UT Health San Antonio- Dept. of Physical Therapy
San Antonio, Texas, 78229, United States
NCT Number: NCT06111690
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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Notify Me60 year and older
All sexes
Interventional
Not applicable
San Antonio, Texas, 78229, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: Baseline, 8 weeks and 16 weeks
Leg muscles % fat mass will be measured using a DXA scan.
Time frame: Baseline, 8 weeks and 16 weeks
Leg muscles lean mass in kilograms will be measured using a DXA scan.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The University of Texas Health Science Center at San Antonio
Other
Feasibility of Prehabilitation Blood-flow Restriction Training in Individuals Awaiting Total Knee Replacement.
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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