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NCT Number: NCT07496554

Long-term Effects of Early Shoulder Exercise After CIED Implantation

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.

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Key information

Conditions

Cardiac Implantable Electronic Device (CIED) Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shoulder Dysfunction Shoulder Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzincan Binali Yildirim University, Faculty of Medicine

Erzincan, 24100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured Stretching and Strengthening Program

Behavioral

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.

Standard Post-Operative Care

Other

Standard clinical follow-up and verbal instructions regarding temporary activity restrictions (e.g., avoiding heavy lifting) without a structured exercise intervention.

Pendulum Exercise Protocol

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

Other outcomes

  1. Lead-related complications

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

Erzincan Binali Yildirim Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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