CompletedNot Applicable

Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement

United States16 participantsStarted 2022-09-23

Plain-language 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).

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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);
✕

What they're measuring

Quadricep Muscle Strength

Timeframe: Baseline, 8 weeks and 16 weeks

Leg Muscles Percentage of Fat Mass

Timeframe: Baseline, 8 weeks and 16 weeks

Leg Muscles Lean Mass in Kilograms

Timeframe: Baseline, 8 weeks and 16 weeks

Trial details

NCT IDNCT06111690

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-02

Results submitted2026-02-11

View on ClinicalTrials.gov More Knee Osteoarthritis trials

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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);
✕