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

NCT03371901 | Completed DMC

• 1 other identifier: SHN
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Menisci, Tibial; Cartilage, Articular; Blood Flow Restriction Training; Resistance training; Physical Therapy Modalities; Feasibility Studies

Outcome Measures

Primary Outcomes (1)

• Thigh muscle hypertrophy assessed by thigh circumference, cm.

  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.

  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 (8)

• 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.

• 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.

• 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.

• Knee joint swelling assessed by knee joint circumference, cm.

  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.

Other Outcomes (1)

• Adverse events are assessed by patient-reporting and assessor registration.

  Each visit from baseline to 26 weeks postoperative.

Study Arms (1)

Physical therapy with BFR-LLST

EXPERIMENTAL

Other: Physical therapy with BFR-LLST

Interventions

Physical therapy with BFR-LLST 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).

Physical therapy with BFR-LLST

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Health Centre Nørrebro, City of Copenhagen: lead
• Hvidovre University Hospital: collaborator

Study Sites (1)

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

Copenhagen, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36192606 DERIVED

MeSH Terms

Conditions

Tibial Meniscus Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Thomas Linding Jakobsen Jakobsen, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiotherapist

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: December 13, 2017
• Study Start: December 12, 2017
• Primary Completion: May 14, 2019
• Study Completion: May 14, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

DK (1)