Trial Outcomes & Findings for Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement (NCT NCT06111690)
NCT ID: NCT06111690
Last Updated: 2026-03-24
Results Overview
Quadricep Muscle Strength will be measured using an isokinetic dynamometer. Quadriceps femoris maximum voluntary isometric contraction (MVIC) as torque output (Nm) will be measured. Subjects will be seated in the dynamometer's chair with their knee at 60 degrees of flexion.
COMPLETED
NA
16 participants
Baseline, 8 weeks and 16 weeks
2026-03-24
Participant Flow
16 recruited; 2 did not meet in-person screening; 14 participated in the study.
The 2 participants that did not meet in-person screening had a high Ankle-brachial Index (ABI \> 1.5), which makes it unsafe to participate in blood-flow restriction training.
Participant milestones
| Measure |
Preoperative Exercises
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Preoperative Exercises
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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Overall Study
Failed in-person screening
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2
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Baseline Characteristics
Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement
Baseline characteristics by cohort
| Measure |
Preoperative Exercises
n=14 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=138 Participants
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Age, Categorical
Between 18 and 65 years
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4 Participants
n=138 Participants
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Age, Categorical
>=65 years
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10 Participants
n=138 Participants
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Age, Continuous
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70.57 years
STANDARD_DEVIATION 7.56 • n=138 Participants
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Sex: Female, Male
Female
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9 Participants
n=138 Participants
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Sex: Female, Male
Male
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5 Participants
n=138 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=138 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=138 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=138 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=138 Participants
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Race (NIH/OMB)
White
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13 Participants
n=138 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=138 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=138 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=138 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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13 Participants
n=138 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=138 Participants
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Region of Enrollment
United States
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14 Participants
n=138 Participants
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PRIMARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksQuadricep Muscle Strength will be measured using an isokinetic dynamometer. Quadriceps femoris maximum voluntary isometric contraction (MVIC) as torque output (Nm) will be measured. Subjects will be seated in the dynamometer's chair with their knee at 60 degrees of flexion.
Outcome measures
| Measure |
Preoperative Exercises
n=14 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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|---|---|
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Quadricep Muscle Strength
8-week assessment (non-surgical side)
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91.03 torque newton-meter
Standard Deviation 29.13
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Quadricep Muscle Strength
8-week assessment (surgical side)
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80.32 torque newton-meter
Standard Deviation 36.94
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Quadricep Muscle Strength
Baseline assessment (non-surgical side)
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86.15 torque newton-meter
Standard Deviation 28.39
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Quadricep Muscle Strength
Baseline assessment (surgical side)
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76.55 torque newton-meter
Standard Deviation 37.23
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Quadricep Muscle Strength
16-week assessment (non-surgical side)
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85.24 torque newton-meter
Standard Deviation 20.86
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Quadricep Muscle Strength
16-week assessment (surgical side)
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55.49 torque newton-meter
Standard Deviation 17.57
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PRIMARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksPopulation: The discrepancy in number of participants included (N=14) versus the number of participants analyzed in this outcome (n=7) is due to unavailability of the DXA scanner in the beginning of the study. Of note, all missed measures were reported to the IRB.
Leg muscles % fat mass will be measured using a DXA scan.
Outcome measures
| Measure |
Preoperative Exercises
n=7 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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|---|---|
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Leg Muscles Percentage of Fat Mass
Baseline %Fat (non-surgical side)
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47.88 Percentage
Standard Deviation 3.42
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Leg Muscles Percentage of Fat Mass
Baseline %Fat (surgical side)
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47.28 Percentage
Standard Deviation 3.31
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Leg Muscles Percentage of Fat Mass
8-week %Fat (non-surgical)
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46.64 Percentage
Standard Deviation 7.27
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Leg Muscles Percentage of Fat Mass
8-week %Fat (surgical)
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45.94 Percentage
Standard Deviation 7.53
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Leg Muscles Percentage of Fat Mass
16-week %Fat (non-surgical side)
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47.00 Percentage
Standard Deviation 6.92
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Leg Muscles Percentage of Fat Mass
16-week %Fat (surgical side)
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47.03 Percentage
Standard Deviation 6.90
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PRIMARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksPopulation: The discrepancy in number of participants included (N=14) versus the number of participants analyzed in this outcome (n=7) is due to unavailability of the DXA scanner in the beginning of the study. Of note, all missed measures were reported to the IRB.
Leg muscles lean mass in kilograms will be measured using a DXA scan.
Outcome measures
| Measure |
Preoperative Exercises
n=7 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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|---|---|
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Leg Muscles Lean Mass in Kilograms
Baseline_LeanMass (non-surgical)
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5.47 Kilograms
Standard Deviation 4.08
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Leg Muscles Lean Mass in Kilograms
Baseline_LeanMass (surgical)
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5.63 Kilograms
Standard Deviation 4.13
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Leg Muscles Lean Mass in Kilograms
8-week_LeanMass (non-surgical)
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7.92 Kilograms
Standard Deviation 1.36
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Leg Muscles Lean Mass in Kilograms
8-week_LeanMass (surgical)
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7.98 Kilograms
Standard Deviation 1.15
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Leg Muscles Lean Mass in Kilograms
16-week_LeanMass (non-surgical)
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7.78 Kilograms
Standard Deviation 1.31
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Leg Muscles Lean Mass in Kilograms
16-week_LeanMass (surgical)
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7.85 Kilograms
Standard Deviation 1.10
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SECONDARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksSubject will walk a 4-meter walkway at a self-selected pace. Time to complete task will be recorded.
Outcome measures
| Measure |
Preoperative Exercises
n=14 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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Self-selected Gait Speed
Baseline assessment
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0.91 meters per second
Standard Deviation 0.21
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Self-selected Gait Speed
8-week assessment
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0.93 meters per second
Standard Deviation 0.19
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Self-selected Gait Speed
16-week assessment
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0.88 meters per second
Standard Deviation 0.21
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SECONDARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksSubject will get up from a chair, walk 3 meters, turn around and walk back to and sit on the chair. Time to complete task will be recorded.
Outcome measures
| Measure |
Preoperative Exercises
n=14 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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Timed up and go Test
Baseline assessment
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13.90 Seconds
Standard Deviation 6.61
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Timed up and go Test
8-week assessment
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12.47 Seconds
Standard Deviation 4.03
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Timed up and go Test
16-week assessment
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12.83 Seconds
Standard Deviation 4.25
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SECONDARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksSubject will perform sit-to-stand from a standard chair for 30 seconds. Number of times of completed sit-to-stand in 30 seconds will be recorded.
Outcome measures
| Measure |
Preoperative Exercises
n=14 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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30-second Chair Stand Test
Baseline assessment
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7.50 Units (number of times standing up)
Standard Deviation 3.06
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30-second Chair Stand Test
8-week assessment
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9.07 Units (number of times standing up)
Standard Deviation 3.79
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30-second Chair Stand Test
16-week assessment
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7.86 Units (number of times standing up)
Standard Deviation 3.53
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SECONDARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksSubject will climb up and down a flight of stairs (11 steps). Time to complete task will be recorded.
Outcome measures
| Measure |
Preoperative Exercises
n=14 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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|---|---|
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Stair Climb Test
Baseline assessment
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34.36 Seconds
Standard Deviation 32.09
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Stair Climb Test
8-week assessment
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28.34 Seconds
Standard Deviation 23.13
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Stair Climb Test
16-week assessment
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37.15 Seconds
Standard Deviation 27.85
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SECONDARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksSubjects will cover as much as they can while walking on a flat, unobstructed path for 6 minutes.
Outcome measures
| Measure |
Preoperative Exercises
n=14 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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|---|---|
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6-minute Walk Test
8-week assessment
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395.87 meters
Standard Deviation 108.73
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6-minute Walk Test
16-week assessment
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346.59 meters
Standard Deviation 110.13
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6-minute Walk Test
Baseline assessment
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369.43 meters
Standard Deviation 119.00
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SECONDARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksPatient-Reported Physical Outcome will be assessed using PROMIS® (Patient-Reported Outcomes Measurement Information System), which is used to evaluate and monitor physical, mental, and social health in persons with several conditions. This is a 20 item survey with each item scored from 1-5. Total possible scores range from 5-100 with a higher score indicating better physical function.
Outcome measures
| Measure |
Preoperative Exercises
n=14 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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|---|---|
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Patient-Reported Physical Outcomes Measurement Information System (PROMIS
Baseline assessment
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60.00 Score
Standard Deviation 22.19
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Patient-Reported Physical Outcomes Measurement Information System (PROMIS
8-week assessment
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57.50 Score
Standard Deviation 19.78
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Patient-Reported Physical Outcomes Measurement Information System (PROMIS
16-week assessment
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56.15 Score
Standard Deviation 25.51
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SECONDARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksThe RAND-36 Questionnaire is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions. All questions are scored on a scale from 0 (worst) to 100 (best), with 100 representing the highest level of functioning possible. Aggregate scores are calculated between 0-100 with higher scores representing better quality of life.
Outcome measures
| Measure |
Preoperative Exercises
n=14 Participants
Intervention is blood flow restriction training (BFRT)
Blood Flow Restriction Training (BFRT): Participants will be performing low-resistance exercise with (BFRT). Intervention will start at least seven days after initial evaluation, so it does not influence measures of real-time physical activity. We will use a log to register exercise completion and to record bilateral knee pain before, during and after each intervention session
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Health Related Quality of Life (RAND-36)
Baseline assessment
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71.79 Score
Standard Deviation 16.01
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Health Related Quality of Life (RAND-36)
8-week assessment
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71.07 Score
Standard Deviation 16.78
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Health Related Quality of Life (RAND-36)
16-week assessment
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76.54 Score
Standard Deviation 15.99
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SECONDARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksAn activity monitor will be worn for 7 days and physical activity (i.e., daily number of steps) will be tracked.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 8 weeks and 16 weeksChange in 'MILLIPLEX® MAP Human High Sensitivity T Cell Magnetic Bead Panel' to assess a panel of 8 inflammatory biomarkers: Interleukin (IL)-1β, IL-2, IL-5, IL-6, IL-10, IL-12p70, IL-13 and Interferon-γ.
Outcome measures
Outcome data not reported
Adverse Events
Preoperative Exercises
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gustavo Almeida
University of Texas at San Antonio, Health Sciences Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place