An interventional study of Strength testing and Short Physical Performance Battery (SPPB) in Osteoarthritis, Knee, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by University of Florida · Not applicable, Interventional, and Health services research
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 12 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Strength testing · Behavioral: Short Physical Performance Battery (SPPB) · Behavioral: Six-minute walk (SMW) · Behavioral: Numerical pain scale · Behavioral: Self-assessed function · Procedure: Muscle biopsies
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.
Device: Strength testing · Behavioral: Short Physical Performance Battery (SPPB) · Behavioral: Six-minute walk (SMW) · Behavioral: Numerical pain scale · Behavioral: Self-assessed function · Procedure: Muscle biopsies · Device: Determination of 1 Repetition Maximum (1-RM) · Device: Blood flow restriction exercise · Behavioral: Borg CR10 scale
Test the strength of subject's lower extremity muscles on the dynamometer system
The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.
Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.
Measure pain using an 11-point numerical pain scale.
Using the Late Life Function and Disability Instrument.
During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.
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.
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.
Following each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale.
Changes between the two group assessed by muscle strength
Test the strength of subject's lower extremity muscles on the dynamometer system
Time frame: Changes from baseline (pre-op) up to 2 weeks post-op
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.
Time frame: Changes from baseline (pre-op) up to 2 weeks post-op
Changes between the two group assessed by Six-minute walk (SMW) test
SPPB is a validated test to measure lower extremity function a timed short distance walk, repeated chair stands, and balance test.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Up to 4 hours (end of surgery)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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