Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement

NCT06111690 | Completed Results DMC

• 2 other identifiers: HSC20210590H5P30AG044271
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Knee Osteoarthritis

Keywords

Blood flow restriction training (BFRT); Preoperative exercise; Muscle function; Physical activity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Self-selected Gait Speed

  Baseline, 8 weeks and 16 weeks

• Timed up and go Test

  Baseline, 8 weeks and 16 weeks

• 30-second Chair Stand Test

  Baseline, 8 weeks and 16 weeks

• Stair Climb Test

  Baseline, 8 weeks and 16 weeks

• 6-minute Walk Test

  Baseline, 8 weeks and 16 weeks

Study Arms (1)

Preoperative Exercises

EXPERIMENTAL

Intervention is blood flow restriction training (BFRT)

Procedure: Blood Flow Restriction Training (BFRT)

Interventions

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

Also known as: BFRT

Preoperative Exercises

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health San Antonio- Dept. of Physical Therapy

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Dr. Gustavo Almeida
• Organization: University of Texas at San Antonio, Health Sciences Center

almeidag@uthscsa.edu

4123781951

Study Officials

• Gustavo Almeida, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a single group pre-post design study

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: September 23, 2022
• Primary Completion: October 2, 2024
• Study Completion: December 2, 2024
• Last Updated: March 24, 2026
• Results First Posted: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available after summary result publication on ClinicalTrials.gov and when published in a peer review journal

Locations

US (1)