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This pilot study will investigate the effects of blood flow restriction (BFR) exercise for up to 4-6 weeks prior to total knee arthroplasty (TKA) surgery in older patients to measure clinical outcomes such as strength, lower extremity function, and pain.
The purpose of this study is to test the feasibility and efficacy of a low-resistance exercise protocol with blood flow restriction (BFR) using a tourniquet in the preoperative period of patients awaiting TKA. BFR exercise is a new exercise method that has not been studied in the perioperative period. The investigators will compare our intervention to a no-exercise group up to 4 - 6 weeks prior to surgery to determine if this type of exercise is feasible in the preoperative period and if BFR exercise will improve functional, physiological, and molecular outcomes when compared to patients without exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NO-EX group | Placebo Comparator | Subjects allocated to the No Exercise (NO-EX) group will undergo: Strength testing, Short Physical Performance Battery (SPPB), Six-minute walk (SMW), Numerical pain scale, Self-assessed function and Six-minute walk (SMW) test. Intra-op muscle biopsies. |
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| EX-BFR group | Experimental | Subjects allocated to the EX-BFR group will undergo baseline strength testing, Short Physical Performance Battery (SPPB), Numerical pain scale, Six-minute walk (SMW), Self-assessed function, and determination of 1 Repetition Maximum (1-RM). Blood flow restriction exercise, Borg Category Ratio 10 (Borg CR10) scale. Intra-op muscle biopsies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strength testing | Device | Test the strength of subject's lower extremity muscles on the dynamometer system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes between the two group assessed by muscle strength | Test the strength of subject's lower extremity muscles on the dynamometer system | Changes from baseline (pre-op) up to 2 weeks post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Changes between the two group assessed by Short Physical Performance Battery (SPPB) | SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test. | Changes from baseline (pre-op) up to 2 weeks post-op |
| Changes between the two group assessed by Six-minute walk (SMW) test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rene Przkora, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States, Florida UF Health | Gainesville | Florida | 32610-3003 | United States |
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| Short Physical Performance Battery (SPPB) | Behavioral | The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function. |
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| Six-minute walk (SMW) | Behavioral | Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible. |
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| Numerical pain scale | Behavioral | Measure pain using an 11-point numerical pain scale. |
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| Self-assessed function | Behavioral | Using the Late Life Function and Disability Instrument. |
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| Muscle biopsies | Procedure | During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected. |
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| Determination of 1 Repetition Maximum (1-RM) | Device | Following the warm-up, subjects will attempt to complete one repetition of the leg press exercise at progressively greater resistance until a full repetition can no longer be performed. The weight of the last complete unassisted repetition will be recorded as the 1-RM. |
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| Blood flow restriction exercise | Device | Perform lower-extremity exercises (leg press, leg extension, leg curl, and calf extension) at an intensity of 30% of 1-RM with external compression applied to the proximal thigh of each leg. |
|
| Borg CR10 scale | Behavioral | Following each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale. |
|
SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test. |
| Changes from baseline (pre-op) up to 2 weeks post-op |
| Changes between the two group assessed by pain | Measure pain using an 11-point numerical pain scale | Changes from baseline (pre-op) up to 2 weeks post-op |
| Changes between the two group assessed by self-assessment outcomes | Assessed using the Late Life Function and Disability Instrument | Changes from baseline (pre-op) up to 2 weeks post-op |
| Changes between the two group assessed by biological targets on the muscle tissue | Analysis of the muscle tissue will focus on metabolism, inflammation, autophagy, apoptosis and other mechanisms of muscular atrophy. | Up to 4 hours (end of surgery) |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016138 | Walking |
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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