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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rehabilitation guidance | Experimental | 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. |
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| regular postoperative guidance | Active Comparator | regular postoperative guidance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a systematic rehabilitation exercise program (rehabilitation exercise routine) | Behavioral | a systematic rehabilitation exercise program (rehabilitation exercise routine) |
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| 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) |
| 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) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziqing Yu, PhD | Contact | 64041990 | yu.ziqing@zs-hospital.sh.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
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| regular guidance | Other | regular guidance |
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| 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) |