, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274932
- Sponsor's protocol ID
- OA-22-01
- Acronym
- BFROA
- Status last verified
- May 2022
- First submitted
- 15 Feb 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ogrezeanu DC, Lopez-Bueno L, Sanchis-Sanchez E, Carrasco JJ, Cuenca-Martinez F, Suso-Marti L, Lopez-Bueno R, Cruz-Montecinos C, Martinez-Valdes E, Casana J, Calatayud J. Neuromuscular Responses and Perceptions of Health Status and Pain-Related Constructs in End-Stage Knee Osteoarthritis During Resistance Training With Blood Flow Restriction. J Strength Cond Res. 2024 Apr 1;38(4):762-772. doi: 10.1519/JSC.0000000000004680. Epub 2023 Dec 13.
PubMed 38090743
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Responses, Pain Intensity and Perceived Exertion of Resistance Exercise With Blood Flow Restriction in Patients With Severe Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05274932
- Acronym / sponsor ID
- BFROA / OA-22-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Electromyography, Muscle Activity, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 11 Mar 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 purpose of this study is to evaluate the neuromuscular responses, pain intensity and rate of perceived exertion in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with blood flow restriction at different levels of arterial occlusion pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Active comparator | Other: BFR resistance exerciseKnee extensions with 30% 1RM and no occlusion pressure. |
| BFR at 40% AOP | Experimental | Other: BFR resistance exerciseKnee extensions with 30% 1RM and BFR at 40% AOP. |
| BFR at 80% AOP | Experimental | Other: BFR resistance exerciseKnee extensions with 30% 1RM and BFR at 80% AOP. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women above 55 years old.
- diagnosed with severe knee osteoarthritis.
- scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.
Key exclusion criteria (5 listed)
- pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a VAS during daily activities).
- another hip or knee joint replacement in the previous year.
- any medical condition in which exercise was contraindicated.
- participated in exercise programs (>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study.
- history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.
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 |
|---|---|---|
| BFR resistance exercise4 sets (30, 15, 15, 15 reps). | Other | BFR at 40% AOP, BFR at 80% AOP, Placebo |
Primary outcome
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Time frame: Pre exercise, immediate post set, immediate post session, and 10 minutes after session.
Change from baseline to the end of the session, and the change between the treatment group and the placebo group.
Pressure pain thresholds
Time frame: Pre exercise, immediate post session, and 10 minutes after session.
Change from baseline to the end of the session, and the change between the treatment group and the placebo group.
HDsEMG
Time frame: During each experimental session and during each exercise condition.
Change between baseline and exercise, and the change between the treatment group and the placebo group.
6 secondary outcomes
Tampa Scale of Kinesiophobia (TSK 11)
Time frame: Pre session.
Pain Catastrophizing Scale (PCS)
Time frame: Pre session.
Chronic Pain Self-Efficacy Scale (CPSS)
Time frame: Pre session.
WOMAC questionaire for patients with hip or knee osteoarthritis.
Time frame: Pre session.
Heart Rate
Time frame: Pre exercise, immediate post set, immediate post session, and 10 minutes after session.
Rating of perceived exertion (RPE) based on Borg's CR10 scale
Time frame: Immediate post exercise.
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 24 May 2022.
- Derived from this study: PubMed 38090743Ogrezeanu DC, Lopez-Bueno L, Sanchis-Sanchez E, Carrasco JJ, Cuenca-Martinez F, Suso-Marti L, Lopez-Bueno R, Cruz-Montecinos C, Martinez-Valdes E, Casana J, Calatayud J. Neuromuscular Responses and Perceptions of Health Status and Pain-Related Constructs in End-Stage Knee Osteoarthritis During Resistance Training With Blood Flow Restriction. J Strength Cond Res. 2024 Apr 1;38(4):762-772. doi: 10.1519/JSC.0000000000004680. Epub 2023 Dec 13.
- 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.
José Casaña principal investigator
University of Valencia
Joaquín Calatayud study chair
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR resistance exercise in people with Knee Osteoarthritis, run by University of Valencia at 1 site in Spain.
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 3 inclusion and 5 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 24 May 2022. 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 Spain. 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?
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10) (time frame: Pre exercise, immediate post set, immediate post session, and 10 minutes after session.). The study lists 3 primary outcomes in all. 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 NCT05274932, 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 24 May 2022.