Trial Outcomes & Findings for Blood Flow Restriction Training (BFR) in an Adolescent Population (NCT NCT04285879)
NCT ID: NCT04285879
Last Updated: 2024-07-17
Results Overview
Isometric strength testing to measure peak torque quadriceps strength (unit: nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
3 month and return to sport post-operative strength (6-8 months post-op)
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
BFR Exercise Group
In addition to the standard ACL protocol, patients in this study will utilize the Owen Recovery Science exercise protocol for BFR \[18\]. The following guidelines will be followed concerning exercise progression, occlusion pressure and difficulties with volume achievement.
A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study.
Blood Flow Restriction using Delfi Personalized Tourniquet System: The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol
|
Non-BFR Exercise Group
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine. Per our IRB protocol, should we be unable to obtain prospective controls a review of prior patients from previous patients matched for age, sex and Surgical procedure to provide a retrospective cohort.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
14
|
|
Overall Study
COMPLETED
|
16
|
6
|
|
Overall Study
NOT COMPLETED
|
17
|
8
|
Reasons for withdrawal
| Measure |
BFR Exercise Group
In addition to the standard ACL protocol, patients in this study will utilize the Owen Recovery Science exercise protocol for BFR \[18\]. The following guidelines will be followed concerning exercise progression, occlusion pressure and difficulties with volume achievement.
A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study.
Blood Flow Restriction using Delfi Personalized Tourniquet System: The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol
|
Non-BFR Exercise Group
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine. Per our IRB protocol, should we be unable to obtain prospective controls a review of prior patients from previous patients matched for age, sex and Surgical procedure to provide a retrospective cohort.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
8
|
|
Overall Study
medical/surgical exclusion
|
16
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BFR Exercise Group
n=33 Participants
In addition to the standard ACL protocol, patients in this study will utilize the Owen Recovery Science exercise protocol for BFR \[18\]. The following guidelines will be followed concerning exercise progression, occlusion pressure and difficulties with volume achievement.
A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study.
Blood Flow Restriction using Delfi Personalized Tourniquet System: The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol
|
Non-BFR Exercise Group
n=14 Participants
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.46 years
n=33 Participants
|
15.33 years
n=14 Participants
|
15.43 years
n=47 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=33 Participants
|
9 Participants
n=14 Participants
|
29 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=33 Participants
|
5 Participants
n=14 Participants
|
18 Participants
n=47 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height
|
65.64 inches
n=33 Participants
|
65.66 inches
n=14 Participants
|
65.65 inches
n=47 Participants
|
|
weight
|
146 lbs
n=33 Participants
|
165 lbs
n=14 Participants
|
151 lbs
n=47 Participants
|
PRIMARY outcome
Timeframe: 3 month and return to sport post-operative strength (6-8 months post-op)Population: We enrolled 47 patients in our study. Due to exclusion criteria, patients lost to follow up and COVID-19 pandemic we were unable to fully analyze all consented patients in both groups.
Isometric strength testing to measure peak torque quadriceps strength (unit: nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.
Outcome measures
| Measure |
BFR Exercise Group
n=33 Participants
In addition to the standard ACL protocol, patients in this study will utilize the Owen Recovery Science exercise protocol for BFR \[18\]. The following guidelines will be followed concerning exercise progression, occlusion pressure and difficulties with volume achievement.
A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study.
Blood Flow Restriction using Delfi Personalized Tourniquet System: The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol
|
Non-BFR Exercise Group
n=14 Participants
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine.
due to limitations in our prospective control, we use an aged match retrospective cohort of 16 patients for analysis.
|
|---|---|---|
|
Isometric Quad Strength Peak Torque
return to sport isometric (between approximately 6-8 months post-op)
|
2.45 Nm/kg
Standard Deviation 0.64
|
2.1 Nm/kg
Standard Deviation 0.6
|
|
Isometric Quad Strength Peak Torque
3 month isometric
|
1.83 Nm/kg
Standard Deviation .35
|
1.31 Nm/kg
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: 3 month and return to sport isometric quad strength limb symmetryPopulation: We enrolled 47 patients in our study. Due to exclusion criteria, patients lost to follow up and COVID-19 pandemic we were unable to use all patients that were consented for analysis.
Quadriceps limb symmetry index is calculated by taking the values from outcome 1. \[ ( peak torque quadriceps involved limb (nm-kg)/ peak torque quadriceps uninvolved limb (nm-kg))\*100\] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry. Should involve limb demonstrate greater strength then uninvolved limb symmetry scores would be greater then 100%
Outcome measures
| Measure |
BFR Exercise Group
n=33 Participants
In addition to the standard ACL protocol, patients in this study will utilize the Owen Recovery Science exercise protocol for BFR \[18\]. The following guidelines will be followed concerning exercise progression, occlusion pressure and difficulties with volume achievement.
A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study.
Blood Flow Restriction using Delfi Personalized Tourniquet System: The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol
|
Non-BFR Exercise Group
n=14 Participants
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine.
due to limitations in our prospective control, we use an aged match retrospective cohort of 16 patients for analysis.
|
|---|---|---|
|
Isometric Quad Strength Limb Symmetry Index
3 month post-op
|
68.02 percent
Standard Deviation 13.94
|
60.72 percent
Standard Deviation 17.54
|
|
Isometric Quad Strength Limb Symmetry Index
Return to sport (@ 6-8 months post-op)
|
89.53 percent
Standard Deviation 27.74
|
80.97 percent
Standard Deviation 10.69
|
PRIMARY outcome
Timeframe: at 3 months post-op and return to sport (between approximately 6-8 months post-op)Population: We enrolled 47 patients in our study. Due to exclusion criteria, patients lost to follow up and COVID-19 pandemic we were unable to use all data for consented subjects in both groups.
Isometric strength testing to measure peak torque hamstring strength (unit:nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.
Outcome measures
| Measure |
BFR Exercise Group
n=33 Participants
In addition to the standard ACL protocol, patients in this study will utilize the Owen Recovery Science exercise protocol for BFR \[18\]. The following guidelines will be followed concerning exercise progression, occlusion pressure and difficulties with volume achievement.
A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study.
Blood Flow Restriction using Delfi Personalized Tourniquet System: The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol
|
Non-BFR Exercise Group
n=14 Participants
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine.
due to limitations in our prospective control, we use an aged match retrospective cohort of 16 patients for analysis.
|
|---|---|---|
|
Isometric Hamstring Strength Peak Torque
3 months post-op
|
1.20 nm/kg
Standard Deviation 0.51
|
1.61 nm/kg
Standard Deviation 0.36
|
|
Isometric Hamstring Strength Peak Torque
return to sport (between approximately 6-8 months post-op)
|
1.53 nm/kg
Standard Deviation 0.30
|
1.3 nm/kg
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: 3 months post op and return to sport (between approximately 6-8 months post-op)Population: We enrolled 47 patients in our study. Due to exclusion criteria, patients lost to follow up and COVID-19 pandemic we were unable to use data for all consented patients for both groups.
Hamstring limb symmetry index is calculated by taking the values from outcome 3 \[ ( peak torque hamstring involved limb (nm-kg) / peak torque hamstring uninvolved limb (nm-kg))\*100\] as reported by isokinetic dynamometer. This value is expressed as a percentage.100% would equal symmetry. For patients that demonstrate a stronger involved limb then uninvolved limb symmetry will be reported as greater then 100%
Outcome measures
| Measure |
BFR Exercise Group
n=33 Participants
In addition to the standard ACL protocol, patients in this study will utilize the Owen Recovery Science exercise protocol for BFR \[18\]. The following guidelines will be followed concerning exercise progression, occlusion pressure and difficulties with volume achievement.
A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study.
Blood Flow Restriction using Delfi Personalized Tourniquet System: The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol
|
Non-BFR Exercise Group
n=14 Participants
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine.
due to limitations in our prospective control, we use an aged match retrospective cohort of 16 patients for analysis.
|
|---|---|---|
|
Isometric Hamstring Strength Limb Symmetry Index
return to sport (between approximately 6-8 months post-op)
|
96.74 percent
Standard Deviation 11.68
|
85.61 percent
Standard Deviation 16.21
|
|
Isometric Hamstring Strength Limb Symmetry Index
3 months post-op
|
108.32 percent
Standard Deviation 21.41
|
80.3 percent
Standard Deviation 14.71
|
SECONDARY outcome
Timeframe: at 3 months post-op and return to sport (between approximately 6-8 months post-op)Population: We enrolled 47 patients in our study. Due to exclusion criteria, patients lost to follow up and COVID-19 pandemic we were unable to use all data for all consented patients in both groups
Patient Reported Outcome Measure- Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Outcome measures
| Measure |
BFR Exercise Group
n=33 Participants
In addition to the standard ACL protocol, patients in this study will utilize the Owen Recovery Science exercise protocol for BFR \[18\]. The following guidelines will be followed concerning exercise progression, occlusion pressure and difficulties with volume achievement.
A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study.
Blood Flow Restriction using Delfi Personalized Tourniquet System: The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol
|
Non-BFR Exercise Group
n=14 Participants
As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine.
due to limitations in our prospective control, we use an aged match retrospective cohort of 16 patients for analysis.
|
|---|---|---|
|
Pedi-IKDC (International Knee Documentation Committee)
3 months
|
68.91 units on a scale
Standard Deviation 9.68
|
71.82 units on a scale
Standard Deviation 16.78
|
|
Pedi-IKDC (International Knee Documentation Committee)
return to sport (between approximately 6-8 months post-op)
|
89.42 units on a scale
Standard Deviation 7.94
|
80.90 units on a scale
Standard Deviation 8.04
|
Adverse Events
BFR Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-BFR Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place