Long-term Effects of Early Shoulder Exercise After CIED Implantation

NCT07496554 | Completed

• 1 other identifier: 2025-22/01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Implantable Electronic Device (CIED); Shoulder Dysfunction

Keywords

Shoulder Pain; Muscle Strength; Range of Motion; Quality of Life; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Shoulder Range of Motion (ROM) - Flexion and Abduction

  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 Outcomes (3)

• Hand Grip Strength

  Baseline, 2 weeks, 2 months, and 3 years post-implantation.

• QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Score

  Baseline, 2 weeks, 2 months, and 3 years post-implantation.

• hort Form-36 (SF-36) Health Survey

  Baseline, 2 weeks, 2 months, and 3 years post-implantation.

Other Outcomes (1)

• Lead-related complications

  Up to 3 years

Study Arms (3)

Control Group

OTHER

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

Pendulum Exercise (PE) Group

EXPERIMENTAL

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

Stretching and Strengthening Exercise (SSE) Group

EXPERIMENTAL

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

Interventions

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.

Stretching and Strengthening Exercise (SSE) Group

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.

Control Group

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.

Pendulum Exercise (PE) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erzincan Binali Yildirim Universitesi: lead

Study Sites (1)

Erzincan Binali Yildirim University, Faculty of Medicine

Erzincan, Erzincan, 24100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain; Postoperative Complications

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Muharrem Said Cosgun, MD, Assoc. Prof.

  Erzincan Binali Yildirim University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: February 1, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 23, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

TU (1)