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Completed

NCT Number: NCT06111690

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).

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Health San Antonio- Dept. of Physical Therapy

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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);
  • are older than 60 years;
  • speak fluent English to reliably complete the study questionnaires and understand study instructions.

Exclusion criteria

  • have a history of cardiovascular disease, uncontrolled hypertension (blood pressure ≥140/90 mmHg), deep-vein thrombosis, varicose veins, or rhabdomyolysis;
  • 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);
  • report of 2 or more falls within the past year;
  • cannot walk a distance of 100 feet (30.5 meters) without an assistive device or need of a rest period;
  • have bilateral TKR or undergoing TKR revision or other total joint replacement in the lower extremities; or
  • 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);
  • have a lower extremity amputation;
  • are unable to comfortably bear weight on the affected knee;
  • have a BMI above 40.
  • 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);
  • had additional surgery to the lower extremities within the past 12 months.
  • a Folstein Mini-Mental State Examination score of <24.
  • have acute or terminal illness;
  • are planning to have another TKR (primary on contralateral, or revision on same knee) within 4 months;
  • are planning to relocate to another city within 4 months.
  • Subjects with Sickle cell disease
  • lymphedema or vascular access restrictions
  • Subjects who have any on-going medical emergency
  • An ankle-brachial index outside of the expected range 0.9 and 1.3

Treatment and study plan

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

Other names: BFRT

Primary outcomes

  1. Quadricep Muscle Strength

    Time frame: Baseline, 8 weeks and 16 weeks

    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.

  2. Leg Muscles Percentage of Fat Mass

    Time frame: Baseline, 8 weeks and 16 weeks

    Leg muscles % fat mass will be measured using a DXA scan.

  3. Leg Muscles Lean Mass in Kilograms

    Time frame: Baseline, 8 weeks and 16 weeks

    Leg muscles lean mass in kilograms will be measured using a DXA scan.

Secondary outcomes

  1. Self-selected Gait Speed

    Time frame: Baseline, 8 weeks and 16 weeks

    Subject will walk a 4-meter walkway at a self-selected pace. Time to complete task will be recorded.

  2. Timed up and go Test

    Time frame: Baseline, 8 weeks and 16 weeks

    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.

  3. 30-second Chair Stand Test

    Time frame: Baseline, 8 weeks and 16 weeks

    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.

  4. Stair Climb Test

    Time frame: Baseline, 8 weeks and 16 weeks

    Subject will climb up and down a flight of stairs (11 steps). Time to complete task will be recorded.

  5. 6-minute Walk Test

    Time frame: Baseline, 8 weeks and 16 weeks

    Subjects will cover as much as they can while walking on a flat, unobstructed path for 6 minutes.

  6. Patient-Reported Physical Outcomes Measurement Information System (PROMIS

    Time frame: Baseline, 8 weeks and 16 weeks

    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.

  7. Health Related Quality of Life (RAND-36)

    Time frame: Baseline, 8 weeks and 16 weeks

    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.

  8. Real-time Physical Activity

    Time frame: Baseline, 8 weeks and 16 weeks

    An activity monitor will be worn for 7 days and physical activity (i.e., daily number of steps) will be tracked.

  9. Inflammatory Biomarkers

    Time frame: Baseline, 8 weeks and 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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