Low-Load Blood Flow Restriction Training With Patients Who Underwent a Total Knee Arthroplasty: a Feasibility Trial
- Conditions
- Total Knee Arthroplasty
- Interventions
- Procedure: Low Load Strength Training under Blood Flow Restriction
- Registration Number
- NCT05843773
- Lead Sponsor
- HES-SO Valais-Wallis
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Low Load Strength Training under Blood Flow Restriction Low Load Strength Training under Blood Flow Restriction Low Load Strength Training under blood flow restriction
- Primary Outcome Measures
Name Time Method Practicality of the study protocol - Human ressources needed 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 - Time to teach the protocol to the personnel 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 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 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 - Recruitment rates 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 - Time needed for the intervention 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
Acceptability of the intervention 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).
Practicality of the study protocol - Costs 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.
Practicality of the study protocol - Retention rates 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.
- Secondary Outcome Measures
Name Time Method Preliminary data on benefits - Strength During the procedure (approximatively 3 weeks long) 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.
Preliminary data on benefits - Pain During the procedure (approximatively 3 weeks long) 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.Preliminary data on benefits - Functionality Up to three weeks (duration of the intervention) 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).
Trial Locations
- Locations (1)
HES-SO
🇨ðŸ‡Sion, VS, Switzerland