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

NCT ID: NCT05843773

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2024-01-06

Brief Summary

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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

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Load Strength Training under Blood Flow Restriction

Low Load Strength Training under blood flow restriction

Group Type EXPERIMENTAL

Low Load Strength Training under Blood Flow Restriction

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leukerbad Clinic

UNKNOWN

Sponsor Role collaborator

Berner Fachhochschule (BFH)

UNKNOWN

Sponsor Role collaborator

HES-SO Valais-Wallis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HES-SO

Sion, Valais, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2022-01102

Identifier Type: -

Identifier Source: org_study_id

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