- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04284748
Effect of Blood Flow Restriction Training on Patient With Anterior Cruciate Ligament Reconstruction
Effect of Plyometric Training With Blood Flow Restriction on Muscle Strength and Function After Anterior Cruciate Ligament Reconstruction
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey, 06100
- Hacettepe University, Department of Physical Therapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Plyometric training with blood flow restriction
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)
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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)
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
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Active Comparator: Plyometric training
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)
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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
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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quadriceps muscle thickness and rectus femoris cross-sectional ares
Time Frame: 8 week
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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.
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8 week
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Hamstring and quadriceps muscle strength
Time Frame: 8 week
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Quadriceps and hamstring muscle strength (isometric, concentric and eccentric) were evaluated with an isokinetic dynamometer (IsoMed2000 D&R GmbH, Germany) before and plyometric training.
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8 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vertical jump test (VJT)
Time Frame: 8 week
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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).
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8 week
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One leg hop test (OLHT)
Time Frame: 8 week
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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).
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8 week
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Single leg triple hop test (SLTHT)
Time Frame: 8 week
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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).
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8 week
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Y balance test
Time Frame: 8 week
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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.
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8 week
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Knee Documentation Committee (IKDC) Questionnaire
Time Frame: 8 week
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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.
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8 week
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Knee Injury and Osteoarthritis Outcome Questionnaire (KOOS)
Time Frame: 8 week
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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.
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8 week
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Tampa Kinesiophobia Scale
Time Frame: 8 week
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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.
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8 week
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Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI)
Time Frame: 8 week
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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
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8 week
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Egemen Turhan, MD, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-180096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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