Anterior Cruciate Ligament InjuriesBUSTNCT06032247
Bilateral Versus Unilateral Strength Training After ACLR
A study testing Resistance exercise program- UL and Resistance exercise program- BL in people with Anterior Cruciate Ligament Injuries and Atrophy, Muscular, run by University of Kansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Atrophy, Muscular, Anterior Cruciate Ligament Rupture
- What is being tested?
- Resistance exercise program- UL and Resistance exercise program- BL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2023to Sep 2024
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Edwards Campus
Overland Park, Kansas, 66213
About this study
Official title: Effect of Bilateral Versus Unilateral Lower Body Resistance Training on Musculoskeletal Outcomes in Individuals With a Previous Anterior Cruciate Ligament Reconstruction
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.
- Conditions
- Anterior Cruciate Ligament Injuries, Atrophy, Muscular, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Being tested
- Resistance exercise program- UL, Resistance exercise program- BL
- Keywords
- rehabilitation, periodization, injury risk reduction, strength training
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise program- ULBehavioural
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.
Resistance exercise program- BLBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral strength training | Experimental | Resistance training three times per week for 8-weeks on one leg at a time per exercise. Receives: Behavioral: Resistance exercise program- UL |
| Bilateral strength training | Active comparator | Resistance training three times per week for 8-weeks on both legs at a time per exercise. Receives: Behavioral: Resistance exercise program- BL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9-weeks
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
Measured: 9-weeks
Secondary outcomes (6)
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
Measured: 9-weeks
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
Measured: 9-weeks
Change in jump height of both limbs
Change in jump height (cm) during countermovement jumps from PRE (baseline)
Measured: 9-weeks
Change in jump impulse of both limbs
Change in vertical jump impulse (N/kg/s) during countermovement jumps from PRE (baseline)
Measured: 9-weeks
Change in body composition
Change in body composition (body fat percentage (%)) assessed by bioelectrical impedance analysis (BIA) from PRE (baseline).
Measured: 9-weeks
Change in segmental body composition
Change in segmental (legs) fat-free mass (kg) as assessed by bioelectrical impedance analysis
Measured: 9-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start31 Aug 2023
- Primary completionMay 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: This study is withdrawn due to a lack of available recruitment within the researchers' timeframe.
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.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Cleary, MS, CPSS, CSCS, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032247
- Sponsor's protocol ID
- STUDY00150439
- Acronym
- BUST
- Status last verified
- Oct 2023
- First submitted
- 3 Sep 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Versus Unilateral Lower Body Resistance Training on Musculoskeletal Outcomes in Individuals With a Previous Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06032247
- Acronym / sponsor ID
- BUST / STUDY00150439
- Conditions
- Anterior Cruciate Ligament Injuries, Atrophy, Muscular, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Keywords
- rehabilitation, periodization, injury risk reduction, strength training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study is withdrawn due to a lack of available recruitment within the researchers' timeframe.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 11 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral strength training | Experimental | Behavioral: Resistance exercise program- ULResistance training three times per week for 8-weeks on one leg at a time per exercise. |
| Bilateral strength training | Active comparator | Behavioral: Resistance exercise program- BLResistance training three times per week for 8-weeks on both legs at a time per exercise. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Resistance exercise program- ULUnilateral 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. | Behavioural | Unilateral strength training |
| Resistance exercise program- BLBilateral 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. | Behavioural | Bilateral strength training |
Primary outcome
Change in isometric strength of the quadriceps femoris
Time frame: 9-weeks
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
Time frame: 9-weeks
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
6 secondary outcomes
Change in muscle cross-sectional area strength of the hamstrings
Time frame: 9-weeks
Change in isometric strength of the hamstrings femoris
Time frame: 9-weeks
Change in jump height of both limbs
Time frame: 9-weeks
Change in jump impulse of both limbs
Time frame: 9-weeks
Change in body composition
Time frame: 9-weeks
Change in segmental body composition
Time frame: 9-weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injuries
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
Recruiting
Quadriceps Strengthening ACL Reconstruction
ACL Tear
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise program- UL and Resistance exercise program- BL in people with Anterior Cruciate Ligament Injuries and Atrophy, Muscular, run by University of Kansas at 1 site in United States.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 27 Oct 2023. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in isometric strength of the quadriceps femoris (time frame: 9-weeks). 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 27 Oct 2023.