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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks and 16 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks and 16 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quadricep Muscle Strength

Thigh muscle volume

Thigh muscles composition

Secondary outcome measures

30-second chair stand test

6-minute Walk Test

Health Related Quality of Life (RAND-36)

+6 more

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

91,410 Total Patients Enrolled

2 Trials studying Osteoarthritis

65 Patients Enrolled for Osteoarthritis

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,865 Total Patients Enrolled

29 Trials studying Osteoarthritis

10,038 Patients Enrolled for Osteoarthritis

Gustavo Almeida, PhDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial actively searching for participants?

"Confirmed. Clinicaltrials.gov's records show that this medical research, which was publicly posted on September 23rd 2022, is presently recruiting patients. The investigation needs 20 people to be recruited from one centre of care."

Answered by AI

How many test subjects have been recruited for this experiment?

"Affirmative. According to records found on clinicaltrials.gov, this medical research project is currently searching for individuals who meet the criteria set forth in the study protocol. Originating from a posting date of September 23rd 2022 and last updated as recently as October 26th 2023, there are presently 20 vacancies at 1 trial locations."

Answered by AI

What are the core aims of this research endeavor?

"The core goal of this study, evaluated at Baseline, 8 weeks and 16 weeks is to assess thigh muscle composition. Additionally, the study examines Health Related Quality of Life (RAND-36), Real-time Physical Activity via activity monitor tracking daily steps taken, as well as Inflammatory Biomarkers including Interleukin (IL)-1β, IL-2, IL-5, IL-6 ,IL 10 ,IL 12p70 ,IL 13 and Interferon γ."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement

Gustavo Almeida 2022. "Blood Flow Restriction Training in Individuals Awaiting Total Knee Replacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06111690.

All > Knee Replacement