Cardiac Implantable Electronic Device (CIED), Shoulder Dysfunction
Conditions
Keywords
Shoulder Pain, Muscle Strength, Range of Motion, Quality of Life, Postoperative Complications
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.
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.
Interventions
BEHAVIORALStructured 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.
Standard clinical follow-up and verbal instructions regarding temporary activity restrictions (e.g., avoiding heavy lifting) without a structured exercise intervention.
BEHAVIORALPendulum 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.
Sponsors
Erzincan Binali Yildirim Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Range of Motion (ROM) - Flexion and Abduction | 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
| Measure | Time frame | Description |
|---|---|---|
| Hand Grip Strength | 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. |
| QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Score | 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). |
| hort Form-36 (SF-36) Health Survey | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMuharrem Said Cosgun, MD, Assoc. Prof.
Erzincan Binali Yildirim University, Faculty of Medicine
Outcome results
None listed