NCT07496554

Long-term Effects of Early Shoulder Exercise After CIED Implantation

Effects of Early Shoulder Exercise on Functional Recovery After CIED Implantation: A 3-Year Randomized Cohort Follow-Up

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Erzincan Binali Yildirim Universitesi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Shoulder dysfunction frequently occurs after cardiac implantable electronic device (CIED) implantation, adversely affecting quality of life. While early postoperative exercise is known to be effective in the short term, data on long-term durability is limited. This 3-year longitudinal follow-up study evaluates the sustained benefits of pendulum exercises (PE) and stretching \& strengthening exercises (SSE) compared to standard care. We assessed shoulder range of motion, grip strength, and quality of life to determine if early mobilization provides lasting functional recovery without compromising lead safety.

Detailed description

This study is a 3-year follow-up of a randomized controlled trial involving patients who underwent transvenous subcutaneous prepectoral CIED implantation. Participants were originally randomized into three groups: * Control group (standard care), * Pendulum Exercise (PE) group, * Stretching and Strengthening Exercise (SSE) group. The exercise protocols were initiated 2 weeks post-implantation and continued for 6 weeks. In this longitudinal phase, patients were re-evaluated at a 3-year follow-up mark. Functional outcomes were measured using grip strength (kilogram-force), shoulder range of motion (flexion and abduction degrees), Visual Analog Scale (VAS) for pain, QuickDASH for functional disability, and the SF-36 survey for quality of life. Long-term safety was also monitored by assessing lead-related complications (dislodgement or fracture) over the 3-year period.

Conditions

• Cardiac Implantable Electronic Device (CIED)
• Shoulder Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	Structured Stretching and Strengthening Program	A structured exercise program initiated 2 weeks post-implantation, focusing on active stretching and progressive resistance exercises for the shoulder girdle muscles. The protocol was performed every other day for a total of 6 weeks.
OTHER	Standard Post-operative Care	Standard clinical follow-up and verbal instructions regarding temporary activity restrictions (e.g., avoiding heavy lifting) without a structured exercise intervention.
BEHAVIORAL	Pendulum Exercise Protocol	Participants performed Codman's pendulum exercises starting 2 weeks after CIED implantation. The protocol involved passive, gravity-assisted circular and linear movements of the affected arm. Exercises were performed twice daily for a duration of 6 weeks.

Timeline

• Start date: 2021-02-01
• Primary completion: 2026-03-01
• Completion: 2026-03-23
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Turkey (Türkiye)