Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement

Knee Osteoarthritis Clinical Trial

Official title:

Feasibility of Prehabilitation Blood-flow Restriction Training in Individuals Awaiting Total Knee Replacement.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111690
• Other study ID #: HSC20210590H
• Secondary ID: 5P30AG044271
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Gustavo Almeida, PhD
• Phone: 210-567-8755
• Email: almeidag[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	UT Health San Antonio- Dept. of Physical Therapy	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadricep Muscle Strength	Changes in 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
Primary	Thigh muscles composition	Change in thigh muscles % fat-free mass and % fat mass will be measured using a DXA scan.	Baseline, 8 weeks and 16 weeks
Primary	Thigh muscle volume	Change in thigh muscles cross-sectional area (volume) will be measured using a DXA scan.	Baseline, 8 weeks and 16 weeks
Secondary	Self-selected Gait Speed	Subject will walk a 4-meter walkway at a self-selected pace. Time to complete task will be recorded.	Baseline, 8 weeks and 16 weeks
Secondary	Timed up and go Test	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.	Baseline, 8 weeks and 16 weeks
Secondary	30-second chair stand test	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.	Baseline, 8 weeks and 16 weeks
Secondary	Stair climb test	Subject will climb up and down a flight of stairs (11 steps). Time to complete task will be recorded.	Baseline, 8 weeks and 16 weeks
Secondary	6-minute Walk Test	Subjects will cover as much as they can while walking on a flat, unobstructed path for 6 minutes.	Baseline, 8 weeks and 16 weeks
Secondary	Patient-Reported Physical Outcome	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.	Baseline, 8 weeks and 16 weeks
Secondary	Health Related Quality of Life (RAND-36)	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.	Baseline, 8 weeks and 16 weeks
Secondary	Real-time Physical Activity	An activity monitor will be worn for 7 days and physical activity (i.e., daily number of steps) will be tracked.	Baseline, 8 weeks and 16 weeks
Secondary	Inflammatory Biomarkers	Change in 'MILLIPLEX® MAP Human High Sensitivity T Cell Magnetic Bead Panel' to assess a panel of 8 inflammatory biomarkers: Interleukin (IL)-1ß, IL-2, IL-5, IL-6, IL-10, IL-12p70, IL-13 and Interferon-?.	Baseline, 8 weeks and 16 weeks