Cartilage, ArticularNCT03371901
Blood Flow Restriction Training in Patients With Weight Bearing Restrictions After Knee Surgery
A study testing Physical therapy with BFR-LLST in people with Cartilage, Articular and Tibial Meniscus Injuries, run by Health Centre Nørrebro, City of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cartilage, Articular, Tibial Meniscus Injuries
- What is being tested?
- Physical therapy with BFR-LLST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Dec 2017to 14 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Section for Orthopaedic & Sports Rehabilitation (SOS-R), Health Centre Nørrebro
Copenhagen
About this study
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
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
- Being tested
- Physical therapy with BFR-LLST
- Keywords
- Menisci, Tibial, Cartilage, Articular, Blood Flow Restriction Training, Resistance training, Physical Therapy Modalities, Feasibility Studies
- Medical subject headings
- Tibial Meniscus Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy with BFR-LLSTOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy with BFR-LLST | Experimental | Not described Receives: Other: Physical therapy with BFR-LLST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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.
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."
Measured: 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.
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.
Measured: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
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.
Measured: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
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.
Measured: 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
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).
Measured: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
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.
Measured: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start12 Dec 2017
- Primary completion14 May 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cartilage, ArticularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Centre Nørrebro, City of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Thomas Linding Jakobsen, Health Centre Nørrebro, City of Copenhagen
- Investigators
- Thomas Linding Jakobsen Jakobsen, PhD, Principal investigator, Section for Orthopaedic & Sports Rehabilitation (SOS-R) Health Centre Nørrebro, City of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371901
- Sponsor's protocol ID
- SHN
- Status last verified
- May 2019
- First submitted
- 10 Nov 2017
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36192606
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03371901
- Acronym / sponsor ID
- SHN
- Conditions
- Cartilage, Articular, Tibial Meniscus Injuries
- Keywords
- Menisci, Tibial, Cartilage, Articular, Blood Flow Restriction Training, Resistance training, Physical Therapy Modalities, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Health Centre Nørrebro, City of CopenhagenUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 14 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical therapy with BFR-LLST | Experimental | Other: Physical therapy with BFR-LLST |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy with BFR-LLSTThe 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). | Other | Physical therapy with BFR-LLST |
Primary outcome
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.
8 secondary outcomes
Perceived exertion during exercise assessed by the Borg RPE scale (6-20)), points
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.
Adherence to the BFR-LLST (Blood Flow Restriction - Low Load Strength Training) protocol assessed by patient-reporting and assessor registration, numbers.
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.
Knee joint and quadriceps pain assessed by using 0-100-mm visual analog scale.
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.
Knee joint swelling assessed by knee joint circumference, cm.
Time frame: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
Knee joint range of motion (ROM) assessed by goniometer, degrees
Time frame: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
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
Time frame: 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
Time frame: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
Self-reported patient-specific functional change is assessed by the Patient-Specific Functional Scale (PSFS) in points
Time frame: Change from baseline to 16 weeks postoperative. Further assessment: 26 weeks postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Derived from this study: PubMed 36192606Jakobsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Linding Jakobsen Jakobsen, PhD principal investigator
Section for Orthopaedic & Sports Rehabilitation (SOS-R) Health Centre Nørrebro, City of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy with BFR-LLST in people with Cartilage, Articular and Tibial Meniscus Injuries, run by Health Centre Nørrebro, City of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.