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Behavioural Intervention

Blood Flow Restriction Training for Osteoarthritis

N/A
Recruiting
Led By Gustavo Almeida, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants are awaiting primary unilateral TKR due to diagnosis of end-stage KOA
Participants are older than 60 years
Must not have
Participants cannot walk a distance of 100 feet (30.5 meters) without an assistive device or need of a rest period
Participants have severe visual or hearing impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks and 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial shows prehab using BFRT can help older adults awaiting TKR with muscle function, physical activity, and functional limitation.

Who is the study for?
This trial is for individuals over 60 years old who are fluent in English and awaiting a primary unilateral total knee replacement with at least an 8-week wait before surgery. They must be able to walk without assistance and have no history of severe cardiovascular disease, uncontrolled high blood pressure, deep-vein thrombosis, or other major health issues like muscular diseases.
What is being tested?
The study tests if Blood Flow Restriction Training (BFRT) can safely improve muscle function and physical activity in older adults before they undergo knee replacement surgery. Participants will complete a prehabilitation program using BFRT for six weeks prior to their operation.
What are the potential side effects?
While the trial aims to prove safety, potential side effects may include discomfort during training, temporary changes in skin color or sensation due to restricted blood flow, muscle fatigue or soreness after exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am waiting for a knee replacement due to severe knee arthritis.
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I am older than 60 years.
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I speak and understand English well enough to follow study instructions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot walk 100 feet without help or needing to rest.
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I have severe problems with my vision or hearing.
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I have rhabdomyolysis.
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I have Sickle cell disease.
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My BMI is above 40.
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I have a history of heart disease.
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I have had an amputation of a lower limb.
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I cannot put weight on my affected knee without discomfort.
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I have deep-vein thrombosis.
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I have fallen at least twice in the last year.
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My mental state score is below 24.
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I have lymphedema or restrictions on where IVs can be placed.
Select...
I have had or am getting knee replacement surgery on both sides or other lower body joint replacement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks and 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quadricep Muscle Strength
Thigh muscle volume
Thigh muscles composition
Secondary study objectives
30-second chair stand test
6-minute Walk Test
Health Related Quality of Life (RAND-36)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Preoperative ExercisesExperimental Treatment1 Intervention
Intervention is blood flow restriction training (BFRT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Flow Restriction Training (BFRT)
2020
N/A
~20

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
476 Previous Clinical Trials
92,955 Total Patients Enrolled
2 Trials studying Osteoarthritis
65 Patients Enrolled for Osteoarthritis
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,312 Total Patients Enrolled
33 Trials studying Osteoarthritis
10,686 Patients Enrolled for Osteoarthritis
Gustavo Almeida, PhDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
~0 spots leftby Dec 2024
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