Trial Outcomes & Findings for Low-Load Blood Flow Restriction Training vs Traditional Resistance Training Exercises Following ACLR Surgery (NCT NCT06480032)
NCT ID: NCT06480032
Last Updated: 2025-08-15
Results Overview
Knee range of motion assessed weekly for eight consecutive weeks with the patient in a supine position using goniometer.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
eight weeks
Results posted on
2025-08-15
Participant Flow
Medical hospital
There were no excluded participants of enrolled groups during data collection.
Participant milestones
| Measure |
Non-Blood Flow Restriction Band
Group B, comprising 16 patients (Group 2), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol without Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit. The cuff size determined based on the patient's thigh circumference.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
Blood Flow Restriction band: Blood Flow Restriction (BFR) band operate by partially occluding arterial blood flow to distal structures, but more significantly impeding venous outflow from under the cuff, thereby also hindering venous return. The compression of vasculature proximal to the skeletal muscle leads to inadequate oxygen supply (hypoxia) within the muscle tissue, resulting in a localized hypoxic environment. Additionally, the reduction in venous blood flow causes blood to accumulate in the capillaries of the occluded limb, often manifesting as visible erythema. This temporary restriction will be maintained for a duration of 8 weeks.
|
Blood Flow Restriction Band
Group 1, comprising 16 patients (Group 1), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol with Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit. The cuff size determined based on the patient's thigh circumference.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
Blood Flow Restriction band: Blood Flow Restriction (BFR) band operate by partially occluding arterial blood flow to distal structures, but more significantly impeding venous outflow from under the cuff, thereby also hindering venous return. The compression of vasculature proximal to the skeletal muscle leads to inadequate oxygen supply (hypoxia) within the muscle tissue, resulting in a localized hypoxic environment. Additionally, the reduction in venous blood flow causes blood to accumulate in the capillaries of the occluded limb, often manifesting as visible erythema. This temporary restriction will be maintained for a duration of 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non-Blood Flow Restriction Band
n=16 Participants
Group B, comprising 16 patients (Group 2), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol without Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit. The cuff size determined based on the patient's thigh circumference.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
Blood Flow Restriction band: Blood Flow Restriction (BFR) band operate by partially occluding arterial blood flow to distal structures, but more significantly impeding venous outflow from under the cuff, thereby also hindering venous return. The compression of vasculature proximal to the skeletal muscle leads to inadequate oxygen supply (hypoxia) within the muscle tissue, resulting in a localized hypoxic environment. Additionally, the reduction in venous blood flow causes blood to accumulate in the capillaries of the occluded limb, often manifesting as visible erythema. This temporary restriction will be maintained for a duration of 8 weeks.
|
Blood Flow Restriction Band
n=16 Participants
Group 1, comprising 16 patients (Group 1), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol with Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit. The cuff size determined based on the patient's thigh circumference.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
Blood Flow Restriction band: Blood Flow Restriction (BFR) band operate by partially occluding arterial blood flow to distal structures, but more significantly impeding venous outflow from under the cuff, thereby also hindering venous return. The compression of vasculature proximal to the skeletal muscle leads to inadequate oxygen supply (hypoxia) within the muscle tissue, resulting in a localized hypoxic environment. Additionally, the reduction in venous blood flow causes blood to accumulate in the capillaries of the occluded limb, often manifesting as visible erythema. This temporary restriction will be maintained for a duration of 8 weeks.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=16 Participants
|
16 Participants
n=16 Participants
|
32 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=16 Participants
|
2 Participants
n=16 Participants
|
7 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=16 Participants
|
14 Participants
n=16 Participants
|
25 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Pakistan
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: eight weeksKnee range of motion assessed weekly for eight consecutive weeks with the patient in a supine position using goniometer.
Outcome measures
| Measure |
Blood Flow Restriction Band
n=16 Participants
Group 1, comprising 16 patients (Group 1), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol with Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
Blood Flow Restriction band: Blood Flow Restriction (BFR) band operate by partially occluding arterial blood flow to distal structures, but more significantly impeding venous outflow from under the cuff, thereby also hindering venous return. The compression of vasculature proximal to the skeletal muscle leads to inadequate oxygen supply (hypoxia) within the muscle tissue, resulting in a localized hypoxic environment.
|
Non-Blood Flow Restriction Band
n=16 Participants
Group B, comprising 16 patients (Group 2), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol without Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit. The cuff size determined based on the patient's thigh circumference.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
|
|---|---|---|
|
Range of Motion
|
74.0625 Degrees
Standard Deviation 14.04976
|
80.3125 Degrees
Standard Deviation 14.65933
|
PRIMARY outcome
Timeframe: eight weeksStrength assessed through manual muscle testing (MMT). The grading scale ranges from 0 to 5, with Grade 0 indicating no visible or palpable muscle contraction and Grade 5 indicates muscle movement against gravity and maximal resistance.
Outcome measures
| Measure |
Blood Flow Restriction Band
n=16 Participants
Group 1, comprising 16 patients (Group 1), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol with Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
Blood Flow Restriction band: Blood Flow Restriction (BFR) band operate by partially occluding arterial blood flow to distal structures, but more significantly impeding venous outflow from under the cuff, thereby also hindering venous return. The compression of vasculature proximal to the skeletal muscle leads to inadequate oxygen supply (hypoxia) within the muscle tissue, resulting in a localized hypoxic environment.
|
Non-Blood Flow Restriction Band
n=16 Participants
Group B, comprising 16 patients (Group 2), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol without Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit. The cuff size determined based on the patient's thigh circumference.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
|
|---|---|---|
|
Quadricep Strength
|
3.9375 units on a scale
Standard Deviation 3.5
|
.6800735 units on a scale
Standard Deviation .5163978
|
PRIMARY outcome
Timeframe: eight weeksPain was assessed using visual analogue scale. This questionnaire ranges 0 to 10, where 10 indicates the worst pain and 0 indicates no pain. A higher score reflects higher pain.
Outcome measures
| Measure |
Blood Flow Restriction Band
n=16 Participants
Group 1, comprising 16 patients (Group 1), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol with Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
Blood Flow Restriction band: Blood Flow Restriction (BFR) band operate by partially occluding arterial blood flow to distal structures, but more significantly impeding venous outflow from under the cuff, thereby also hindering venous return. The compression of vasculature proximal to the skeletal muscle leads to inadequate oxygen supply (hypoxia) within the muscle tissue, resulting in a localized hypoxic environment.
|
Non-Blood Flow Restriction Band
n=16 Participants
Group B, comprising 16 patients (Group 2), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol without Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit. The cuff size determined based on the patient's thigh circumference.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
|
|---|---|---|
|
Knee Pain
|
2.0625 units on a scale
Standard Deviation 1.12361
|
1.9375 units on a scale
Standard Deviation 1.340087
|
PRIMARY outcome
Timeframe: eight weeksMuscle size assessed using measuring tap wrapping around the thigh of pre-patellar region.
Outcome measures
| Measure |
Blood Flow Restriction Band
n=16 Participants
Group 1, comprising 16 patients (Group 1), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol with Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
Blood Flow Restriction band: Blood Flow Restriction (BFR) band operate by partially occluding arterial blood flow to distal structures, but more significantly impeding venous outflow from under the cuff, thereby also hindering venous return. The compression of vasculature proximal to the skeletal muscle leads to inadequate oxygen supply (hypoxia) within the muscle tissue, resulting in a localized hypoxic environment.
|
Non-Blood Flow Restriction Band
n=16 Participants
Group B, comprising 16 patients (Group 2), undergo the standard Anterior Cruciate Ligament (ACL) rehabilitation protocol without Blood Flow Restriction (BFR) for 8 weeks during their physiotherapy sessions at the Rehman Medical Institute's Outpatient Department (OPD), starting from the second post-operative visit. The cuff size determined based on the patient's thigh circumference.
The rehabilitation protocol will progress as follows:
* Week 2-4: Long Arc Quadriceps (LAQ) exercise progression, Shuttle exercise progression, and Post-op visit 2.
* Week 4-8: Available range LAQ, Standing terminal knee extension, and Single Limb Shuttle/Leg Press exercises.
|
|---|---|---|
|
Quadricep Size
|
19.375 cm
Standard Deviation 2.028957
|
18.65625 cm
Standard Deviation 2.650275
|
Adverse Events
Blood Flow Restriction Band
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Blood Flow Restriction Band
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