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

NCT04492059 | Withdrawn

• 1 other identifier: BFR Achilles Tendon
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Blood flow restriction; physical therapy; Achilles tendon; Achilles tendon rupture; Achilles tendon repair

Outcome Measures

Primary Outcomes (1)

• Change in plantarflexion strength from baseline

  Plantarflexion strength to be measured via dynamometer

  Measured at six-week, three-month and six-month postoperative visits

Secondary Outcomes (7)

• Change in range of motion

  Measured at six-week, three-month and six-month postoperative visits

• Achilles Tendon Total Rupture Score

  Measured at initial visit, six-week, three-month and six-month postoperative visits

• Pain on the visual analog score

  Measured at initial visit, six-week, three-month and six-month postoperative visits

• PROMIS pain scores

  Measured at initial visit, six-week, three-month and six-month postoperative visits

• PROMIS function scores

  Measured at initial visit, six-week, three-month and six-month postoperative visits

Study Arms (2)

Blood flow restriction augmented physical therapy

EXPERIMENTAL

The group will undergo traditional physical therapy with the augment of blood flow restriction therapy under the supervision of trained physical therapists.

Device: Blood flow restriction augmented physical therapy

Traditional physical therapy

ACTIVE COMPARATOR

The group will undergo traditional physical therapy without the augment of blood flow restriction therapy under the supervision of trained physical therapists.

Other: Physical therapy

Interventions

Blood flow restriction augmented physical therapy DEVICE

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.

Blood flow restriction augmented physical therapy

Physical therapy OTHER

Completing traditional physical therapy.

Traditional physical therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18-65 who suffered an achilles tendon rupture.
• Patients with achilles tendon rupture that are being treated operatively and non-operatively.

You may not qualify if:

• undergoing a revision procedure
• other concomitant injuries of the same leg
• have a history of deep vein thrombosis
• peripheral vascular disease
• neurovascular injury to the extremity
• are unable to tolerate BFR treatment
• have a leg circumference greater than the largest available tourniquet circumference of 96.52 cm
• unable to complete physical therapy.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48226, United States

Location

Related Publications (9)

• Heikkinen J, Lantto I, Flinkkila T, Siira P, Laine V, Niinimaki J, Ohtonen P, Leppilahti J.

  BACKGROUND

• Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.

  PMID: 18466185 BACKGROUND

• Centner C, Lauber B, Seynnes OR, Jerger S, Sohnius T, Gollhofer A, Konig D. Low-load blood flow restriction training induces similar morphological and mechanical Achilles tendon adaptations compared with high-load resistance training. J Appl Physiol (1985). 2019 Dec 1;127(6):1660-1667. doi: 10.1152/japplphysiol.00602.2019. Epub 2019 Nov 14.

  PMID: 31725362 BACKGROUND

• Yow BG, Tennent DJ, Dowd TC, Loenneke JP, Owens JG. Blood Flow Restriction Training After Achilles Tendon Rupture. J Foot Ankle Surg. 2018 May-Jun;57(3):635-638. doi: 10.1053/j.jfas.2017.11.008. Epub 2018 Feb 21.

  PMID: 29477554 BACKGROUND

• Ladlow P, Coppack RJ, Dharm-Datta S, Conway D, Sellon E, Patterson SD, Bennett AN. Low-Load Resistance Training With Blood Flow Restriction Improves Clinical Outcomes in Musculoskeletal Rehabilitation: A Single-Blind Randomized Controlled Trial. Front Physiol. 2018 Sep 10;9:1269. doi: 10.3389/fphys.2018.01269. eCollection 2018.

  PMID: 30246795 BACKGROUND

• DePhillipo NN, Kennedy MI, Aman ZS, Bernhardson AS, O'Brien L, LaPrade RF. Blood Flow Restriction Therapy After Knee Surgery: Indications, Safety Considerations, and Postoperative Protocol. Arthrosc Tech. 2018 Sep 24;7(10):e1037-e1043. doi: 10.1016/j.eats.2018.06.010. eCollection 2018 Oct.

  PMID: 30377584 BACKGROUND

• Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.

  PMID: 19952261 BACKGROUND

• Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11.

  PMID: 21917016 BACKGROUND

• Madarame H, Sasaki K, Ishii N. Endocrine responses to upper- and lower-limb resistance exercises with blood flow restriction. Acta Physiol Hung. 2010 Jun;97(2):192-200. doi: 10.1556/APhysiol.97.2010.2.5.

  PMID: 20511128 BACKGROUND

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Erickson Andrews, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be assigned to the blood flow restriction augmented physical therapy group following surgery or will undergo the usual physical therapy. Various measurements will be taken at follow up appointments as well as patient reported outcomes and compared between the two groups.

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: July 30, 2020
• Study Start: September 1, 2020
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)