Total Knee ArthroplastyNCT05843773
Low-Load Blood Flow Restriction Training With Patients Who Underwent a Total Knee Arthroplasty: a Feasibility Trial
A study testing Low Load Strength Training under Blood Flow Restriction in people with Total Knee Arthroplasty, run by HES-SO Valais-Wallis at 1 site in Switzerland.
Trial summary
This project aims to investigate the feasibility of a low load (LL) isokinetic knee flexor and extensor strength training (ST) protocol under blood flow restriction (BFR) conditions in early postoperative total knee arthroplasty patients. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Low Load Strength Training under Blood Flow Restriction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 May 2023to 6 Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary TKA surgery less than 12 days before inclusion
- Ability to participate fully in physiotherapy
- Ability to consent for study participation
- Age between 50 and 80 years old
Who cannot join
- Postoperative complication
- History of deep venous thrombosis
- History of vascular pathology
- History of metabolic condition
- Previous contralateral TKA
- Previous ipsilateral or contralateral total hip arthroplasty
Show all 12Show fewer
- Any other lower extremity musculoskeletal chronic condition
- Any lower extremity injury within the last 6 months
- Pregnancy
- Sickle cell trait
- History of neurocognitive disorders
- Inability to follow the intervention protocol
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to investigate the feasibility of a low load (LL) isokinetic knee flexor and extensor strength training (ST) protocol under blood flow restriction (BFR) conditions in early postoperative total knee arthroplasty patients.
The intervention consists in testing an experimental strengthening protocol in the Leukerbad Clinic. 12 participants will be recruited and the intervention will last approximatively 3 weeks and will consist in 3 weekly ST.
The collected data will then be analysed and interpreted to define if such an intervention is feasible or not.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Low Load Strength Training under Blood Flow Restriction
- Keywords
- strength training, blood flow restriction, total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Load Strength Training under Blood Flow RestrictionProcedure or surgery
The first training includes one initiation/warm up set and two sets of normal training. Every set lasts 60 seconds and the patient is asked to bend and stretch the knee with a standard speed of 20°/s.
From the second to the ninth training, the patient will have one warm up set plus three trainings sets. The speed of execution will be increased every training.
The 20-40% range of the 1RM will be applied according to the values of the theoretical maximal strength.
If no strength progression is observed in the three last training sessions, the speed of execution will automatically be increased by 15°/s.
In order to keep the training intensity low and to not overload the knee, participants will be instructed to control the intensity with the Borg CR10. The volunteers will have to keep their efforts between 2/10 and 4/10. They will also be asked to stay in the range defined thanks to the theoretical maximal strength shown by the screen.
| Study group | Role | What they receive |
|---|---|---|
| Low Load Strength Training under Blood Flow Restriction | Experimental | Low Load Strength Training under blood flow restriction Receives: Procedure: Low Load Strength Training under Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Practicality of the study protocol - Time to teach the protocol to the personnel
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed to teach the protocol to the personnel in minutes
Measured: Before the beginning of the procedure
Practicality of the study protocol - Time needed for the pre-tests
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the pre-tests in minutes
Measured: Day 1 post-inclusion
Practicality of the study protocol - Time needed for the post-tests
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the post-tests in minutes; time needed for the intervention in minutes; human resources needed. We will also appraise the recruitment rates by evaluating the number of volunteers recruited within 6 months. We will then assess the retention rates by counting the number of dropouts and analysing the compliance/adherence rates. And finally, we will evaluate the costs by considering the equipment, recruitment, ethical commission, and human resources costs.
Measured: Day 1 post-inclusion
Practicality of the study protocol - Time needed for the post-tests
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the post-tests in minutes
Measured: Last day of the intervention
Practicality of the study protocol - Time needed for the intervention
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the intervention in minutes
Measured: During the procedure (approximatively 3 weeks long)
Practicality of the study protocol - Human ressources needed
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: human resources needed.
Measured: During the procedure (approximatively 3 weeks long)
Practicality of the study protocol - Recruitment rates
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: the recruitment rates by evaluating the number of volunteers recruited within 6 months.
Measured: During the recruitment period (6months)
Practicality of the study protocol - Retention rates
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: the retention rates by counting the number of dropouts and analysing the compliance/adherence rates. And finally, we will evaluate the costs by considering the equipment, recruitment, ethical commission, and human resources costs.
Measured: During the recruitment period (6months)
Practicality of the study protocol - Costs
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: the costs by considering the equipment, recruitment, ethical commission, and human resources costs.
Measured: From date of acceptation of the project (April 2022) to the anticipated end of the project (December 2023), assessed up to 90 weeks
Acceptability of the intervention
The domain acceptability focuses on how the individuals involved in the study react to the intervention (Bowen et al., 2009). We will assess both the satisfaction with the intervention protocols and the perceived positive and negative effects during and after the intervention protocols. Both outcomes will be evaluated with the visual analogue scale (VAS).
Measured: Up to three weeks (duration of the intervention)
Secondary outcomes (4)
Preliminary data on benefits - Strength
The domain preliminary data on benefits refers to the effect of the intervention protocol that we will measure. For the outcome strength, we will measure the maximal strength of the knee flexors and extensors. The data assessed will be described in Newton meter (Nm) and will be gathered on the isokinetic dynamometer.
Measured: During the procedure (approximatively 3 weeks long)
Preliminary data on benefits - Pain
The domain preliminary data on benefits refers to the effect of the intervention protocol that we will measure.
The outcome pain will be measured with the Visual Analogue Scale. We will ask the patient before, between and after every set what is the rating and analyse it in the end of the study.
Measured: During the procedure (approximatively 3 weeks long)
Preliminary data on benefits - Functionality
The domain preliminary data on benefits refers to the effect of the intervention protocol that we will measure.
The outcome functionality will be assessed with the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Measured: Up to three weeks (duration of the intervention)
Preliminary data on benefits - Functionality
The domain preliminary data on benefits refers to the effect of the intervention protocol that we will measure.
The second outcome for functionality will be assessed the 6 Minute Walk Test (6MWT).
Measured: Up to three weeks (duration of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 May 2023
- Primary completion15 Oct 2023
- Study completion6 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The present study is a feasibility study. The study is based on the Consort Checklist for pilot and feasibility trials. This will be a monocentric study; the patients will be recruited at the Leukerbad Clinic.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- HES-SO Valais-Wallis
- Sponsor type
- University, hospital or other
- Collaborators
- Leukerbad Clinic, Bern University of Applied Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843773
- Sponsor's protocol ID
- 2022-01102
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Load Blood Flow Restriction Training With Patients Who Underwent a Total Knee Arthroplasty: a Feasibility Trial
- ClinicalTrials.gov ID
- NCT05843773
- Acronym / sponsor ID
- 2022-01102
- Conditions
- Total Knee Arthroplasty
- Keywords
- strength training, blood flow restriction, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- HES-SO Valais-WallisUniversity, hospital or other
- Collaborators
- Leukerbad Clinic, Bern University of Applied Sciences
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 6 Jan 2024 (actual)
- First posted
- 6 May 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.
This project aims to investigate the feasibility of a low load (LL) isokinetic knee flexor and extensor strength training (ST) protocol under blood flow restriction (BFR) conditions in early postoperative total knee arthroplasty patients.
The intervention consists in testing an experimental strengthening protocol in the Leukerbad Clinic. 12 participants will be recruited and the intervention will last approximatively 3 weeks and will consist in 3 weekly ST.
The collected data will then be analysed and interpreted to define if such an intervention is feasible or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The present study is a feasibility study. The study is based on the Consort Checklist for pilot and feasibility trials. This will be a monocentric study; the patients will be recruited at the Leukerbad Clinic.
| Arm | Type | Receives |
|---|---|---|
| Low Load Strength Training under Blood Flow Restriction | Experimental | Procedure: Low Load Strength Training under Blood Flow RestrictionLow Load Strength Training under blood flow restriction |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary TKA surgery less than 12 days before inclusion
- Ability to participate fully in physiotherapy
- Ability to consent for study participation
- Age between 50 and 80 years old
Key exclusion criteria (12 listed)
- Postoperative complication
- History of deep venous thrombosis
- History of vascular pathology
- History of metabolic condition
- Previous contralateral TKA
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 |
|---|---|---|
| Low Load Strength Training under Blood Flow RestrictionThe first training includes one initiation/warm up set and two sets of normal training. Every set lasts 60 seconds and the patient is asked to bend and stretch the knee with a standard speed of 20°/s. From the second to the ninth training, the patient will have one warm up set plus three trainings sets. The speed of execution will be increased every training. The 20-40% range of the 1RM will be applied according to the values of the theoretical maximal strength. If no strength progression is observed in the three last training sessions, the speed of execution will automatically be increased by 15°/s. In order to keep the training intensity low and to not overload the knee, participants will be instructed to control the intensity with the Borg CR10. The volunteers will have to keep their efforts between 2/10 and 4/10. They will also be asked to stay in the range defined thanks to the theoretical maximal strength shown by the screen. | Procedure or surgery | Low Load Strength Training under Blood Flow Restriction |
Primary outcome
Practicality of the study protocol - Time to teach the protocol to the personnel
Time frame: Before the beginning of the procedure
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed to teach the protocol to the personnel in minutes
Practicality of the study protocol - Time needed for the pre-tests
Time frame: Day 1 post-inclusion
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the pre-tests in minutes
Practicality of the study protocol - Time needed for the post-tests
Time frame: Day 1 post-inclusion
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the post-tests in minutes; time needed for the intervention in minutes; human resources needed. We will also appraise the recruitment rates by evaluating the number of volunteers recruited within 6 months. We will then assess the retention rates by counting the number of dropouts and analysing the compliance/adherence rates. And finally, we will evaluate the costs by considering the equipment, recruitment, ethical commission, and human resources costs.
Practicality of the study protocol - Time needed for the post-tests
Time frame: Last day of the intervention
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the post-tests in minutes
Practicality of the study protocol - Time needed for the intervention
Time frame: During the procedure (approximatively 3 weeks long)
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: time needed for the intervention in minutes
Practicality of the study protocol - Human ressources needed
Time frame: During the procedure (approximatively 3 weeks long)
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: human resources needed.
Practicality of the study protocol - Recruitment rates
Time frame: During the recruitment period (6months)
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: the recruitment rates by evaluating the number of volunteers recruited within 6 months.
Practicality of the study protocol - Retention rates
Time frame: During the recruitment period (6months)
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: the retention rates by counting the number of dropouts and analysing the compliance/adherence rates. And finally, we will evaluate the costs by considering the equipment, recruitment, ethical commission, and human resources costs.
Practicality of the study protocol - Costs
Time frame: From date of acceptation of the project (April 2022) to the anticipated end of the project (December 2023), assessed up to 90 weeks
The term practicality refers to "the extent to which an intervention can be delivered when resources, time, commitment, or some combinations thereof are constrained in some way" (Bowen et al., 2009). We will therefore assess the ability of therapists to carry out the tests and intervention by evaluating the following variable: the costs by considering the equipment, recruitment, ethical commission, and human resources costs.
Acceptability of the intervention
Time frame: Up to three weeks (duration of the intervention)
The domain acceptability focuses on how the individuals involved in the study react to the intervention (Bowen et al., 2009). We will assess both the satisfaction with the intervention protocols and the perceived positive and negative effects during and after the intervention protocols. Both outcomes will be evaluated with the visual analogue scale (VAS).
4 secondary outcomes
Preliminary data on benefits - Strength
Time frame: During the procedure (approximatively 3 weeks long)
Preliminary data on benefits - Pain
Time frame: During the procedure (approximatively 3 weeks long)
Preliminary data on benefits - Functionality
Time frame: Up to three weeks (duration of the intervention)
Preliminary data on benefits - Functionality
Time frame: Up to three weeks (duration of the intervention)
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 9 Jan 2024.
- 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 Low Load Strength Training under Blood Flow Restriction in people with Total Knee Arthroplasty, run by HES-SO Valais-Wallis 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 12 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 9 Jan 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 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?
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?
Practicality of the study protocol - Time to teach the protocol to the personnel (time frame: Before the beginning of the procedure). The study lists 10 primary outcomes in all. 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 9 Jan 2024.