Clinical trial NCT05843773: Low-Load Blood Flow Restriction Training With Patients Who Underwent a Total Knee Arthroplasty: a Feasibility Trial
Official title: Low-Load Blood Flow Restriction Training With Patients Who Underwent a Total Knee Arthroplasty: a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: strength training
blood flow restriction
total knee arthroplasty
Lead sponsor: HES-SO Valais-Wallis
Sponsor class: OTHER
Collaborators: name: Leukerbad Clinic
name: Berner Fachhochschule (BFH)
First posted: 2023-05-06
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Practicality of the study protocol - Time to teach the protocol to the personnel
timeFrame: Before the beginning of the procedure
measure: Practicality of the study protocol - Time needed for the pre-tests
timeFrame: Day 1 post-inclusion
measure: Practicality of the study protocol - Time needed for the post-tests
timeFrame: Day 1 post-inclusion
measure: Practicality of the study protocol - Time needed for the post-tests
timeFrame: Last day of the intervention
measure: Practicality of the study protocol - Time needed for the intervention
timeFrame: During the procedure (approximatively 3 weeks long)
measure: Practicality of the study protocol - Human ressources needed
timeFrame: During the procedure (approximatively 3 weeks long)
measure: Practicality of the study protocol - Recruitment rates
timeFrame: During the recruitment period (6months)
measure: Practicality of the study protocol - Retention rates
timeFrame: During the recruitment period (6months)
measure: Practicality of the study protocol - Costs
timeFrame: From date of acceptation of the project (April 2022) to the anticipated end of the project (December 2023), assessed up to 90 weeks
measure: Acceptability of the intervention
timeFrame: Up to three weeks (duration of the intervention)
Secondary outcomes:
measure: Preliminary data on benefits - Strength
timeFrame: During the procedure (approximatively 3 weeks long)
measure: Preliminary data on benefits - Pain
timeFrame: During the procedure (approximatively 3 weeks long)
measure: Preliminary data on benefits - Functionality
timeFrame: Up to three weeks (duration of the intervention)
measure: Preliminary data on benefits - Functionality
timeFrame: Up to three weeks (duration of the intervention)
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: HES-SO
state: VS
Study officials:
References: