CIED Postoperative Upper Limb Stiffness and DisabilityNCT07494825

CIED Post-OR Rehabilitation

A study testing a systematic rehabilitation exercise program (rehabilitation exercise routine) and regular guidance in people with CIED Postoperative Upper Limb Stiffness and Disability, run by Shanghai Zhongshan Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: CIED Postoperative Upper Limb Stiffness and Disability
What is being tested?: a systematic rehabilitation exercise program (rehabilitation exercise routine) and regular guidance
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: No sites listed yet
Study dates: 1 Apr 2026to 31 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ziqing Yu, PhD contact

64041990

yu.ziqing@zs-hospital.sh.cn

About this study

Official title: 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.

Conditions: CIED Postoperative Upper Limb Stiffness and Disability
Being tested: a systematic rehabilitation exercise program (rehabilitation exercise routine), regular guidance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

a systematic rehabilitation exercise program (rehabilitation exercise routine)Behavioural
a systematic rehabilitation exercise program (rehabilitation exercise routine)
regular guidanceOther
regular guidance

Study groups in NCT07494825
Study group	Role	What they receive
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. Receives: Behavioral: a systematic rehabilitation exercise program (rehabilitation exercise routine)
regular postoperative guidance	Active comparator	regular postoperative guidance Receives: Other: regular guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202631 Dec 2026

First posted27 Mar 2026
Study start1 Apr 2026 (estimated)
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CIED Postoperative Upper Limb Stiffness and DisabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07494825
Sponsor's protocol ID: CIEDrehabilitation2025
Status last verified: Mar 2026
First submitted: 15 Mar 2026
Last updated: 27 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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 at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Construction of a Postoperative Upper Limb Rehabilitation Exercise System With Transvenous Leads for CIED Implantation and Its Safety and Effectiveness Verification
ClinicalTrials.gov ID: NCT07494825
Acronym / sponsor ID: CIEDrehabilitation2025
Conditions: CIED Postoperative Upper Limb Stiffness and Disability
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 600 participants (estimated)
Lead sponsor: Shanghai Zhongshan HospitalUniversity, hospital or other
Study start: 1 Apr 2026 (estimated)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 27 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
rehabilitation guidance	Experimental	Behavioral: a systematic rehabilitation exercise program (rehabilitation exercise routine)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.
regular postoperative guidance	Active comparator	Other: regular guidanceregular postoperative guidance

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
a systematic rehabilitation exercise program (rehabilitation exercise routine)a systematic rehabilitation exercise program (rehabilitation exercise routine)	Behavioural	rehabilitation guidance
regular guidanceregular guidance	Other	regular postoperative guidance

Primary outcome

Change in shoulder joint range of motion of the implanted upper limb after rehabilitation exercise intervention
Time frame: 3-month follow-up (compared with baseline preoperative data)
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)
Major safety endpoint - Composite of severe rehabilitation-related complications
Time frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)
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)

4 secondary outcomes

Change in upper limb functional ability of the implanted upper limb
Time frame: 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
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)
Change in quality of life
Time frame: 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
Time frame: Through 12-month follow-up (from postoperative day 1 to 12-month follow-up)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Background1. 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 dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Ziqing Yu, PhD contact

64041990

yu.ziqing@zs-hospital.sh.cn

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ziqing Yu, PhD (64041990, yu.ziqing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in shoulder joint range of motion of the implanted upper limb after rehabilitation exercise intervention (time frame: 3-month follow-up (compared with baseline preoperative data)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07494825, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.