Trial Outcomes & Findings for Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction (NCT NCT04484961)
NCT ID: NCT04484961
Last Updated: 2024-11-25
Results Overview
LE lean muscle mass was measured in kilograms using DEXA (iDXA, GE®)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery
Results posted on
2024-11-25
Participant Flow
Houston hospital and clinic locations
Examples of why a patient might be enrolled and then not assigned to a study arm would be: * new injury * deciding on a different PT location * time constraints
Participant milestones
| Measure |
Control - Routine Rehab
Participants in this group received standard ACL rehab with no blood flow restriction therapy.
|
Experimental - BFR
Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.
Blood flow restriction (BFR): The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
Control - Routine Rehab
Participants in this group received standard ACL rehab with no blood flow restriction therapy.
|
Experimental - BFR
Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.
Blood flow restriction (BFR): The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control - Routine Rehab
n=24 Participants
Participants in this group received standard ACL rehab with no blood flow restriction therapy.
|
Experimental - BFR
n=26 Participants
Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.
Blood flow restriction (BFR): The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=24 Participants
|
26 Participants
n=26 Participants
|
50 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=24 Participants
|
8 Participants
n=26 Participants
|
19 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=24 Participants
|
18 Participants
n=26 Participants
|
31 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgeryLE lean muscle mass was measured in kilograms using DEXA (iDXA, GE®)
Outcome measures
| Measure |
Control
n=15 Participants
Standard PT, No BFR Injured Limb
|
Experimental - BFR
n=17 Participants
Standard PT, BFR Injured Limb
|
|---|---|---|
|
Determine if BFR Changes Loss of LE Lean Muscle Mass
Pre-Surgery Whole Limb Lean Mass
|
8.97 kg
Standard Deviation 0.21
|
8.97 kg
Standard Deviation 0.20
|
|
Determine if BFR Changes Loss of LE Lean Muscle Mass
6 week post surgery Whole Limb Lean Mass
|
8.37 kg
Standard Deviation 0.21
|
8.93 kg
Standard Deviation 0.20
|
|
Determine if BFR Changes Loss of LE Lean Muscle Mass
12 Week Post Surgery Whole Limb Lean Mass
|
8.58 kg
Standard Deviation 0.21
|
9.04 kg
Standard Deviation 0.20
|
|
Determine if BFR Changes Loss of LE Lean Muscle Mass
Pre-Surgery Thigh Lean Mass
|
3.18 kg
Standard Deviation 0.07
|
3.18 kg
Standard Deviation 0.06
|
|
Determine if BFR Changes Loss of LE Lean Muscle Mass
6 week post surgery Thigh Lean Mass
|
2.91 kg
Standard Deviation 0.07
|
3.10 kg
Standard Deviation 0.06
|
|
Determine if BFR Changes Loss of LE Lean Muscle Mass
12 week post surgery Thigh Lean Mass
|
3.04 kg
Standard Deviation 0.07
|
3.18 kg
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgeryBone mass was measured in grams using DEXA (iDXA, GE®)
Outcome measures
| Measure |
Control
n=15 Participants
Standard PT, No BFR Injured Limb
|
Experimental - BFR
n=17 Participants
Standard PT, BFR Injured Limb
|
|---|---|---|
|
Determine if BFR Changes Loss of Bone Mass
Whole Limb Bone Mass at Pre-surgery
|
567.9 g
Standard Deviation 6.4
|
568.2 g
Standard Deviation 6.1
|
|
Determine if BFR Changes Loss of Bone Mass
Whole Limb Bone Mass at 6 weeks post-operation
|
555 g
Standard Deviation 6.4
|
567.2 g
Standard Deviation 6.1
|
|
Determine if BFR Changes Loss of Bone Mass
Whole Limb Bone Mass at 12 weeks post-operation
|
550.9 g
Standard Deviation 6.4
|
565.4 g
Standard Deviation 6.1
|
|
Determine if BFR Changes Loss of Bone Mass
Femur Bone Mass at Pre-surgery
|
156.2 g
Standard Deviation 2.5
|
156.4 g
Standard Deviation 2.3
|
|
Determine if BFR Changes Loss of Bone Mass
Femur Bone Mass at 6 weeks post surgery
|
151.2 g
Standard Deviation 2.5
|
154.3 g
Standard Deviation 2.3
|
|
Determine if BFR Changes Loss of Bone Mass
Femur Bone Mass at 12 weeks post surgery
|
148.9 g
Standard Deviation 1.8
|
153 g
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgeryBone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)
Outcome measures
| Measure |
Control
n=15 Participants
Standard PT, No BFR Injured Limb
|
Experimental - BFR
n=17 Participants
Standard PT, BFR Injured Limb
|
|---|---|---|
|
Determine if BFR Changes Loss of Bone Mineral Density
Distal Femur Bone Mineral density at pre-surgery
|
1.2 g/cm^2
Standard Deviation 0.02
|
1.2 g/cm^2
Standard Deviation 0.02
|
|
Determine if BFR Changes Loss of Bone Mineral Density
Distal Femur Bone Mineral density at 6 weeks post-operation
|
1.1 g/cm^2
Standard Deviation 0.02
|
1.2 g/cm^2
Standard Deviation 0.02
|
|
Determine if BFR Changes Loss of Bone Mineral Density
Distal Femur Bone Mineral density at 12 weeks post-operation
|
1.1 g/cm^2
Standard Deviation 0.02
|
1.1 g/cm^2
Standard Deviation 0.02
|
|
Determine if BFR Changes Loss of Bone Mineral Density
Proximal Tibia Bone Mineral density at pre-surgery
|
1.47 g/cm^2
Standard Deviation 0.02
|
1.47 g/cm^2
Standard Deviation 0.04
|
|
Determine if BFR Changes Loss of Bone Mineral Density
Proximal Tibia Bone Mineral density at 6 weeks post surgery
|
1.40 g/cm^2
Standard Deviation 0.02
|
1.44 g/cm^2
Standard Deviation 0.04
|
|
Determine if BFR Changes Loss of Bone Mineral Density
Proximal Tibia Bone Mineral density at 12 weeks post surgery
|
1.35 g/cm^2
Standard Deviation 0.03
|
1.44 g/cm^2
Standard Deviation 0.03
|
|
Determine if BFR Changes Loss of Bone Mineral Density
Proximal Fibia Bone Mineral Density at pre-surgery
|
0.46 g/cm^2
Standard Deviation 0.02
|
0.46 g/cm^2
Standard Deviation 0.02
|
|
Determine if BFR Changes Loss of Bone Mineral Density
Proximal Fibia Bone Mineral Density at 6 weeks post-surgery
|
0.40 g/cm^2
Standard Deviation 0.02
|
0.42 g/cm^2
Standard Deviation 0.02
|
|
Determine if BFR Changes Loss of Bone Mineral Density
Proximal Fibia Bone Mineral Density at 12 weeks post surgery
|
0.38 g/cm^2
Standard Deviation 0.02
|
0.43 g/cm^2
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Week 8 and Week 12 post-surgerySingle leg (SL) squat (best of 3 attempts)
Outcome measures
| Measure |
Control
n=15 Participants
Standard PT, No BFR Injured Limb
|
Experimental - BFR
n=17 Participants
Standard PT, BFR Injured Limb
|
|---|---|---|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL Squat Week 12
|
40.9 cm
Standard Deviation 5.4
|
43.0 cm
Standard Deviation 5.5
|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL Squat Week 8
|
34.3 cm
Standard Deviation 6.3
|
33.4 cm
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 8 weeks post surgery, 12 weeks post surgerySL eccentric step down (reps to fatigue or inadequate technique)
Outcome measures
| Measure |
Control
n=15 Participants
Standard PT, No BFR Injured Limb
|
Experimental - BFR
n=17 Participants
Standard PT, BFR Injured Limb
|
|---|---|---|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL eccentric step down at 8 weeks post surgery
|
44.3 reps
Standard Deviation 14.7
|
45.1 reps
Standard Deviation 13.9
|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL eccentric step down at 12 weeks post surgery
|
61.0 reps
Standard Deviation 18.6
|
62.7 reps
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: 8 weeks post surgery, 12 weeks post surgeryY-balance anterior (best of 3 attempts)
Outcome measures
| Measure |
Control
n=15 Participants
Standard PT, No BFR Injured Limb
|
Experimental - BFR
n=17 Participants
Standard PT, BFR Injured Limb
|
|---|---|---|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Y-balance anterior (best of 3 attempts) at 8 weeks post surgery
|
48.7 cm
Standard Deviation 14.3
|
50.0 cm
Standard Deviation 2.2
|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Y-balance anterior (best of 3 attempts) at 12 weeks post surgery
|
55.9 cm
Standard Deviation 18.6
|
62.7 cm
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: 8 weeks post surgery, 12 weeks post surgeryY-balance posteromedial (best of 3 attempts)
Outcome measures
| Measure |
Control
n=15 Participants
Standard PT, No BFR Injured Limb
|
Experimental - BFR
n=17 Participants
Standard PT, BFR Injured Limb
|
|---|---|---|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Y-balance posteromedial (best of 3 attempts) at 8 weeks post surgery
|
93.3 cm
Standard Deviation 8.6
|
93.9 cm
Standard Deviation 7.4
|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Y-balance posteromedial (best of 3 attempts) at 12 weeks post surgery
|
104.4 cm
Standard Deviation 9.2
|
100.0 cm
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 8 weeks post surgery, 12 weeks post surgeryY-balance posterolateral (best of 3 attempts)
Outcome measures
| Measure |
Control
n=15 Participants
Standard PT, No BFR Injured Limb
|
Experimental - BFR
n=17 Participants
Standard PT, BFR Injured Limb
|
|---|---|---|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Y-balance posterolateral (best of 3 attempts) at 8 weeks post surgery
|
90.3 cm
Standard Deviation 10.3
|
91.9 cm
Standard Deviation 4.6
|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
Y-balance posterolateral (best of 3 attempts) at 12 weeks post surgery
|
104.5 cm
Standard Deviation 9.2
|
99.7 cm
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 8 weeks post surgery, 12 weeks post surgerySL leg press (1RM)
Outcome measures
| Measure |
Control
n=15 Participants
Standard PT, No BFR Injured Limb
|
Experimental - BFR
n=17 Participants
Standard PT, BFR Injured Limb
|
|---|---|---|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL leg press (1RM) at 8 weeks post surgery
|
58.6 kg
Standard Deviation 8.0
|
59.3 kg
Standard Deviation 10.0
|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL leg press (1RM) at 12 weeks post surgery
|
76.5 kg
Standard Deviation 9.0
|
72.7 kg
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: 8 weeks post surgery, 12 weeks post surgerySL hamstring curl (1RM)
Outcome measures
| Measure |
Control
n=15 Participants
Standard PT, No BFR Injured Limb
|
Experimental - BFR
n=17 Participants
Standard PT, BFR Injured Limb
|
|---|---|---|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL hamstring curl (1RM) at 8 weeks post surgery
|
29.9 kg
Standard Deviation 5.1
|
28.2 kg
Standard Deviation 4.2
|
|
Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing
SL hamstring curl (1RM) at 12 weeks post surgery
|
38.5 kg
Standard Deviation 4.5
|
37.7 kg
Standard Deviation 4.9
|
Adverse Events
Treatment Group: BFR
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control - Routine Rehab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group: BFR
n=26 participants at risk
BFR Treatment Group
|
Control - Routine Rehab
n=24 participants at risk
Control Group
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Mild Muscle Strain
|
3.8%
1/26 • Number of events 1 • 12 weeks after surgery
|
0.00%
0/24 • 12 weeks after surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place