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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG044271 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The aim is to demonstrate that preoperative exercises (pre-habilitation) using blood-flow restriction training (BFRT) is safe, well tolerated, improves muscle function, decreases functional limitation, and increases physical activity in older adults awaiting total knee replacement (TKR).
Twenty individuals ≥60 years old awaiting TKR due to diagnosis of end-stage knee osteoarthritis who meet the inclusion/exclusion criteria will be invited to participate in a 6 weeks of low-intensity BFRT prehabilitation. We will assess muscle functional (i.e., cross-sectional area and intramuscular fatty content) using computerized tomography, quadriceps muscle strength using an isokinetic dynamometer, a battery of performance-based physical function, self-reported physical function and quality of life, and biomarkers of inflammation using blood serum. Feasibility assessment will be done by looking at safety (i.e., adverse events), compliance, and attrition rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Exercises | Experimental | Intervention is blood flow restriction training (BFRT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction Training (BFRT) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quadricep Muscle Strength | 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. | Baseline, 8 weeks and 16 weeks |
| Leg Muscles Percentage of Fat Mass | Leg muscles % fat mass will be measured using a DXA scan. | Baseline, 8 weeks and 16 weeks |
| Leg Muscles Lean Mass in Kilograms | Leg muscles lean mass in kilograms will be measured using a DXA scan. | Baseline, 8 weeks and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-selected Gait Speed | Subject will walk a 4-meter walkway at a self-selected pace. Time to complete task will be recorded. | Baseline, 8 weeks and 16 weeks |
| Timed up and go Test | Subject 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustavo Almeida, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health San Antonio- Dept. of Physical Therapy | San Antonio | Texas | 78229 | United States |
Deidentified data will be shared with other researchers at UT Health San Antonio, with the NIH and on ClinicalTrials.gov
Data will become available after summary result publication on ClinicalTrials.gov and when published in a peer review journal
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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.
16 recruited; 2 did not meet in-person screening; 14 participated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quadricep Muscle Strength | 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. | Posted | Mean | Standard Deviation | torque newton-meter | Baseline, 8 weeks and 16 weeks |
|
Baseline to 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gustavo Almeida | University of Texas at San Antonio, Health Sciences Center | 4123781951 | almeidag@uthscsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2024 | Feb 2, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 5, 2024 | Feb 2, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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This is a single group pre-post design study
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|
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| Baseline, 8 weeks and 16 weeks |
| 30-second Chair Stand Test | Subject 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. | Baseline, 8 weeks and 16 weeks |
| Stair Climb Test | Subject will climb up and down a flight of stairs (11 steps). Time to complete task will be recorded. | Baseline, 8 weeks and 16 weeks |
| 6-minute Walk Test | Subjects will cover as much as they can while walking on a flat, unobstructed path for 6 minutes. | Baseline, 8 weeks and 16 weeks |
| Patient-Reported Physical Outcomes Measurement Information System (PROMIS | Patient-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. | Baseline, 8 weeks and 16 weeks |
| Health Related Quality of Life (RAND-36) | The 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. | Baseline, 8 weeks and 16 weeks |
| Real-time Physical Activity | An activity monitor will be worn for 7 days and physical activity (i.e., daily number of steps) will be tracked. | Baseline, 8 weeks and 16 weeks |
| Inflammatory Biomarkers | Change 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. | Baseline, 8 weeks and 16 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Leg Muscles Percentage of Fat Mass | Leg muscles % fat mass will be measured using a DXA scan. | 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. | Posted | Mean | Standard Deviation | Percentage | Baseline, 8 weeks and 16 weeks |
|
|
|
| Primary | Leg Muscles Lean Mass in Kilograms | Leg muscles lean mass in kilograms will be measured using a DXA scan. | 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. | Posted | Mean | Standard Deviation | Kilograms | Baseline, 8 weeks and 16 weeks |
|
|
|
| Secondary | Self-selected Gait Speed | Subject will walk a 4-meter walkway at a self-selected pace. Time to complete task will be recorded. | Posted | Mean | Standard Deviation | meters per second | Baseline, 8 weeks and 16 weeks |
|
|
|
| Secondary | Timed up and go Test | Subject 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. | Posted | Mean | Standard Deviation | Seconds | Baseline, 8 weeks and 16 weeks |
|
|
|
| Secondary | 30-second Chair Stand Test | Subject 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. | Posted | Mean | Standard Deviation | Units (number of times standing up) | Baseline, 8 weeks and 16 weeks |
|
|
|
| Secondary | Stair Climb Test | Subject will climb up and down a flight of stairs (11 steps). Time to complete task will be recorded. | Posted | Mean | Standard Deviation | Seconds | Baseline, 8 weeks and 16 weeks |
|
|
|
| Secondary | 6-minute Walk Test | Subjects will cover as much as they can while walking on a flat, unobstructed path for 6 minutes. | Posted | Mean | Standard Deviation | meters | Baseline, 8 weeks and 16 weeks |
|
|
|
| Secondary | Patient-Reported Physical Outcomes Measurement Information System (PROMIS | Patient-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. | Posted | Mean | Standard Deviation | Score | Baseline, 8 weeks and 16 weeks |
|
|
|
| Secondary | Health Related Quality of Life (RAND-36) | The 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. | Posted | Mean | Standard Deviation | Score | Baseline, 8 weeks and 16 weeks |
|
|
|
| Secondary | Real-time Physical Activity | An activity monitor will be worn for 7 days and physical activity (i.e., daily number of steps) will be tracked. | Not Posted | Baseline, 8 weeks and 16 weeks | Participants |
| Secondary | Inflammatory Biomarkers | Change 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. | Not Posted | Baseline, 8 weeks and 16 weeks | Participants |
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| 8-week %Fat (surgical) |
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| 16-week %Fat (non-surgical side) |
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| 16-week %Fat (surgical side) |
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| 8-week_LeanMass (surgical) |
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| 16-week_LeanMass (non-surgical) |
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| 16-week_LeanMass (surgical) |
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