Low-Load Blood Flow Restriction Training With Patients Who Underwent a Total Knee Arthroplasty: a Feasibility Trial

Total Knee Arthroplasty Clinical Trial

Official title:

Low-Load Blood Flow Restriction Training With Patients Who Underwent a Total Knee Arthroplasty: a Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05843773
• Other study ID #: 2022-01102
• Status: Completed
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: January 6, 2024

Study information

• Verified date: June 2023
• Source: HES-SO Valais-Wallis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 6, 2024
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
Switzerland	HES-SO	Sion	VS

Sponsors (3)

Lead Sponsor	Collaborator
HES-SO Valais-Wallis	Berner Fachhochschule (BFH), Leukerbad Clinic

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Before the beginning of the procedure
Primary	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	Day 1 post-inclusion
Primary	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.	Day 1 post-inclusion
Primary	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	Last day of the intervention
Primary	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	During the procedure (approximatively 3 weeks long)
Primary	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.	During the procedure (approximatively 3 weeks long)
Primary	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.	During the recruitment period (6months)
Primary	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.	During the recruitment period (6months)
Primary	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.	From date of acceptation of the project (April 2022) to the anticipated end of the project (December 2023), assessed up to 90 weeks
Primary	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).	Up to three weeks (duration of the intervention)
Secondary	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.	During the procedure (approximatively 3 weeks long)
Secondary	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.	During the procedure (approximatively 3 weeks long)
Secondary	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).	Up to three weeks (duration of the intervention)
Secondary	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).	Up to three weeks (duration of the intervention)