NCT04284748

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

August 11, 2020

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

January 7, 2020

Last Update Submit

August 9, 2020

Conditions

Keywords

anterior cruciate ligament reconstructionatrophyknee function

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    8 week

Secondary Outcomes (8)

  • Vertical jump test (VJT)

    8 week

  • One leg hop test (OLHT)

    8 week

  • Single leg triple hop test (SLTHT)

    8 week

  • Y balance test

    8 week

  • Knee Documentation Committee (IKDC) Questionnaire

    8 week

  • +3 more secondary outcomes

Study Arms (2)

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)

Other: Plyometric exercise with blood flow restrictionOther: 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)

Other: Plyometric exerciseOther: Routine physiotherapy program

Interventions

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 training with blood flow restriction

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)

Plyometric training

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 trainingPlyometric training with blood flow restriction

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Department of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesAtrophyMuscle Weakness

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Egemen Turhan, MD

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 7, 2020

First Posted

February 26, 2020

Study Start

December 10, 2018

Primary Completion

April 15, 2020

Study Completion

June 15, 2020

Last Updated

August 11, 2020

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available

Locations