Randomized Study Comparing Lenient and Strict Arm Movement Guidelines After Cardiac Device Surgery to Improve Recovery and Reduce Complications

What this Trial Is About

Researchers are evaluating whether reducing arm movement restrictions after receiving Cardiac Implantable Electronic Devices CIED improves patient experience and lowers complication rates. This trial compares lenient versus strict arm restrictions following device surgery to develop standardized postoperative guidelines. The study uses a cluster crossover design to assess outcomes like lead dislodgement, device infection, hematoma, upper limb deep vein thrombosis, and frozen shoulder over one year. Participants are randomly assigned to receive either strict arm restrictions, which include no arm movement for 24 hours and no overhead arm movement or lifting heavier than 5 lbs for 8 weeks, or lenient restrictions that mainly limit shoveling and certain sports for shorter periods without overhead or weight limitations. Arm restriction instructions are delivered via nurses, printed summaries, electronic health records, and interactive voice reminders. The study cycles between these restriction protocols every 8 months. During the trial, patients receive standard follow-up through a device clinic and a 247 on-call nursing program. Researchers will monitor complications and patient quality of life using clinical assessments over one year. The primary outcome is a combination of lead dislodgement, frozen shoulder, upper arm venous thrombosis, and significant hematoma formation. Secondary outcomes include rates of hematoma, lead dislodgement, and frozen shoulder.

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