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Bilateral Versus Unilateral Strength Training After ACLR (BUST)

Primary Purpose

Anterior Cruciate Ligament Injuries, Atrophy, Muscular, Anterior Cruciate Ligament Rupture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance exercise program- UL
Resistance exercise program- BL
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring rehabilitation, periodization, injury risk reduction, strength training

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant has provided written and dated informed consent to participate in the study Participant is 18-35 years of age, inclusive Participant is in good health as determined by a health history questionnaire Participant has been medically cleared to return to sport after primary ACLR in the previous two years Exclusion Criteria: Participant has a history of other lower-body related injuries in the past 6-months. Participant has undergone more than one ACLR or has injured the ACL of both legs. Participant has implants, hardware, devices, or other non-removable metal material in the body that would limit the accuracy of skeletal muscle size and body composition assessments within the measurement area. Participant has a cardiovascular, metabolic, or neuromuscular disorder that contraindicates their ability to participate in an exercise program.

Sites / Locations

  • University of Kansas Edwards CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Unilateral strength training

Bilateral strength training

Arm Description

Resistance training three times per week for 8-weeks on one leg at a time per exercise.

Resistance training three times per week for 8-weeks on both legs at a time per exercise.

Outcomes

Primary Outcome Measures

Change in isometric strength of the quadriceps femoris
Change in maximal voluntary isometric contraction (MVIC) peak torque (Nm) of the quadriceps from PRE (baseline) to POST
Change in muscle cross-sectional area of the quadriceps femoris
Change in absolute muscle cross-sectional area (mCSA, cm^2) of the quadriceps femoris (vastus lateralis, rectus femoris, vastus medialis) from PRE (baseline) to POST

Secondary Outcome Measures

Change in muscle cross-sectional area strength of the hamstrings
Change in absolute muscle cross-sectional area (mCSA, cm^2) of the hamstrings (biceps femoris, semimembranous, semitendinosus) from PRE (baseline) to POST
Change in isometric strength of the hamstrings femoris
Change in maximal voluntary isometric contraction (MVIC) peak torque (Nm) of the hamstrings PRE (baseline) to POST
Change in jump height of both limbs
Change in jump height (cm) during countermovement jumps from PRE (baseline)
Change in jump impulse of both limbs
Change in vertical jump impulse (N/kg/s) during countermovement jumps from PRE (baseline)
Change in body composition
Change in body composition (body fat percentage (%)) assessed by bioelectrical impedance analysis (BIA) from PRE (baseline).
Change in segmental body composition
Change in segmental (legs) fat-free mass (kg) as assessed by bioelectrical impedance analysis

Full Information

First Posted
September 3, 2023
Last Updated
September 10, 2023
Sponsor
University of Kansas
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1. Study Identification

Unique Protocol Identification Number
NCT06032247
Brief Title
Bilateral Versus Unilateral Strength Training After ACLR
Acronym
BUST
Official Title
Effect of Bilateral Versus Unilateral Lower Body Resistance Training on Musculoskeletal Outcomes in Individuals With a Previous Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
After rehabilitation completion, there remains large deficiencies between the operative (OP) and non-operative (NOP) limbs in lower-limb outcomes (e.g., size, strength, and function) and these deficits can persist for years. Therefore, further specialized training protocols, such as the ones in the present study, are required to determine if these deficits can be lessened. The proposed project will evaluate the effect of 8-weeks of single-leg and double-leg lower-body resistance training on musculoskeletal function in individuals with a previous anterior cruciate ligament (ACL) reconstruction (ACLR) in a randomized control trial. The study will recruit 30-40 males and females between 18-35 years of age that have undergone a previous ACLR. Participants will be randomized to either the single-leg/unilateral (UL) or double-leg/bilateral (BL) training groups. Training will occur three times per week for 8-weeks. The UL group will participate in exercises such as split squats, single-leg deadlifts, or single-leg squats. The BL group will utilize exercises such as double-leg squats, conventional deadlifts, and leg presses. One week prior to (PRE) and one week after (POST) the training program, all participants will undergo a testing battery. Musculoskeletal ultrasound will measure quadriceps and hamstrings muscle cross-sectional area (mCSA), fascicle length (FL), and pennation angle (PA) of both OP and NOP limbs. Strength will be assessed through maximal voluntary isometric contractions (MVIC) for the quadriceps and hamstrings, and one-repetition maximum tests for single-leg leg extensions, leg curls, and leg press. Lower-limb function will be assessed through single-leg and double-leg jumps on a dual force plate system for jump height, impulse, rate of force development, and peak force. Data will be analyzed via separate mixed-factorial analyses of variance for the within-subjects factor of leg (OP vs. NOP) and time (PRE vs. POST) and the between-subjects factor of biological sex (male vs. female) and group (UL vs. BL). Post-hoc analyses will include lower-order ANOVAs and t-tests as pairwise comparisons when significance is detected. Significance will be established at p≤0.05. The results of this study will assist practitioners, coaches, sport scientists, and most importantly, the athletes, in the development of post-rehabilitative strength training protocols designed to reduce between-limb discrepancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Atrophy, Muscular, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Keywords
rehabilitation, periodization, injury risk reduction, strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unilateral strength training
Arm Type
Experimental
Arm Description
Resistance training three times per week for 8-weeks on one leg at a time per exercise.
Arm Title
Bilateral strength training
Arm Type
Active Comparator
Arm Description
Resistance training three times per week for 8-weeks on both legs at a time per exercise.
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise program- UL
Intervention Description
Unilateral group: Exercise sessions supervised by an exercise professional. Exercises will include single-leg squats, split squats, single-leg deadlifts, single-leg leg extensions, etc. Repetition range and volume (sets performed) will target strength and hypertrophy range with linear periodization utilized to ensure progression.
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise program- BL
Intervention Description
Bilateral group: Exercise sessions supervised by an exercise professional. Exercises will include double-leg squats, double-leg deadlifts, double-leg leg extensions, etc. Repetition range and volume (sets performed) will target strength and hypertrophy range with linear periodization utilized to ensure progression.
Primary Outcome Measure Information:
Title
Change in isometric strength of the quadriceps femoris
Description
Change in maximal voluntary isometric contraction (MVIC) peak torque (Nm) of the quadriceps from PRE (baseline) to POST
Time Frame
9-weeks
Title
Change in muscle cross-sectional area of the quadriceps femoris
Description
Change in absolute muscle cross-sectional area (mCSA, cm^2) of the quadriceps femoris (vastus lateralis, rectus femoris, vastus medialis) from PRE (baseline) to POST
Time Frame
9-weeks
Secondary Outcome Measure Information:
Title
Change in muscle cross-sectional area strength of the hamstrings
Description
Change in absolute muscle cross-sectional area (mCSA, cm^2) of the hamstrings (biceps femoris, semimembranous, semitendinosus) from PRE (baseline) to POST
Time Frame
9-weeks
Title
Change in isometric strength of the hamstrings femoris
Description
Change in maximal voluntary isometric contraction (MVIC) peak torque (Nm) of the hamstrings PRE (baseline) to POST
Time Frame
9-weeks
Title
Change in jump height of both limbs
Description
Change in jump height (cm) during countermovement jumps from PRE (baseline)
Time Frame
9-weeks
Title
Change in jump impulse of both limbs
Description
Change in vertical jump impulse (N/kg/s) during countermovement jumps from PRE (baseline)
Time Frame
9-weeks
Title
Change in body composition
Description
Change in body composition (body fat percentage (%)) assessed by bioelectrical impedance analysis (BIA) from PRE (baseline).
Time Frame
9-weeks
Title
Change in segmental body composition
Description
Change in segmental (legs) fat-free mass (kg) as assessed by bioelectrical impedance analysis
Time Frame
9-weeks
Other Pre-specified Outcome Measures:
Title
Change in dynamic strength of the quadriceps and hamstrings
Description
Change in dynamic strength (kg) of the knee extensors, knee flexors, and total thigh musculature assessed by one-repetition maximum (1-RM) testing for single-leg leg extension, single-leg leg curl, and double-leg press from PRE (baseline)
Time Frame
9-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant has provided written and dated informed consent to participate in the study Participant is 18-35 years of age, inclusive Participant is in good health as determined by a health history questionnaire Participant has been medically cleared to return to sport after primary ACLR in the previous two years Exclusion Criteria: Participant has a history of other lower-body related injuries in the past 6-months. Participant has undergone more than one ACLR or has injured the ACL of both legs. Participant has implants, hardware, devices, or other non-removable metal material in the body that would limit the accuracy of skeletal muscle size and body composition assessments within the measurement area. Participant has a cardiovascular, metabolic, or neuromuscular disorder that contraindicates their ability to participate in an exercise program.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher J Cleary, MS
Phone
781-670-6422
Email
cj.cleary@ku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley A Herda, PhD
Email
a.herda@ku.edu
Facility Information:
Facility Name
University of Kansas Edwards Campus
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher J Cleary, MS
Phone
781-670-6422
Email
cj.cleary@ku.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Bilateral Versus Unilateral Strength Training After ACLR

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