Trial Outcomes & Findings for The Effect of Various Strength Training Protocols in ACL Reconstructed Participants (NCT NCT03364647)

Last Updated: 2025-01-13

Results Overview

Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

Baseline, and post-surgery (up to 5 months)

Results posted on

2025-01-13

Participant Flow

Participants were recruited from the Department of Orthopaedic Surgery \& Sports Medicine at the University of Kentucky and were scheduled to undergo surgical reconstruction by one of three orthopedic surgeons.

647 participants were assessed for eligibility. Of those, 592 participants were excluded due to not meeting inclusion criteria or declining to participate. 55 participants were randomized of which 26 received the allocated intervention (BFRT) and 26 received the SHAM intervention. 3 participants withdrew after being randomized but before receiving the intervention.

Participant milestones

Participant milestones
Measure	Arm A - Blood Flow Restriction Training Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training
Overall Study STARTED	26	26
Overall Study COMPLETED	23	25
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A - Blood Flow Restriction Training Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A - Blood Flow Restriction Training n=26 Participants Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham n=26 Participants Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training	Total n=52 Participants Total of all reporting groups
Age, Continuous	20.8 years STANDARD_DEVIATION 6.0 • n=26 Participants	21.2 years STANDARD_DEVIATION 5.3 • n=26 Participants	21.0 years STANDARD_DEVIATION 5.7 • n=52 Participants
Sex: Female, Male Female	11 Participants n=26 Participants	11 Participants n=26 Participants	22 Participants n=52 Participants
Sex: Female, Male Male	15 Participants n=26 Participants	15 Participants n=26 Participants	30 Participants n=52 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	26 participants n=26 Participants	26 participants n=26 Participants	52 participants n=52 Participants
Body Mass Index	25.3 kg/m2 STANDARD_DEVIATION 4.2 • n=26 Participants	25.7 kg/m2 STANDARD_DEVIATION 4.4 • n=26 Participants	25.4 kg/m2 STANDARD_DEVIATION 4.5 • n=52 Participants
Time since injury	20.2 Days STANDARD_DEVIATION 16.5 • n=26 Participants	24.3 Days STANDARD_DEVIATION 16.7 • n=26 Participants	22.3 Days STANDARD_DEVIATION 16.9 • n=52 Participants
Graft Type Patellar	24 Participants n=26 Participants	24 Participants n=26 Participants	48 Participants n=52 Participants
Graft Type Hamstring	1 Participants n=26 Participants	2 Participants n=26 Participants	3 Participants n=52 Participants
Graft Type Unknown (lost to follow up before surgery)	1 Participants n=26 Participants	0 Participants n=26 Participants	1 Participants n=52 Participants
Meniscal Injury Lateral	1 Participants n=26 Participants	4 Participants n=26 Participants	5 Participants n=52 Participants
Meniscal Injury Medial	7 Participants n=26 Participants	6 Participants n=26 Participants	13 Participants n=52 Participants
Meniscal Injury Both	16 Participants n=26 Participants	14 Participants n=26 Participants	30 Participants n=52 Participants
Meniscal Injury None	1 Participants n=26 Participants	2 Participants n=26 Participants	3 Participants n=52 Participants
Meniscal Injury Unknown (lost to follow up before surgery)	1 Participants n=26 Participants	0 Participants n=26 Participants	1 Participants n=52 Participants
Weight Bearing Status After Surgery Weight Bearing as Tolerated	23 Participants n=26 Participants	25 Participants n=26 Participants	48 Participants n=52 Participants
Weight Bearing Status After Surgery Non-weight Bearing	2 Participants n=26 Participants	1 Participants n=26 Participants	3 Participants n=52 Participants
Weight Bearing Status After Surgery Unknown (lost to follow up before surgery)	1 Participants n=26 Participants	0 Participants n=26 Participants	1 Participants n=52 Participants

PRIMARY outcome

Timeframe: Baseline, and post-surgery (up to 5 months)

Outcome measures

Outcome measures
Measure	Arm A - Blood Flow Restriction Training n=23 Participants Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham n=25 Participants Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training
Measure Change in Isometric Peak Torque Quadriceps Strength Baseline	2.18 Nm/Kg Standard Deviation 0.66	2.06 Nm/Kg Standard Deviation 0.65
Measure Change in Isometric Peak Torque Quadriceps Strength Post-surgery	1.96 Nm/Kg Standard Deviation 0.59	1.95 Nm/Kg Standard Deviation 0.57

PRIMARY outcome

Timeframe: Baseline and post-surgery (up to 5 months)

Population: 1 participant excluded from isokinetic strength measurement due to injury

Outcome measures

Outcome measures
Measure	Arm A - Blood Flow Restriction Training n=22 Participants Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham n=25 Participants Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training
Measure Change in Isokinetic Peak Torque Quadriceps Strength Baseline	1.03 Nm/kg Standard Deviation 0.35	1.00 Nm/kg Standard Deviation 0.41
Measure Change in Isokinetic Peak Torque Quadriceps Strength Post-surgery	1.13 Nm/kg Standard Deviation 0.33	1.09 Nm/kg Standard Deviation 0.38

PRIMARY outcome

Timeframe: Baseline and post-surgery (up to 5 months)

Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.

Outcome measures

Outcome measures
Measure	Arm A - Blood Flow Restriction Training n=23 Participants Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham n=25 Participants Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training
Measure Change in Rate of Torque Development Baseline	7.10 Nm/kg/s Standard Deviation 3.46	6.35 Nm/kg/s Standard Deviation 3.14
Measure Change in Rate of Torque Development Post-surgery	5.51 Nm/kg/s Standard Deviation 2.79	4.68 Nm/kg/s Standard Deviation 2.37

SECONDARY outcome

Timeframe: Baseline, Post-surgery (up to 5 months)

Population: Participants included in MRI analysis

MRI will be used. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.

Outcome measures

Outcome measures
Measure	Arm A - Blood Flow Restriction Training n=20 Participants Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham n=20 Participants Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training
Measure Change in Quadriceps Muscle Morphology - T1Rho Relaxation Time Baseline	0.029 milliseconds Standard Deviation 0.003	0.031 milliseconds Standard Deviation 0.004
Measure Change in Quadriceps Muscle Morphology - T1Rho Relaxation Time Post-surgery	0.030 milliseconds Standard Deviation 0.002	0.029 milliseconds Standard Deviation 0.002

SECONDARY outcome

Timeframe: Baseline, Post-surgery (up to 5 months)

Population: Participants included in MRI analysis for this measure

MRI will be used. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.

Outcome measures

Outcome measures
Measure	Arm A - Blood Flow Restriction Training n=18 Participants Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham n=19 Participants Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training
Measure Change in Quadriceps Muscle Morphology - Physiological Cross-sectional Area (PCSA) Baseline	6238.7 mm2 Standard Deviation 1783.0	6290.9 mm2 Standard Deviation 1942.5
Measure Change in Quadriceps Muscle Morphology - Physiological Cross-sectional Area (PCSA) Post-surgery	6626.0 mm2 Standard Deviation 2484.6	6386.6 mm2 Standard Deviation 1862.2

SECONDARY outcome

Timeframe: Baseline and post-surgery (up to 5 months)

3D Motion Capture will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.

Outcome measures

Outcome measures
Measure	Arm A - Blood Flow Restriction Training n=23 Participants Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham n=25 Participants Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training
Measure Change in Knee Biomechanics - Peak Knee Flexion Baseline	21.51 degrees Standard Deviation 4.66	22.50 degrees Standard Deviation 4.42
Measure Change in Knee Biomechanics - Peak Knee Flexion Post-surgery	16.87 degrees Standard Deviation 8.05	16.63 degrees Standard Deviation 4.76

SECONDARY outcome

Timeframe: Baseline and post-surgery (up to 5 months)

Outcome measures

Outcome measures
Measure	Arm A - Blood Flow Restriction Training n=23 Participants Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham n=25 Participants Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training
Measure Change in Knee Biomechanics - Knee Extensor Moment (KEM) Baseline	0.16 (Nm/(kg*m) Standard Deviation 0.11	0.19 (Nm/(kg*m) Standard Deviation 0.12
Measure Change in Knee Biomechanics - Knee Extensor Moment (KEM) Post-surgery	0.16 (Nm/(kg*m) Standard Deviation 0.16	0.13 (Nm/(kg*m) Standard Deviation 0.14

OTHER_PRE_SPECIFIED outcome

Timeframe: Before surgery, 4 months after surgery

Muscle biopsy, which may include immunohistochemistry, histochemistry, protein expression, gene expression, or single fiber morphology may be measured. Analyses may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.

Outcome measures

Outcome data not reported

Adverse Events

Arm A - Blood Flow Restriction Training

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B - Standard of Care Plus Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A - Blood Flow Restriction Training n=23 participants at risk Group will use blood flow restriction training and standard of care Arm A - blood flow restriction training: Group receive standard of care plus blood flow restriction training	Arm B - Standard of Care Plus Sham n=25 participants at risk Group will receive standard of care plus a sham version of blood flow restriction training Arm B - standard of care: Group will receive standard of care plus a sham version of blood flow restriction training
Musculoskeletal and connective tissue disorders Patellar Fracture	4.3% 1/23 • Number of events 1 • 5 months	0.00% 0/25 • 5 months

Other adverse events

Adverse event data not reported

Additional Information

Brian Noehren

University of Kentucky

Phone: 859-323-1100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place