Long-term Effects of Early Shoulder Exercise After CIED Implantation

March 23, 2026 updated by: Muharrem Said Coşgun, Erzincan Binali Yildirim Universitesi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Erzincan
      • Erzincan, Erzincan, Turkey (Türkiye), 24100
        • Erzincan Binali Yildirim University, Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Patients undergoing first-time transvenous subcutaneous prepectoral CIED (Pacemaker, ICD, or CRT) implantation.
  • Patients with no prior history of major shoulder surgery or chronic shoulder pathology on the side of the implantation.
  • Patients who are capable of understanding and performing the prescribed exercise protocols.
  • Patients who provided written informed consent to participate in a 3-year longitudinal follow-up.

Exclusion Criteria:

  • Patients undergoing revision or replacement procedures of existing devices or leads.
  • Pre-existing frozen shoulder, rotator cuff tear, or severe adhesive capsulitis on the implantation side.
  • Neurological or musculoskeletal disorders affecting upper limb function (e.g., prior stroke sequelae or severe cervical disc herniation).
  • Cognitive impairment or psychiatric disorders preventing cooperation with the study protocol.
  • Lead-related complications (e.g., dislodgement or cardiac perforation) occurring within the first 2 weeks post-implantation, prior to the initiation of the exercise program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Group
atients received standard post-operative instructions with temporary activity restrictions (avoiding heavy lifting and excessive overhead reaching) for the first few weeks, but no structured exercise program.
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.
Experimental: Pendulum Exercise (PE) Group
Patients performed Codman's pendulum exercises starting 2 weeks post-implantation. The protocol included passive circular movements of the affected arm, performed twice daily for 6 weeks.
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.
Experimental: Stretching and Strengthening Exercise (SSE) Group
Patients followed a structured program involving active stretching and progressive resistance exercises for the shoulder girdle, starting 2 weeks post-implantation. Exercises were performed every other day for 6 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Range of Motion (ROM) - Flexion and Abduction
Time Frame: Baseline (pre-implantation), 2 weeks, 2 months, and 3 years post-implantation.
Measured in degrees using a universal goniometer. Active shoulder flexion and abduction were recorded to assess functional recovery of the shoulder joint on the side of the CIED implantation.
Baseline (pre-implantation), 2 weeks, 2 months, and 3 years post-implantation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand Grip Strength
Time Frame: Baseline, 2 weeks, 2 months, and 3 years post-implantation.
Measured in kilogram-force (kgf) using a Jamar hydraulic hand dynamometer. Three measurements were taken for the affected side, and the average value was recorded.
Baseline, 2 weeks, 2 months, and 3 years post-implantation.
QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Score
Time Frame: Baseline, 2 weeks, 2 months, and 3 years post-implantation.
A shortened version of the DASH questionnaire used to measure physical function and symptoms in patients with musculoskeletal disorders of the upper limb. Scores range from 0 (no disability) to 100 (most severe disability).
Baseline, 2 weeks, 2 months, and 3 years post-implantation.
hort Form-36 (SF-36) Health Survey
Time Frame: Baseline, 2 weeks, 2 months, and 3 years post-implantation.
A self-reported questionnaire measuring eight dimensions of health, including physical functioning and mental health. Scores for each domain range from 0 to 100, where higher scores represent better health status.
Baseline, 2 weeks, 2 months, and 3 years post-implantation.

Other Outcome Measures

Outcome Measure
Time Frame
Lead-related complications
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erzincan Binali Yildirim Universitesi

Investigators

  • Principal Investigator: Muharrem Said Cosgun, MD, Assoc. Prof., Erzincan Binali Yildirim University, Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

March 23, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 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 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-22/01 (Other Identifier: Erzincan Binali Yıldırım Üniversitesi Non-Interventional Clinical Research Ethics Committee)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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