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Use of Blood Flow Restriction Therapy in Perioperative Rehabilitation Following Achilles Tendon Rupture

NCT04492059 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-02

No results posted yet for this study

Summary

The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy in the rehabilitation of Achilles tendon rupture (ATR). Muscle atrophy occurs following Achilles tendon rupture, whether managed non operatively or operatively, which has implications on patient outcomes. The goal of physical therapy in the perioperative period is to regain and ultimately return to activity. BFR has been proposed to reduce atrophy and maintain strength, which would theoretically mitigate the deconditioning effects of an injury on surrounding musculature. BFR is proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia and induction of growth cytokines, thus leading to muscle hypertrophy.

The goal of this investigation is to determine if using BFR as an adjunct in physical therapy following ATR would reduce muscular atrophy and lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR accelerates the rehabilitation process and allows patients to perform standard rehabilitative functional tests and return to play sooner. Furthermore, the investigators will investigate patient reported outcomes metrics.

The investigators hypothesize that the BFR group will have significantly greater strength gains at all time points in both non operatively and operatively treated ATR. Previous studies have shown that BFR has potential in increasing Achilles tendon stiffness, tendon cross-sectional area, muscle strength and muscle hypertrophy. However, there is a lack of evidence regarding the use of BFR in both the pre and postoperative period specifically relating to ATR. The investigators believe that the use of BFR in the perioperative period surrounding an Achilles tendon rupture and ATR has the potential to significantly decreased muscle atrophy, improve patient satisfaction and lead to earlier return to sport.

Conditions

  • Achilles Tendon Rupture
  • Achilles Tendon Surgery

Interventions

DEVICE

Blood flow restriction augmented physical therapy

Using a blood flow restriction cuff during physical therapy. It is a pressurized cuff that is used to decrease the amount of oxygen that is available to the muscle during exercise. This stimulates the muscle to believe it is in an anoxic state and can produce greater strength and hypertrophy with fewer reps and less weight which would mean less stress on a surgically repaired tendon.

OTHER

Physical therapy

Completing traditional physical therapy.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Erickson Andrews, MD · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-03-25
Completion
2022-03-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04492059 on ClinicalTrials.gov