Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement

Feasibility of Prehabilitation Blood-flow Restriction Training in Individuals Awaiting Total Knee Replacement.

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).

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Blood Flow Restriction Training (BFRT)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio- Dept. of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants are awaiting primary unilateral TKR due to diagnosis of end-stage KOA. Potential individuals must have at least 8 weeks waiting time in between study baseline assessment and surgery. This 8-week timeframe will allow for completion of baseline (T0) and follow-up assessments (T1: immediately after 6-week prehabilitation program);
2. are older than 60 years;
3. speak fluent English to reliably complete the study questionnaires and understand study instructions.

Exclusion Criteria:

1. have a history of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), deep-vein thrombosis, varicose veins, or rhabdomyolysis;
2. have absolute contraindications to exercise, as established by the American College of Sports Medicine (uncontrolled arrhythmias, third degree heart block, recent EKG changes, unstable angina, acute myocardial infarction, and acute congestive heart failure);
3. report of 2 or more falls within the past year;
4. cannot walk a distance of 100 feet (30.5 meters) without an assistive device or need of a rest period;
5. have bilateral TKR or undergoing TKR revision or other total joint replacement in the lower extremities; or
6. have severe visual or hearing impairment. In addition to the affects that these impairments have on safety during participation in the intervention, they may also interfere with data collection (questionnaires and telephone checks);
7. have a lower extremity amputation;
8. are unable to comfortably bear weight on the affected knee;
9. have a BMI above 40.
10. history of muscular disease (e.g., muscular dystrophy) or neurological disorder that may affect lower extremity function (e.g., cerebrovascular accident, neuropathy, Parkinson's disease, multiple sclerosis);
11. had additional surgery to the lower extremities within the past 12 months.
12. a Folstein Mini-Mental State Examination score of <24.
13. have acute or terminal illness;
14. are planning to have another TKR (primary on contralateral, or revision on same knee) within 4 months;
15. are planning to relocate to another city within 4 months.
16. Subjects with Sickle cell disease
17. lymphedema or vascular access restrictions
18. Subjects who have any on-going medical emergency
19. An ankle-brachial index outside of the expected range 0.9 and 1.3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Preoperative Exercises; Intervention is blood flow restriction training (BFRT)

Procedure: 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; Other Names: BFRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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
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
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
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Gustavo Almeida, PhD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Actual): October 2, 2024
• Study Completion (Actual): December 2, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Physical activity; Muscle function; Blood flow restriction training (BFRT); Preoperative exercise
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Behavior; Osteoarthritis, Knee; Motor Activity; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Blood Flow Restriction Therapy
• Other Study ID Numbers: HSC20210590H; 5P30AG044271 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be shared with other researchers at UT Health San Antonio, with the NIH and on ClinicalTrials.gov
• IPD Sharing Time Frame: Data will become available after summary result publication on ClinicalTrials.gov and when published in a peer review journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No