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

NCT05843773 | Completed DMC

• 1 other identifier: 2022-01102
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Keywords

strength training; blood flow restriction; total knee arthroplasty

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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)

• 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)

• 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)

• 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)

• 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

• 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 Outcomes (4)

• Preliminary data on benefits - Strength

  During the procedure (approximatively 3 weeks long)

• Preliminary data on benefits - Pain

  During the procedure (approximatively 3 weeks long)

• Preliminary data on benefits - Functionality

  Up to three weeks (duration of the intervention)

• Preliminary data on benefits - Functionality

  Up to three weeks (duration of the intervention)

Study Arms (1)

Low Load Strength Training under Blood Flow Restriction

EXPERIMENTAL

Low Load Strength Training under blood flow restriction

Procedure: Low Load Strength Training under Blood Flow Restriction

Interventions

Low Load Strength Training under Blood Flow Restriction PROCEDURE

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.

Low Load Strength Training under Blood Flow Restriction

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to participate fully in physiotherapy
• Ability to consent for study participation
• Age between 50 and 80 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• HES-SO Valais-Wallis: lead
• Leukerbad Clinic: collaborator
• Berner Fachhochschule (BFH): collaborator

Study Sites (1)

HES-SO

Sion, Valais, 1950, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: May 6, 2023
• Study Start: May 15, 2023
• Primary Completion: October 15, 2023
• Study Completion: January 6, 2024
• Last Updated: January 9, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)