Clinical trial NCT03371901: Blood Flow Restriction Training in Patients With Weight Bearing Restrictions After Knee Surgery
Official title: Physical Therapy With Blood Flow Restriction Training to Enhance Recovery in Patients With Early Weight Bearing Restrictions After Knee Surgery: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cartilage, Articular
Tibial Meniscus Injuries
Keywords: Menisci, Tibial
Cartilage, Articular
Blood Flow Restriction Training
Resistance training
Physical Therapy Modalities
Feasibility Studies
Lead sponsor: Health Centre Nørrebro, City of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2017-12-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Thigh muscle hypertrophy assessed by thigh circumference, cm.
timeFrame: Change from baseline to the end of the 6-week rehabilitation program. Further assessments: Once a week during the 6-week rehabilitation program; 1 and 3 week(s) post-baseline, and 16 and 26 postoperative.
Secondary outcomes:
measure: Perceived exertion during exercise assessed by the Borg RPE scale (6-20)), points
timeFrame: Change from baseline to the end of the 6-week rehabilitation program. Further assessments: Once a week during the 6-week rehabilitation program; 1 and 3 week(s) post-baseline.
measure: Adherence to the BFR-LLST (Blood Flow Restriction - Low Load Strength Training) protocol assessed by patient-reporting and assessor registration, numbers.
timeFrame: Change from baseline to the end of the 6-week rehabilitation program. Further assessments: Once a week during the 6-week rehabilitation program; 1 and 3 week(s) post-baseline.
measure: Knee joint and quadriceps pain assessed by using 0-100-mm visual analog scale.
timeFrame: Change from baseline to the end of the 6-week rehabilitation program. Further assessments: Once a week during the 6-week rehabilitation program; 1 and 3 week(s) post-baseline.
measure: Knee joint swelling assessed by knee joint circumference, cm.
timeFrame: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
measure: Knee joint range of motion (ROM) assessed by goniometer, degrees
timeFrame: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
measure: Maximum isometric knee extension and flexion muscle strength at 60 degrees knee flexion assessed by a hand-held dynamometer in Nm/kg, (Newton*meter)/kg body weight
timeFrame: 26 weeks postoperative.
measure: Self-reported function and knee-related quality of life are assessed by using the Knee Injury and Osteoarthritis Outcome Score (KOOS), points
timeFrame: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
measure: Self-reported patient-specific functional change is assessed by the Patient-Specific Functional Scale (PSFS) in points
timeFrame: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
Other outcomes:
measure: Adverse events are assessed by patient-reporting and assessor registration.
timeFrame: Each visit from baseline to 26 weeks postoperative.
Locations:
city: Copenhagen
country: Denmark
facility: Section for Orthopaedic & Sports Rehabilitation (SOS-R), Health Centre Nørrebro
Study officials:
affiliation: Section for Orthopaedic & Sports Rehabilitation (SOS-R) Health Centre Nørrebro, City of Copenhagen, Denmark
name: Thomas Linding Jakobsen Jakobsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.