Anterior Cruciate Ligament ReconstructionTimeToMatureNCT05972876
Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction
A study testing Blood flow restriction training and Resistance training in people with Anterior Cruciate Ligament Reconstruction and Bone-Patellar Tendon-Bone Grafting, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Rationale Graft maturity is correlated with strength and biomechanical properties of the reconstructed ACL. There are concerns that heavy-load resistance training (HLRT) may have detrimental effects on ACL graft maturation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction, Bone-Patellar Tendon-Bone Grafting
- What is being tested?
- Blood flow restriction training and Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Apr 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (18-64 years) who will undergo primary BPTB reconstruction at Zuyderland Medical Center and rehabilitation at Knie-Heup centrum Plus.
Who cannot join
- venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or not willing/able to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Zuyderland Medical Center
Sittard, Limburg, 6162 BG
Jasper Most, +31(0)625159747, j.most@zuyderland.nl
About this study
Official title: MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Study
Rationale Graft maturity is correlated with strength and biomechanical properties of the reconstructed ACL. There are concerns that heavy-load resistance training (HLRT) may have detrimental effects on ACL graft maturation. Therefore, low-load blood flow restriction training (LL-BFRT) has been suggested as an alternative to HLRT. As LL-BFRT is an increasingly popular method for the rehabilitation after an ACL reconstruction, it is important to evaluate the value of this treatment.
Objectives The main objective is to evaluate the effect of LL-BFRT on MRI-based graft maturity after ACL reconstruction compared to HLRT. The secondary objectives are the effect of LL-BFRT on donor-site morbidity, range of motion, knee stability, patient reported outcome measurements, muscle strength, safe return to pre-injury level of sport and patient satisfaction. Furthermore, feasibility and safety of rehabilitation will be assessed.
Read more
Study design Randomized controlled trial . Study population Patients who will undergo primary bone-patellar tendon-bone ACL reconstruction and rehabilitation at Knie-Heup centrum Plus will be assessed for eligibility. The exclusion criteria are: venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or patients who are not willing/able to participate.
Intervention LL-BFRT includes 12 weeks of biweekly strength training and starts two weeks after surgery.
Comparison HLRT includes 12 weeks of biweekly strength training and starts two weeks after surgery.
Main study endpoints The main endpoints are MRI-based graft maturity defined as signal-to-noise quotient three and nine months after surgery.
- Being tested
- Blood flow restriction training, Resistance training
- Keywords
- Blood Flow Restriction Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction trainingBehavioural
BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure
Resistance trainingBehavioural
Resistance training will be performed without any blood flow restriction
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction training (BFRT) | Experimental | Patients in the BFRT group will perform four sets (30, 15, 15 and 15 repetitions, respectively) of unilateral leg press, seated leg extension, deadlift and squat exercises with 30s inter-set rest periods throughout a 0-90° range of motion at 30% one-repetition maximum Receives: Behavioral: Blood flow restriction training |
| Resistance training (RT) | Active comparator | Patients in the resistance training group will perform 3x10 reps (30s inter-set rest) of unilateral leg press, seated leg extension, deadlift and squat exercises exercise throughout a 0-90° range of motion with incremental increase in external-load up to 70% of patients' one-repetition maximum Receives: Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Maturity
Graft maturity will me measured as signal intensity of ACL graft using sagittal proton density-weighted images (PDWI)
Measured: 3 and 9 months after surgery
Secondary outcomes (9)
Range of motion
Range of motion will be evaluated with the use of a goniometer.
Measured: 3 and 9 months after surgery
Knee stability
With patients lying supine in 30° of flexion anterior tibial translation in mm will be measured with the use of a Rolimeter
Measured: 3 and 9 months after surgery
Anterior knee pain
anterior knee pain is measured on the Numeric Rating Scale, 0=no pain and 10=maximum pain
Measured: 3 and 9 months after surgery
Knee pain and function
Knee Osteoarthritis Outcome Score (0 to 100, 0 being the best outcome)
Measured: 3 and 9 months after surgery
Knee function
knee function (measured using the International Knee Documentation Committee, 0 to 100, 100 being the best outcome
Measured: 3 and 9 months after surgery
patient confidence
using the Anterior Cruciate Ligament Return To Sport after Injury scale, 0 to 100, 100 being the best outcome
Measured: 3 and 9 months after surgery
hamstring strength
Patients hamstring (standing leg curl) strength will be measured on the KINEO LEG PRO
Measured: 3 and 9 months after surgery
isokinetic quadriceps strength
Patients isokinetic quadriceps (seated leg extension) will be measured on the KINEO LEG PRO
Measured: 3 and 9 months after surgery
Return to pre-injury level of sport
Return to pre-injury level of sport and timing of return to sport will be evaluated by self-report
Measured: 9 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start17 Apr 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasper Most, Principal investigator, Zuyderland Medisch CentrumBaris Koc, MD, PhDc, Study director, Zuyderland Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972876
- Sponsor's protocol ID
- NL83376.096.22
- Acronym
- TimeToMature
- Status last verified
- Jan 2025
- First submitted
- 25 Jul 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared upon reasonable written request
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05972876
- Acronym / sponsor ID
- TimeToMature / NL83376.096.22
- Keywords
- Blood Flow Restriction Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Aug 2023 (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.
Rationale Graft maturity is correlated with strength and biomechanical properties of the reconstructed ACL. There are concerns that heavy-load resistance training (HLRT) may have detrimental effects on ACL graft maturation. Therefore, low-load blood flow restriction training (LL-BFRT) has been suggested as an alternative to HLRT. As LL-BFRT is an increasingly popular method for the rehabilitation after an ACL reconstruction, it is important to evaluate the value of this treatment.
Objectives The main objective is to evaluate the effect of LL-BFRT on MRI-based graft maturity after ACL reconstruction compared to HLRT. The secondary objectives are the effect of LL-BFRT on donor-site morbidity, range of motion, knee stability, patient reported outcome measurements, muscle strength, safe return to pre-injury level of sport and patient satisfaction. Furthermore, feasibility and safety of rehabilitation will be assessed.
Study design Randomized controlled trial . Study population Patients who will undergo primary bone-patellar tendon-bone ACL reconstruction and rehabilitation at Knie-Heup centrum Plus will be assessed for eligibility. The exclusion criteria are: venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or patients who are not willing/able to participate.
Intervention LL-BFRT includes 12 weeks of biweekly strength training and starts two weeks after surgery.
Comparison HLRT includes 12 weeks of biweekly strength training and starts two weeks after surgery.
Main study endpoints The main endpoints are MRI-based graft maturity defined as signal-to-noise quotient three and nine months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction training (BFRT) | Experimental | Behavioral: Blood flow restriction trainingPatients in the BFRT group will perform four sets (30, 15, 15 and 15 repetitions, respectively) of unilateral leg press, seated leg extension, deadlift and squat exercises with 30s inter-set rest periods throughout a 0-90° range of motion at 30% one-repetition maximum |
| Resistance training (RT) | Active comparator | Behavioral: Resistance trainingPatients in the resistance training group will perform 3x10 reps (30s inter-set rest) of unilateral leg press, seated leg extension, deadlift and squat exercises exercise throughout a 0-90° range of motion with incremental increase in external-load up to 70% of patients' one-repetition maximum |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (18-64 years) who will undergo primary BPTB reconstruction at Zuyderland Medical Center and rehabilitation at Knie-Heup centrum Plus.
Key exclusion criteria (1 listed)
- venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or not willing/able to participate.
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 |
|---|---|---|
| Blood flow restriction trainingBFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure | Behavioural | Blood flow restriction training (BFRT) |
| Resistance trainingResistance training will be performed without any blood flow restriction | Behavioural | Resistance training (RT) |
Primary outcome
Graft Maturity
Time frame: 3 and 9 months after surgery
Graft maturity will me measured as signal intensity of ACL graft using sagittal proton density-weighted images (PDWI)
9 secondary outcomes
Range of motion
Time frame: 3 and 9 months after surgery
Knee stability
Time frame: 3 and 9 months after surgery
Anterior knee pain
Time frame: 3 and 9 months after surgery
Knee pain and function
Time frame: 3 and 9 months after surgery
Knee function
Time frame: 3 and 9 months after surgery
patient confidence
Time frame: 3 and 9 months after surgery
hamstring strength
Time frame: 3 and 9 months after surgery
isokinetic quadriceps strength
Time frame: 3 and 9 months after surgery
Return to pre-injury level of sport
Time frame: 9 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: Undecided. Data may be shared upon reasonable written request
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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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.
Jasper Most principal investigator
Zuyderland Medisch Centrum
Baris Koc, MD, PhDc study director
Zuyderland Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction training and Resistance training in people with Anterior Cruciate Ligament Reconstruction and Bone-Patellar Tendon-Bone Grafting, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Feb 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasper Most, PhD (0031625159747, j.most@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft Maturity (time frame: 3 and 9 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025.