An interventional study of Low Load Strength Training under Blood Flow Restriction in Total Knee Arthroplasty, sponsored by HES-SO Valais-Wallis. Completed at 1 site in Switzerland. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by HES-SO Valais-Wallis · Not applicable, Interventional, and Treatment
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.
HES-SO Valais-Wallis is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low Load Strength Training under blood flow restriction
Procedure: Low Load Strength Training under Blood Flow Restriction
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.
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
Time frame: 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
Time frame: 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.
Time frame: 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 frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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).
Time frame: Up to three weeks (duration of the intervention)
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Up to three weeks (duration of the intervention)
Plan to share: No
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HES-SO Valais-Wallis