CIED Post-OR Rehabilitation

Construction of a Postoperative Upper Limb Rehabilitation Exercise System With Transvenous Leads for CIED Implantation and Its Safety and Effectiveness Verification

The purpose of this study is to develop a systematic rehabilitation exercise program (rehabilitation exercise routine), focusing on the rehabilitation training of the upper limb on the implantation side after transvenous cardiac implantable electronic devices (CIEDs) implantation, and to explore its impact on the joint function of the implanted upper limb and the overall quality of life of patients. This study will conduct long-term follow-up by comprehensively using imaging examinations and relevant professional assessment scales, focusing on evaluating the clinical safety of this rehabilitation exercise routine, and simultaneously clarifying its improvement effect on discomfort symptoms (such as pain, stiffness, etc.) and functional abnormalities of the implanted limb, so as to provide scientific basis and practical guidance for the standardized rehabilitation of patients after transvenous CIEDs implantation.

Study Overview

• Status: Not yet recruiting
• Conditions: CIED Postoperative Upper Limb Stiffness and Disability
• Intervention / Treatment: Behavioral: a systematic rehabilitation exercise program (rehabilitation exercise routine); Other: regular guidance

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ziqing yu, PhD; Phone Number: 64041990; Email: yu.ziqing@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Patients who meet the indications for transvenous CIEDs implantation in accordance with ACC/AHA/HRS or ESC guidelines, including single-chamber, dual-chamber, and triple-chamber pacemakers;
• Patients who have previously implanted a transvenous pacemaker and plan to upgrade the pacemaker requiring the addition of electrode leads;
• Patients aged > 18 years at the time of enrollment;
• The subject (or the patient's legal authorized representative) is willing and able to sign their name and date on the patient informed consent form.

Exclusion Criteria

• Subjects aged ≤ 18 years old, pregnant women or lactating patients;
• Patients with disease conditions that the researcher deems inappropriate for participation in this study;
• Patients who have previously implanted a transvenous pacemaker and only need to replace the pulse generator;
• Patients who are simultaneously participating in other clinical studies related to cardiac electronic implantable devices.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rehabilitation guidance; systematic rehabilitation exercise program (rehabilitation exercise routine), focusing on the rehabilitation training of the upper limb on the implantation side after transvenous cardiac implantable electronic devices (CIEDs) implantation, and to explore its impact on the joint function of the implanted upper limb and the overall quality of life of patients.	Behavioral: a systematic rehabilitation exercise program (rehabilitation exercise routine); a systematic rehabilitation exercise program (rehabilitation exercise routine)
Active Comparator: regular postoperative guidance	Other: regular guidance; regular guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in shoulder joint range of motion of the implanted upper limb after rehabilitation exercise intervention	Outcome Measure: Change in shoulder joint range of motion of the implanted upper limb after rehabilitation exercise intervention Unit of Measure: Degrees (°) (difference between follow-up and baseline) Time Frame: 3-month follow-up (compared with baseline preoperative data)	3-month follow-up (compared with baseline preoperative data)
Major safety endpoint - Composite of severe rehabilitation-related complications	Description: Severe complications related to rehabilitation exercise, including lead dislodgement caused by improper exercise, severe muscle strain, and joint dislocation of the implanted upper limb Unit of Measure: Percentage (%) Time Frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)	Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in upper limb functional ability of the implanted upper limb	Assessment Tool: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) Scale Details: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); minimum score = 0, maximum score = 100; higher scores indicate worse upper limb function Unit of Measure: Score (0-100) (difference between follow-up and baseline) Time Frame:1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)	1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)
Change in pain level of the implanted upper limb	Assessment Tool: Visual Analog Scale (VAS) Scale Details: Visual Analog Scale (VAS); minimum score = 0 (no pain), maximum score = 10 (severe pain); higher scores indicate more severe pain Unit of Measure: Score (0-10) (difference between follow-up and baseline) Time Frame: Immediate postoperative (within 24 hours), 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)	Immediate postoperative (within 24 hours), 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)
Change in quality of life	Assessment Tool: 36-Item Short Form Health Survey (SF-36) Scale Details: 36-Item Short Form Health Survey (SF-36); each domain score ranges from 0 to 100, total score ranges from 0 to 100; higher scores indicate better quality of life Unit of Measure: Score (0-100) (difference between follow-up and baseline) Time Frame: 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)	1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)
Minor safety endpoint - Incidence of rehabilitation-related adverse events	Minor adverse events related to rehabilitation exercise, including mild muscle soreness, local discomfort at the implantation site during exercise, and transient fatigue Unit of Measure: Percentage (%) Time Frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)	Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• 1. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009--a World Society of Arrhythmia's project. Pacing Clin Electrophysiol. 2011;34(8):1013-27. 2. Burri H, Starck C, Auricchio A, Biffi M, Burri M, D'Avila A, et al. EHRA expert consensus statement and practical guide on optimal implantation technique for conventional pacemakers and implantable cardioverter-defibrillators: endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin-American Heart Rhythm Society (LAHRS). Europace. 2021;23(7):983-1008. 3. Daniels JD, Sun S, Zafereo J, Minhajuddin A, Nguyen C, Obel O, et al. Preventing shoulder pain after cardiac rhythm management device implantation: a randomized, controlled study. Pacing Clin Electrophysiol. 2011;34(6):672-8. 4. Cook KF, Roddey TS, Olson SL, Gartsman GM, Valenzuela FF, Hanten WP. Reliability by surgical status of self-reported outcomes in patients who have shoulder pathologies. J Orthop Sports Phys Ther. 2002;32(7):336-46. 5. Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11(6):587-94. 6. Beaton DE, Richards RR. Measuring function of the shoulder. A cross-sectional comparison of five questionnaires. J Bone Joint Surg Am. 1996;78(6):882-90. 7. Hollinshead RM, Mohtadi NG, Vande Guchte RA, Wadey VM. Two 6-year follow-up studies of large and massive rotator cuff tears: comparison of outcome measures. J Shoulder Elbow Surg. 2000;9(5):373-81. 8. Razmjou H, Bean A, van Osnabrugge V, MacDermid JC, Holtby R. Cross-sectional and longitudinal construct validity of two rotator cuff disease-specific outcome measures. BMC Musculoskelet Disord. 2006;7:26. 9. Wongcharoen W, Petvipusit W, Prasertwitayakij N, Gunaparn S, Meemajam S, Pisespongsa C, et al. Effect of early pendulum exercise o

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 15, 2026
• First Submitted That Met QC Criteria: March 21, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CIEDrehabilitation2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No