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Not yet recruitingNCT07494825Updated Mar 27, 2026

CIED Post-OR Rehabilitation

An interventional study of a systematic rehabilitation exercise program (rehabilitation exercise routine) and regular guidance in CIED Postoperative Upper Limb Stiffness and Disability, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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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Conditions studied

  • CIED Postoperative Upper Limb Stiffness and Disability
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In context

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • 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)

  • Active comparator
    regular postoperative guidance

    regular postoperative guidance

    Other: regular guidance

Interventions

  • Behaviorala systematic rehabilitation exercise program (rehabilitation exercise routine)

    a systematic rehabilitation exercise program (rehabilitation exercise routine)

  • Otherregular guidance

    regular guidance

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3-month follow-up (compared with baseline preoperative data)

  2. 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)

    Time frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)

Secondary outcomes

  1. 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)

    Time frame: 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)

  2. 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)

    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)

  3. 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)

    Time frame: 1-month, 3-month, 6-month, 9-month, and 12-month follow-up (each compared with baseline preoperative data)

  4. 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)

    Time frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)

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Study locations

No study locations are listed for this record.

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References and documents

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

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07494825
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Yixiu Liang (doctor, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Mar 27, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 27, 2026

Study contacts

Ziqing Yu, PhD
Contact
yu.ziqing@zs-hospital.sh.cn
64041990

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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