Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement

Study Purpose

The aim is to demonstrate that preoperative exercises (prehabilitation) 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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 60 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06111690
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The University of Texas Health Science Center at San Antonio
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gustavo Almeida, PhD
Principal Investigator Affiliation The University of Texas Health Science Center at San Antonio
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Preoperative Exercises

Intervention is blood flow restriction training (BFRT)

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Antonio, Texas

Status

Recruiting

Address

UT Health San Antonio- Dept. of Physical Therapy

San Antonio, Texas, 78229

Site Contact

Gustavo Almeida, PhD

[email protected]

210-567-8755