The Effects of Preoperative Blood Flow Restriction Training in Patients Undergoing ACL Reconstruction

NCT06342063 | Completed

• 1 other identifier: 20-0070-E
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective feasibility study is designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial.

Conditions

ACL Injury; Sports Physical Therapy

Keywords

Blood Flow Restriction; Preconditioning; Rehab; ACL

Outcome Measures

Primary Outcomes (1)

• Biodex Strength Testing

  Quadriceps and Hamstring Muscle Strength and Endurance testing. Maximal peak torque (FT-LBS) was recorded for both knee flexion and extension at 60 degrees / second (indicative of strength) and 180 degrees / second (indicative of endurance).

  Baseline testing 1 day prior to physiotherapy initiation and Post intervention testing performed 1 day after physiotherapy completion but before ACL surgery.

Secondary Outcomes (2)

• Short Form Health Survey 12 (SF-12)

  Baseline testing 1 day prior to physiotherapy initiation and Post intervention testing performed 1 day after physiotherapy completion but before ACL surgery.

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline testing 1 day prior to physiotherapy initiation and Post intervention testing performed 1 day after physiotherapy completion but before ACL surgery.

Study Arms (2)

Physiotherapy with Blood Flow Restriction Group

ACTIVE COMPARATOR

This group underwent a physiotherapy protocol while using Blood Flow Restriction adjunctive therapy prior to ACL reconstruction.

Device: Blood Flow Restriction Therapy

Physiotherapy without Blood Flow Restriction Group

SHAM COMPARATOR

This group underwent a physiotherapy protocol without using Blood Flow Restriction adjunctive therapy prior to ACL reconstruction.

Device: Blood Flow Restriction Therapy Sham

Interventions

Blood Flow Restriction Therapy DEVICE

Patients wear a personalized tourniquet pressure system on their involved thigh while they perform a series of leg press machine exercises. This tourniquet is inflated.

Also known as: BFR

Physiotherapy with Blood Flow Restriction Group

Blood Flow Restriction Therapy Sham DEVICE

Patients wear a personalized tourniquet pressure system on their involved thigh while they perform a series of leg press machine exercises. This tourniquet is not inflated.

Also known as: Sham BFR Comparison Group

Physiotherapy without Blood Flow Restriction Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sagittal Knee instability caused by ACL tear requiring surgical reconstruction
• Minimum 4 weeks since the time of injury
• Age 18 to 50 years
• Range of motion required
• ▪ Active extension deficit \<5o, Active flexion \> 120o
• No previous surgery to affected knee

You may not qualify if:

• Functional impairment (neuro disease, gait abnormality, ambulatory aids at baseline)
• Severe spine or lower limb injuries
• Comorbidities including cardiovascular, respiratory or metabolic disease, blood coagulation disorders, current smoker

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

• Wengle L, Migliorini F, Leroux T, Chahal J, Theodoropoulos J, Betsch M. The Effects of Blood Flow Restriction in Patients Undergoing Knee Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Aug;50(10):2824-2833. doi: 10.1177/03635465211027296. Epub 2021 Aug 18.

  PMID: 34406084 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• John Theodoropoulos, MD, FRCSC

  Dovigi Sports Medicine Clinic, Mount Sinai Hospital, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measurement was blinded to participant intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were recruited and randomized to one of the two treatment arms.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 2, 2024
• Study Start: April 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: January 31, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)