Physical Therapy With Blood Flow Restriction Training to Enhance Recovery in Patients With Early Weight Bearing Restrictions After Knee Surgery: A Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Thigh muscle hypertrophy assessed by thigh circumference, cm.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Physical therapy with BFR-LLST
Intervention: Physical therapy with BFR-LLST (Other)
Outcomes
Primary Outcomes
Thigh muscle hypertrophy assessed by thigh circumference, cm.
Time Frame: 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.
Thigh circumference is assessed 15 cm. proximal from the basis of the patellae with a tape measure. The thigh circumference will be recorded to the nearest 0.1 cm, and assessed on both the operated and the non-operated leg. Being an exploratory feasibility study, the study is designed with a flat outcome structure with multiple evenly valued outcome measures. Thus, no primary and secondary outcome measure hierarchy exists, even though thigh muscle hypertrophy, assessed by thigh circumference, is presented as the primary outcome measure.
Secondary Outcomes
- Knee joint swelling assessed by knee joint circumference, cm.(Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.)
- Adherence to the BFR-LLST (Blood Flow Restriction - Low Load Strength Training) protocol assessed by patient-reporting and assessor registration, numbers.(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.)
- Self-reported patient-specific functional change is assessed by the Patient-Specific Functional Scale (PSFS) in points(Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.)
- Knee joint range of motion (ROM) assessed by goniometer, degrees(Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.)
- Self-reported function and knee-related quality of life are assessed by using the Knee Injury and Osteoarthritis Outcome Score (KOOS), points(Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.)
- Perceived exertion during exercise assessed by the Borg RPE scale (6-20)), points(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.)
- Knee joint and quadriceps pain assessed by using 0-100-mm visual analog scale.(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.)
- 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(26 weeks postoperative.)
Investigators
Thomas Linding Jakobsen
Research Physiotherapist
Health Centre Nørrebro, City of Copenhagen