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

Primary Purpose

Cartilage, Articular, Tibial Meniscus Injuries

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical therapy with BFR-LLST
Sponsored by
Health Centre Nørrebro, City of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cartilage, Articular focused on measuring Menisci, Tibial, Cartilage, Articular, Blood Flow Restriction Training, Resistance training, Physical Therapy Modalities, Feasibility Studies

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical therapy with BFR-LLST

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Perceived exertion during exercise assessed by the Borg RPE scale (6-20)), points
The perceived exertion during BFR-LLST (Blood Flow Restriction - Low Load Strength Training) exercise is measured by using the Borg scale ranging from 6 (no exertion at all) to 20 (maximal exertion). The patients will be asked immediately after each set of BFR-LLST.
Adherence to the BFR-LLST (Blood Flow Restriction - Low Load Strength Training) protocol assessed by patient-reporting and assessor registration, numbers.
Adherence will be assessed during patient-reporting and assessor registration during visits at the rehabilitation centre. The number of training sessions, number of sets and repetitions, and training load will be registered.
Knee joint and quadriceps pain assessed by using 0-100-mm visual analog scale.
Assessment of pain is performed before (at rest), during and after (at rest) the BFR-LLST (Blood Flow Restriction - Low Load Strength Training) at the rehabilitation centre. Additionally, maximum knee joint and quadriceps pain during the rehabilitation program are assessed. The knee and quadriceps pain are assessed using a 0-100-mm visual analog scale with end points of "no pain" and "worst pain imaginable."
Knee joint swelling assessed by knee joint circumference, cm.
Knee joint swelling of the operated leg is assessed by measuring the knee joint circumference 1 cm. proximal from the basis of the patellae with a tape measure.The knee joint circumference will be recorded to the nearest 0.1 cm.
Knee joint range of motion (ROM) assessed by goniometer, degrees
Knee joint ROM of the operated leg is assessed using a large universal goniometer with the moveable arms pointing towards the greater trochanter and the lateral malleolus, respectively. Both the passive and active ROM are recorded to the nearest 1 degree.
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
The isometric muscle strength will be assessed using a hand-held dynamometer (MicroFET2 Hoggan Health Technologies Inc, UT, USA) on both the operated and non-operated leg.
Self-reported function and knee-related quality of life are assessed by using the Knee Injury and Osteoarthritis Outcome Score (KOOS), points
The Knee injury and Osteoarthritis Outcome Score (KOOS) includes subscales of symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score).
Self-reported patient-specific functional change is assessed by the Patient-Specific Functional Scale (PSFS) in points
Patients are asked to identify 3 to 5 activities; they are having difficulty with as a result of their current problem. Each activity is scored on a 0 (unable to perform activity) to 10 (able to perform activity at same level as before injury or problem) points numeric rating scale. An average Patient-Specific Functional Scale (PSFS) score is calculated and can vary from 0 to 10, with higher scores representing higher levels of lower extremity functional status.

Full Information

First Posted
November 10, 2017
Last Updated
May 23, 2019
Sponsor
Health Centre Nørrebro, City of Copenhagen
Collaborators
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03371901
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
May 14, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Centre Nørrebro, City of Copenhagen
Collaborators
Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage, Articular, Tibial Meniscus Injuries
Keywords
Menisci, Tibial, Cartilage, Articular, Blood Flow Restriction Training, Resistance training, Physical Therapy Modalities, Feasibility Studies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical therapy with BFR-LLST
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Physical therapy with BFR-LLST
Intervention Description
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).
Primary Outcome Measure Information:
Title
Thigh muscle hypertrophy assessed by thigh circumference, cm.
Description
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.
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.
Secondary Outcome Measure Information:
Title
Perceived exertion during exercise assessed by the Borg RPE scale (6-20)), points
Description
The perceived exertion during BFR-LLST (Blood Flow Restriction - Low Load Strength Training) exercise is measured by using the Borg scale ranging from 6 (no exertion at all) to 20 (maximal exertion). The patients will be asked immediately after each set of BFR-LLST.
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.
Title
Adherence to the BFR-LLST (Blood Flow Restriction - Low Load Strength Training) protocol assessed by patient-reporting and assessor registration, numbers.
Description
Adherence will be assessed during patient-reporting and assessor registration during visits at the rehabilitation centre. The number of training sessions, number of sets and repetitions, and training load will be registered.
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.
Title
Knee joint and quadriceps pain assessed by using 0-100-mm visual analog scale.
Description
Assessment of pain is performed before (at rest), during and after (at rest) the BFR-LLST (Blood Flow Restriction - Low Load Strength Training) at the rehabilitation centre. Additionally, maximum knee joint and quadriceps pain during the rehabilitation program are assessed. The knee and quadriceps pain are assessed using a 0-100-mm visual analog scale with end points of "no pain" and "worst pain imaginable."
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.
Title
Knee joint swelling assessed by knee joint circumference, cm.
Description
Knee joint swelling of the operated leg is assessed by measuring the knee joint circumference 1 cm. proximal from the basis of the patellae with a tape measure.The knee joint circumference will be recorded to the nearest 0.1 cm.
Time Frame
Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
Title
Knee joint range of motion (ROM) assessed by goniometer, degrees
Description
Knee joint ROM of the operated leg is assessed using a large universal goniometer with the moveable arms pointing towards the greater trochanter and the lateral malleolus, respectively. Both the passive and active ROM are recorded to the nearest 1 degree.
Time Frame
Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
Title
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
Description
The isometric muscle strength will be assessed using a hand-held dynamometer (MicroFET2 Hoggan Health Technologies Inc, UT, USA) on both the operated and non-operated leg.
Time Frame
26 weeks postoperative.
Title
Self-reported function and knee-related quality of life are assessed by using the Knee Injury and Osteoarthritis Outcome Score (KOOS), points
Description
The Knee injury and Osteoarthritis Outcome Score (KOOS) includes subscales of symptoms, pain, activities of daily living, function in sport/recreation, and knee-related quality of life. A score in points for each subscale will be calculated, and it ranges from 0 (worst score) to 100 (best score).
Time Frame
Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
Title
Self-reported patient-specific functional change is assessed by the Patient-Specific Functional Scale (PSFS) in points
Description
Patients are asked to identify 3 to 5 activities; they are having difficulty with as a result of their current problem. Each activity is scored on a 0 (unable to perform activity) to 10 (able to perform activity at same level as before injury or problem) points numeric rating scale. An average Patient-Specific Functional Scale (PSFS) score is calculated and can vary from 0 to 10, with higher scores representing higher levels of lower extremity functional status.
Time Frame
Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
Other Pre-specified Outcome Measures:
Title
Adverse events are assessed by patient-reporting and assessor registration.
Description
All adverse events occurring while the patient is enrolled in the study will be documented regardless of its relation to the exercise intervention, operation or occurrences not related to the study. The number of possible adverse events are summed.
Time Frame
Each visit from baseline to 26 weeks postoperative.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Linding Jakobsen Jakobsen, PhD
Organizational Affiliation
Section for Orthopaedic & Sports Rehabilitation (SOS-R) Health Centre Nørrebro, City of Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Section for Orthopaedic & Sports Rehabilitation (SOS-R), Health Centre Nørrebro
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36192606
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.
Results Reference
derived

Learn more about this trial

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

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