Blood Flow Restriction Training in Patients With Weight Bearing Restrictions After Knee Surgery

NCT ID: NCT03371901

Last Updated: 2019-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-12
• Study Completion Date: 2019-05-14

Brief Summary

After a cartilage or meniscus repair in the knee joint, the patients experience a pronounced and persistent decrease of knee-extension strength in the operated leg, which negatively affect patients' functional performance and quality of life. A possible novel exercise modality to increase muscle strength early is a moderate blood flow restriction with low-load strength training (BFR-LLST) exercise. BFR-LLST involves application of a wrapping device to restrict the blood flow to the muscle(s) during exercise. BFR- LLST requires much less load than traditional strength training and has shown to produce positive training adaptations such as muscle hypertrophy and strength in the lower extremity in healthy subjects and patients with a knee surgery. To our knowledge, early rehabilitation with BFR-LLST has never been investigated in a population with weight bearing restrictions, such as patients recovering from cartilage or meniscus repair in the knee joint. Fear of symptom exacerbation and adverse events have precluded BFR-LLST early after knee surgery. The purpose of this study is to examine the feasibility of 9 weeks of supervised rehabilitation with BFR-LLST early after cartilage or meniscus repair in the knee joint.

Conditions

Cartilage, Articular; Tibial Meniscus Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical therapy with BFR-LLST

Group Type: EXPERIMENTAL

Physical therapy with BFR-LLST

Intervention Type: OTHER

The criteria-based rehabilitation protocol for the patients with cartilage or meniscus repair may vary according to the surgical procedures.

Patients will attend 5 individual treatments, and a 6-week supervised group-based rehabilitation program with BFR-LLST (Blood Flow Restriction - Low Load Strength Training) twice a week at the rehabilitation centre. Patient will be instructed to perform BFR-LLST 5 times a week in total (twice supervised, 3 times at home).

During each BFR-LLST session, patients are encouraged to perform 4 sets of 30 repetitions, 15 repetitions, 15 repetitions, and 15 repetitions (or to fatigue in the final set), respectively.

The exercise intervention will adhere to TIDieR (template for intervention description and replication).

Interventions

Physical therapy with BFR-LLST

The criteria-based rehabilitation protocol for the patients with cartilage or meniscus repair may vary according to the surgical procedures.

Patients will attend 5 individual treatments, and a 6-week supervised group-based rehabilitation program with BFR-LLST (Blood Flow Restriction - Low Load Strength Training) twice a week at the rehabilitation centre. Patient will be instructed to perform BFR-LLST 5 times a week in total (twice supervised, 3 times at home).

During each BFR-LLST session, patients are encouraged to perform 4 sets of 30 repetitions, 15 repetitions, 15 repetitions, and 15 repetitions (or to fatigue in the final set), respectively.

The exercise intervention will adhere to TIDieR (template for intervention description and replication).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient has a cartilage and/or meniscus repair in 1 or 2 knee(s).
• Patient is between 18 and 70 years.
• Patient is able to speak and understand Danish.
• Patient has given informed consent to participate in the study.

Exclusion Criteria

• Patient has problems that severely limits ambulatory function from unstable orthopaedic (besides cartilage repair and meniscal fixation in the knee joint), neurological, vascular or cardiac conditions.
• Patient has a history of diagnosed major psychiatric disorder.
• Patient has a history of illicit drug use; be currently abusing alcohol or currently withdrawing from alcohol abuse.
• Patient has a history of endothelial dysfunction, peripheral vascular disease, hypertension, diabetes.
• Patient has a history of heart disease and deep vein thrombosis.
• Patient is pregnant.
• Patient has cancer (current diagnosis).
• Patient has an active infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

Health Centre Nørrebro, City of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Thomas Linding Jakobsen

Research Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Linding Jakobsen Jakobsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Section for Orthopaedic & Sports Rehabilitation (SOS-R) Health Centre Nørrebro, City of Copenhagen, Denmark

Locations

Section for Orthopaedic & Sports Rehabilitation (SOS-R), Health Centre Nørrebro

Copenhagen, , Denmark

Countries

Denmark

References

Jakobsen TL, Thorborg K, Fisker J, Kallemose T, Bandholm T. Blood flow restriction added to usual care exercise in patients with early weight bearing restrictions after cartilage or meniscus repair in the knee joint: a feasibility study. J Exp Orthop. 2022 Oct 4;9(1):101. doi: 10.1186/s40634-022-00533-4.

Reference Type: DERIVED

PMID: 36192606 (View on PubMed)

Other Identifiers

SHN

Identifier Type: -

Identifier Source: org_study_id