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Behavioural Intervention

Blood Flow Restriction Training for Knee Instability (BRAINS Trial)

N/A
Recruiting
Research Sponsored by Caitin Conley
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Skeletally mature with closed growth plates visualized by radiograph
Age 14 to 40 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

BRAINS Trial Summary

This trial will study whether blood flow restriction training can improve knee instability.

Who is the study for?
This trial is for individuals aged 14-40 with closed growth plates and traumatic patellar instability, who are active in sports like tennis or skiing at least once a week. They must want to return to their pre-injury activity level. Excluded are those with certain knee conditions, surgeries, high BMI (>35), varicose veins, history of deep vein thrombosis in the family, planned long absences during the trial period, diabetes or uncontrolled hypertension.Check my eligibility
What is being tested?
The study tests blood flow restriction training (BFRT) against sham BFRT to see if it helps recovery from patellar instability. Participants will be randomly assigned to either real BFRT or a placebo-like version without actual restriction to compare outcomes.See study design
What are the potential side effects?
Potential side effects may include discomfort due to restricted blood flow during training sessions and possible muscle fatigue post-training. There might also be risks associated with wearing the device used for restricting blood flow.

BRAINS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My bones have finished growing, as confirmed by an X-ray.
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I am between 14 and 40 years old.

BRAINS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
MRI Muscle Volume
MRI T1rho
Quadriceps Strength Symmetry
+1 more

BRAINS Trial Design

2Treatment groups
Active Control
Group I: Standard Physical Therapy with Sham BFRTActive Control1 Intervention
Participants will undergo 8 weeks of sham blood flow restriction training with cuff inflated to less than 10% occlusion.
Group II: Standard Physical Therapy with BFRTActive Control1 Intervention
Participants will undergo 8 weeks of blood flow restriction training with cuff inflated to 60% occlusion.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Blood Flow Restriction Training (BFRT) enhances muscle strength and recovery by restricting blood flow to muscles during exercise, creating a hypoxic environment that increases muscle fiber recruitment and metabolic stress. This leads to greater muscle hypertrophy and strength gains, and stimulates the release of growth factors and anabolic hormones, promoting muscle repair and growth. For leg injury patients, BFRT allows effective muscle strengthening and rehabilitation with lower exercise intensities, reducing the risk of further injury while achieving significant therapeutic benefits.

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Who is running the clinical trial?

Caitin ConleyLead Sponsor
Cale Jacobs, PhDLead Sponsor
4 Previous Clinical Trials
60 Total Patients Enrolled
Caitlin ConleyLead Sponsor

Media Library

Leg Injury Research Study Groups: Standard Physical Therapy with Sham BFRT, Standard Physical Therapy with BFRT
~15 spots leftby Jun 2025
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