Anterior Cruciate Ligament InjuriesNCT04284748
Effect of Blood Flow Restriction Training on Patient With Anterior Cruciate Ligament Reconstruction
A study testing Plyometric exercise with blood flow restriction, Plyometric exercise and Routine physiotherapy program in people with Anterior Cruciate Ligament Injuries and Atrophy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of plyometric training with blood flow restriction on muscular strength, quadriceps thickness and knee joint function in patients with muscle weakness and atrophy (quadriceps muscle and hamstring muscle) after anterior cruciate ligament reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Atrophy, Muscle Weakness
- What is being tested?
- Plyometric exercise with blood flow restriction, Plyometric exercise and Routine physiotherapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2018to 15 Jun 2020
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-45 year
- Volunteering to participate in the study
- Patients who had unilateral anterior cruciate ligament surgery with hamstring tendon auto graft and completed 12 weeks of rehabilitation program
Who cannot join
- Systemic or neurological problems
- Endothelial dysfunction
- Peripheral vascular diseases and history of deep vein thrombosis
- Active infection, cancer, pregnant,
- Posterior cruciate ligament tear, medial or lateral collateral ligament tear and knee cartilage damage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Department of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: Effect of Plyometric Training With Blood Flow Restriction on Muscle Strength and Function After Anterior Cruciate Ligament Reconstruction
This study investigates the effects of plyometric training with blood flow restriction on muscular strength, quadriceps thickness and knee joint function in patients with muscle weakness and atrophy (quadriceps muscle and hamstring muscle) after anterior cruciate ligament reconstruction. Persons who completed a 12-week routine rehabilitation program after anterior cruciate ligament reconstruction will be included in the study. In the study group, plyometric exercises will be performed with blood flow restriction in the operated side for 8 weeks. In the control group, the same plyometric exercises will be performed without any application.
Read the detailed description
Anterior cruciate ligament (ACL) rupture is one of the most common sports injuries. Surgical procedure is usually performed after injury. After ACL surgery, patients experience problems such as pain, impaired knee function, and especially quadriceps muscle weakness and atrophy. Quadriceps atrophy has been shown to persist for years despite rehabilitation programs. Therefore, rehabilitation programs after ACL reconstruction play an important role in ensuring return to sports and reducing postoperative complications. In general, ACL rehabilitation can be divided into early and late periods. In the early period, while focusing on the solution of the primary problems related to the knee (pain, edema, joint movement limitation, quadriceps muscle weakness, and antalgic gait), the focus is on the patient's preparation for returning to sports activities. Running, jumping and agility training are the exercise approaches of late phase rehabilitation. These exercises include pliometric activities that trigger the stretch-shortening cycle of the lower extremity extensor muscles. Pliometric exercises after anterior cruciate ligament reconstruction may improve lower extremity muscle strength and knee function and increase the rate of return to sports, but there is not enough study in this area. Under normal conditions, 6-12 repetitive weight-lifting exercises at a density of at least 65% of a maximum repetition are recommended to increase strength in a muscle and achieve hypertrophy. However, it takes approximately 4-6 months for the ligament to mature and bear weight after surgery. For this reason, high intensity strengthening training is not used in the early period of rehabilitation to protect the graft that is recovering after surgery and the training is started from low intensity and increased gradually. Recent studies suggest that muscle hypertrophy occurs with low-intensity exercises (20-30% of a maximum repetition) with blood flow restriction, also known as KAATSU training or occlusion training. Because blood flow restriction training allows the benefits of high intensity training to be obtained at a much lower intensity. In the literature, the effectiveness of many different exercise programs after ACL reconstruction was investigated. However, no study investigating the effect of blood flow restriction plyometric exercise training on ACL rehabilitation on muscle strength and function was found. This study will be conducted to investigate the contribution of low-density plyometric training with blood flow restriction to atrophy, muscle strength, function and return to sports.
- Being tested
- Plyometric exercise with blood flow restriction, Plyometric exercise, Routine physiotherapy program
- Keywords
- anterior cruciate ligament reconstruction, atrophy, knee function
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Atrophy, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plyometric exercise with blood flow restrictionOther
Blood flow restriction training is an exercise protocol based on the method of limiting blood flow with external pressure by pneumatic tourniquet from the proximal of the muscle to be strengthened. Blood flow restriction (Occlusion) during pliometric exercises for 8 weeks, a pneumatic tourniquet (Kaatsu Master) proximal to the thigh will be applied to each patient within a safe pressure range. The pressure to be applied to the patient will be calculated with the following formula described in the literature.
Pressure = 0.5 x (systolic blood pressure) + 2 x (thigh circumference) + 5 Application will be done for a maximum of 15 minutes, then rest for 10-15 minutes and other exercises will continue.
Plyometric training with blood flow restriction. Jump in functional squat system (30+15+15+15= 75 rep) Lunge jump (30 rep) Side jump (30 rep) Box jump (15 rep) Exercises to be added after 4 weeks; Square jump (15 rep) One leg hop (15 rep)
Plyometric exerciseOther
Plyometric training Jump in functional squat system (30+15+15+15= 75 rep) Lunge jump (30 rep) Side jump (30 rep) Box jump (15 rep) Exercises to be added after 4 weeks; Square jump (15 rep) One leg hop (15 rep)
Routine physiotherapy programOther
Anterior and lateral plan exercise (3x10 rep) Open kinetic quadriceps and hamstring strengthening exercise (3x10 rep) Lunge exercises on different ground (3x10 rep) Single leg squat exercise on different ground (3x10 rep) Anterior and lateral walking exercise in a squatting position with an exercise band (40 step) Balance and proprioceptive exercises
| Study group | Role | What they receive |
|---|---|---|
| Plyometric training with blood flow restriction | Experimental | Routine physiotherapy program + Plyometric training with blood flow restriction, 3 days a week for 8 weeks Jump in functional squat system (30+15+15+15= 75 rep) Lunge jump (30 rep) Side jump (30 rep) Box jump (15 rep) Exercises to be added after 4 weeks; Square jump (15 rep) One leg hop (15 rep) Receives: Other: Plyometric exercise with blood flow restriction; Other: Routine physiotherapy program |
| Plyometric training | Active comparator | Routine physiotherapy program + Plyometric training 3 days a week for 8 weeks Jump in functional squat system (30+15+15+15= 75 rep) Lunge jump (30 rep) Side jump (30 rep) Box jump (15 rep) Exercises to be added after 4 weeks; Square jump (15 rep) One leg hop (15 rep) Receives: Other: Plyometric exercise; Other: Routine physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle thickness and rectus femoris cross-sectional ares
Thickness of rectus femoris, vastus medialis obliques, vastus lateralis muscles and cross-sectional area of rectus femoris were measured using a B-mode ultrasound device with a 9L4 linear probe before and after plyometric training.
Measured: 8 week
Hamstring and quadriceps muscle strength
Quadriceps and hamstring muscle strength (isometric, concentric and eccentric) were evaluated with an isokinetic dynamometer (IsoMed2000 D\&R GmbH, Germany) before and plyometric training.
Measured: 8 week
Secondary outcomes (8)
Vertical jump test (VJT)
The assessment leg was positioned closest to the wall. The point where the patient reached out with his hand in elbow extension was marked. Then, the patients were standing on assessment foot, one foot length away from the wall. They jumped vertically and made a mark on the wall with a marker. The distance between the patient's jump and touch point and the starting point was measured with tape. This test was performed three times for each leg, and the average of the three values was calculated. The VJT uses the limb symmetry index for VJT calculated as ([reconstructed limb-hop distance/ contralateral limb-hop distance] x 100).
Measured: 8 week
One leg hop test (OLHT)
Participants stood on one leg with toes behind a mark on the floor and performed one hop as far as possible along a straight line, landing on the same foot. The test started with the uninvolved limb followed by the involved limb. The distance in centimeter was measured. This test was performed three times for each leg, and the average of the three values was calculated. The OLHT uses the limb symmetry index for OLHT calculated as ([reconstructed limb-hop distance/ contralateral limb-hop distance] x 100).
Measured: 8 week
Single leg triple hop test (SLTHT)
Participants stood on one leg with toes behind a mark on the floor and performed triple hop as far as possible along a straight line, landing on the same foot. The test started with the uninvolved limb followed by the involved limb. The distance in centimeter was measured. This test was performed three times for each leg, and the average of the three values was calculated. The SLTHT uses the limb symmetry index for SLTHT calculated as ([reconstructed limb-hop distance/ contralateral limb-hop distance] x 100).
Measured: 8 week
Y balance test
The dynamic balances of the individuals were evaluated with the Y balance test (Modified Star Excursion Balance Test, SEBT). The test was carried out with a Y balance test kit consisting of three pipes marked with a distance in cm, with the front pipe and other pipes 135 ° and the pipes 90 ° from the back. Before the evaluation, the test was shown to the participant once and they were given a chance to try in all 3 directions. The test started with the uninvolved leg followed by the involved leg. The test was repeated 3 times in all directions and the mean was recorded. The average scores were divided by the leg length of the individual (the distance between the sipina iliaca anterior superior and the medial malleol), multiplied by 100 and recorded to normalize the reach distances in all directions.
Measured: 8 week
Knee Documentation Committee (IKDC) Questionnaire
IKDC, a valid and reliable measure for ACL injury and ACLR (ICC = 0.91), contains ten items related to knee symptoms in addition to daily and sports activities. Scores range from 0 to 100 with higher scores indicating less disability.
Measured: 8 week
Knee Injury and Osteoarthritis Outcome Questionnaire (KOOS)
The Turkish version of the KOOS scale (ICC> 0.75), a valid reliable measurement, was used to evaluate pain, functional status, daily life activity and quality of life. The scale has 5 subtitles: pain, daily life activities, sports and leisure activities, functional status and string-related quality of life. Each subtest is scored between 0 and 100. The higher score indicates better knee function.
Measured: 8 week
Tampa Kinesiophobia Scale
The Turkish validity and reliability study Tampa Kinesiophobia Scale was used to evaluate individuals' fear and avoidance of movement. The test is calculated by 17-point Likert scoring. The individual scores between 17-68 and as the score increases, the level of kinesiophobia increases.
Measured: 8 week
Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI)
The Turkish version of the ACL-RSI scale was used to evaluate individuals' return to sports rate. The scale consisting of 12 questions, scored between 0-10 according to the visual analog scale; emotions consist of performance self-confidence and risk assessment subtitles. High scores show the subjective perception of individuals about returning to sports
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start10 Dec 2018
- Primary completion15 Apr 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERDAR DEMIRCI, Hacettepe University
- Investigators
- Egemen Turhan, MD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284748
- Sponsor's protocol ID
- KA-180096
- Status last verified
- Nov 2018
- First submitted
- 7 Jan 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Plyometric Training With Blood Flow Restriction on Muscle Strength and Function After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04284748
- Acronym / sponsor ID
- KA-180096
- Keywords
- anterior cruciate ligament reconstruction, atrophy, knee function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 26 Feb 2020 (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.
This study investigates the effects of plyometric training with blood flow restriction on muscular strength, quadriceps thickness and knee joint function in patients with muscle weakness and atrophy (quadriceps muscle and hamstring muscle) after anterior cruciate ligament reconstruction. Persons who completed a 12-week routine rehabilitation program after anterior cruciate ligament reconstruction will be included in the study. In the study group, plyometric exercises will be performed with blood flow restriction in the operated side for 8 weeks. In the control group, the same plyometric exercises will be performed without any application.
Detailed description
Anterior cruciate ligament (ACL) rupture is one of the most common sports injuries. Surgical procedure is usually performed after injury. After ACL surgery, patients experience problems such as pain, impaired knee function, and especially quadriceps muscle weakness and atrophy. Quadriceps atrophy has been shown to persist for years despite rehabilitation programs. Therefore, rehabilitation programs after ACL reconstruction play an important role in ensuring return to sports and reducing postoperative complications. In general, ACL rehabilitation can be divided into early and late periods. In the early period, while focusing on the solution of the primary problems related to the knee (pain, edema, joint movement limitation, quadriceps muscle weakness, and antalgic gait), the focus is on the patient's preparation for returning to sports activities. Running, jumping and agility training are the exercise approaches of late phase rehabilitation. These exercises include pliometric activities that trigger the stretch-shortening cycle of the lower extremity extensor muscles. Pliometric exercises after anterior cruciate ligament reconstruction may improve lower extremity muscle strength and knee function and increase the rate of return to sports, but there is not enough study in this area. Under normal conditions, 6-12 repetitive weight-lifting exercises at a density of at least 65% of a maximum repetition are recommended to increase strength in a muscle and achieve hypertrophy. However, it takes approximately 4-6 months for the ligament to mature and bear weight after surgery. For this reason, high intensity strengthening training is not used in the early period of rehabilitation to protect the graft that is recovering after surgery and the training is started from low intensity and increased gradually. Recent studies suggest that muscle hypertrophy occurs with low-intensity exercises (20-30% of a maximum repetition) with blood flow restriction, also known as KAATSU training or occlusion training. Because blood flow restriction training allows the benefits of high intensity training to be obtained at a much lower intensity. In the literature, the effectiveness of many different exercise programs after ACL reconstruction was investigated. However, no study investigating the effect of blood flow restriction plyometric exercise training on ACL rehabilitation on muscle strength and function was found. This study will be conducted to investigate the contribution of low-density plyometric training with blood flow restriction to atrophy, muscle strength, function and return to sports.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plyometric training with blood flow restriction | Experimental | Other: Plyometric exercise with blood flow restriction, Other: Routine physiotherapy programRoutine physiotherapy program + Plyometric training with blood flow restriction, 3 days a week for 8 weeks Jump in functional squat system (30+15+15+15= 75 rep) Lunge jump (30 rep) Side jump (30 rep) Box jump (15 rep) Exercises to be added after 4 weeks; Square jump (15 rep) One leg hop (15 rep) |
| Plyometric training | Active comparator | Other: Plyometric exercise, Other: Routine physiotherapy programRoutine physiotherapy program + Plyometric training 3 days a week for 8 weeks Jump in functional squat system (30+15+15+15= 75 rep) Lunge jump (30 rep) Side jump (30 rep) Box jump (15 rep) Exercises to be added after 4 weeks; Square jump (15 rep) One leg hop (15 rep) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-45 year
- Volunteering to participate in the study
- Patients who had unilateral anterior cruciate ligament surgery with hamstring tendon auto graft and completed 12 weeks of rehabilitation program
Key exclusion criteria (5 listed)
- Systemic or neurological problems
- Endothelial dysfunction
- Peripheral vascular diseases and history of deep vein thrombosis
- Active infection, cancer, pregnant,
- Posterior cruciate ligament tear, medial or lateral collateral ligament tear and knee cartilage damage
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 |
|---|---|---|
| Plyometric exercise with blood flow restrictionBlood flow restriction training is an exercise protocol based on the method of limiting blood flow with external pressure by pneumatic tourniquet from the proximal of the muscle to be strengthened. Blood flow restriction (Occlusion) during pliometric exercises for 8 weeks, a pneumatic tourniquet (Kaatsu Master) proximal to the thigh will be applied to each patient within a safe pressure range. The pressure to be applied to the patient will be calculated with the following formula described in the literature. Pressure = 0.5 x (systolic blood pressure) + 2 x (thigh circumference) + 5 Application will be done for a maximum of 15 minutes, then rest for 10-15 minutes and other exercises will continue. Plyometric training with blood flow restriction. Jump in functional squat system (30+15+15+15= 75 rep) Lunge jump (30 rep) Side jump (30 rep) Box jump (15 rep) Exercises to be added after 4 weeks; Square jump (15 rep) One leg hop (15 rep) | Other | Plyometric training with blood flow restriction |
| Plyometric exercisePlyometric training Jump in functional squat system (30+15+15+15= 75 rep) Lunge jump (30 rep) Side jump (30 rep) Box jump (15 rep) Exercises to be added after 4 weeks; Square jump (15 rep) One leg hop (15 rep) | Other | Plyometric training |
| Routine physiotherapy programAnterior and lateral plan exercise (3x10 rep) Open kinetic quadriceps and hamstring strengthening exercise (3x10 rep) Lunge exercises on different ground (3x10 rep) Single leg squat exercise on different ground (3x10 rep) Anterior and lateral walking exercise in a squatting position with an exercise band (40 step) Balance and proprioceptive exercises | Other | Plyometric training, Plyometric training with blood flow restriction |
Primary outcome
Quadriceps muscle thickness and rectus femoris cross-sectional ares
Time frame: 8 week
Thickness of rectus femoris, vastus medialis obliques, vastus lateralis muscles and cross-sectional area of rectus femoris were measured using a B-mode ultrasound device with a 9L4 linear probe before and after plyometric training.
Hamstring and quadriceps muscle strength
Time frame: 8 week
Quadriceps and hamstring muscle strength (isometric, concentric and eccentric) were evaluated with an isokinetic dynamometer (IsoMed2000 D\&R GmbH, Germany) before and plyometric training.
8 secondary outcomes
Vertical jump test (VJT)
Time frame: 8 week
One leg hop test (OLHT)
Time frame: 8 week
Single leg triple hop test (SLTHT)
Time frame: 8 week
Y balance test
Time frame: 8 week
Knee Documentation Committee (IKDC) Questionnaire
Time frame: 8 week
Knee Injury and Osteoarthritis Outcome Questionnaire (KOOS)
Time frame: 8 week
Tampa Kinesiophobia Scale
Time frame: 8 week
Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI)
Time frame: 8 week
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 11 Aug 2020.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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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.
Egemen Turhan, MD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plyometric exercise with blood flow restriction, Plyometric exercise and Routine physiotherapy program in people with Anterior Cruciate Ligament Injuries and Atrophy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 11 Aug 2020. 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 Turkey (Türkiye). 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?
Quadriceps muscle thickness and rectus femoris cross-sectional ares (time frame: 8 week). The study lists 2 primary outcomes in all. 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 11 Aug 2020.