A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery

NCT04915261 | Recruiting Phase 4

• 1 other identifier: 20210168-01H
• Study Type: interventional
• Target: 6,300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post operatively and reduce complication rates. There are multiple and varied arm restriction instructions given to patients receiving CIED's with limited universally accepted protocols or advice on restrictions for patients following surgery. Restrictions such as arm immobilization, showering and weight lifting, in addition to contradictory advice between various hospitals and physicians, can negatively affect patient quality of life and increase patient anxiety with no current evidence for benefit. A cluster cross over randomized trial has been designed to test the comparative effectiveness of lenient vs strict arm restrictions for all patients receiving implantable devices. Instructions within both arms of this study are considered within reasonable practice in Canada. All arm restriction instructions and parameters will be embedded within EPIC, nurses will teach the restriction in addition they will be provide to the patients via printed EPIC discharge summaries. Further links will be embedded in the After Visit Summary (AFS) printouts and my Chart for patients in EPIC. These instructions will be changed every 8 months, as per the crossover design of the trial. Additionally, both arms will utilize interactive voice recognition (IVR) to provide patients with further reminders and instruction on arm restrictions. All patients are given standard of care instructions for follow up and complication assessment through the investigators' device clinic and 24/7 on call nursing program.

Conditions

Post-Op Complication

Keywords

Cardiac; Implantable; Electronic; Device; Arm; Restriction; Post-operative; infection; dislodgement; hematoma; DVT

Outcome Measures

Primary Outcomes (1)

• A composite of 1) Lead dislodgement 2) Frozen shoulder 3) Upper arm venous thrombosis 4) Clinically significant hematoma formation

  Definitions of each component of primary outcome: 1. Lead dislodgement; dislodgment requiring surgical repair and dislodgement not occurring in the immediate post-op period (i.e., before the randomized intervention begins). Immediate post-op period is defined as from pocket closure to dislodgement suspected on first post- operative CXR (which is done 2-4hrs post-op). 2. Frozen shoulder in this study is defined as: Nursing or physician note mention of chronologically related (to index surgery) patient complaint of new or markedly worsened shoulder pain and/or restricted and stiffness of active and passive range of motion. 3. Upper arm venous thrombosis. 4. Clinically significant hematoma is defined as done in BRUISE CONTROL 2 trial: a hematoma that required re-operation and/or resulted in prolongation of hospitalization and/or required interruption of oral anticoagulation.

  1 year

Secondary Outcomes (3)

• Rate of hematoma

  1 year

• Rate of lead dislodgement

  1 year

• Rate of frozen shoulder

  1 year

Study Arms (2)

Strict Arm

ACTIVE COMPARATOR

The strict arm group will be given the following restrictions. These restrictions are the current institutional protocol at the study site and falls within common practice pattern across Canada: 1. No arm or shoulder movement x 24 hours 2. No movement of affected arm overhead x 8 weeks 3. No lifting anything heavier than 5 lbs (2.5kg) and avoid any kind of sports or other vigorous activities including golf, tennis, swimming or sweeping x 8 weeks 4. Avoid any kind of shovelling x 8 weeks

Behavioral: Strict Arm Restriction

Lenient Arm

ACTIVE COMPARATOR

The lenient arm restriction group will be given the following restrictions. The justification for the selected lenient restriction is based on the current recommendations at a Canadian center as identified by the national survey: 1. No shoveling 7 days, 2. No golfing/swimming/tennis 14 days 3. No other restrictions (overhead activity and weight lifting no limitation)

Behavioral: Lenient Arm Restriction

Interventions

Lenient Arm Restriction BEHAVIORAL

The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.

Lenient Arm

Strict Arm Restriction BEHAVIORAL

The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.

Strict Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients undergoing device surgery which includes implantation of at least one new endovascular lead

You may not qualify if:

• Standalone CIED generator replacement
• Subcutaneous implantable cardioverter defibrillators
• Leadless endocardial pacemakers
• Temporary permanent pacemakers

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Related Publications (1)

• Golian M, Sadek MM, Aydin A, Davis D, Green M, Klein A, Nair GM, Nery P, Ramirez FD, Redpath C, Hansom SP, Wells GA, Birnie DH. A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT). Am Heart J. 2023 May;259:52-57. doi: 10.1016/j.ahj.2023.01.016. Epub 2023 Jan 25.

  PMID: 36708911 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Infections; Hematoma

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Study Officials

• David Birnie

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tammy Knight

CONTACT

613.696.7000; tknight@ottawaheart.ca

Mehrdad Golian

CONTACT

613.696.7271; mgolian@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief, Division of Cardiology, University of Ottawa Heart Institute

Model Details: The trial is a single centre non-inferiority cluster crossover trial. Arm restriction protocol will cross over every 8 months with a one month run-in then 7 months of data collection.

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 7, 2021
• Study Start: August 19, 2021
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)