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

What this Trial Is About

Researchers are evaluating whether reducing arm movement restrictions after cardiac implantable electronic device (CIED) surgery can improve patient experience and reduce complications. This trial compares lenient versus strict arm restrictions, addressing the current lack of standardized postoperative guidelines and varied advice given to patients. The study aims to create more uniform recommendations across hospitals to enhance quality of life and reduce anxiety without compromising safety. Participants are randomly assigned to either a strict or lenient arm restriction group. The strict group follows current institutional protocols including no arm movement for 24 hours, no overhead arm movement for 8 weeks, and limitations on lifting and sports activities for 8 weeks. The lenient group has fewer restrictions, limiting only shoveling for 7 days and golf, swimming, or tennis for 14 days, with no other limitations. These instructions are delivered through printed discharge summaries, electronic health records, and interactive voice reminders, with the study switching between the two restriction types every 8 months. During the study, patients receive standard follow-up care through a device clinic and 24/7 nursing support. Researchers monitor complications such as lead dislodgement, frozen shoulder, venous thrombosis, and significant hematoma formation over one year. The trial assesses both safety and patient quality of life by tracking these outcomes, supported by regular communication and education to ensure adherence to assigned restrictions. Total participation duration aligns with surgery recovery and follow-up periods.

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