Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement

NCT ID: NCT06111690

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-23
• Study Completion Date: 2024-12-02

Brief Summary

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).

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Preoperative Exercises

Intervention is blood flow restriction training (BFRT)

Group Type: EXPERIMENTAL

Blood Flow Restriction Training (BFRT)

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

BFRT

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Gustavo Almeida

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustavo Almeida, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

UT Health San Antonio- Dept. of Physical Therapy

San Antonio, Texas, United States

Countries

United States

Other Identifiers

5P30AG044271

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20210590H

Identifier Type: -

Identifier Source: org_study_id