Clinical trial NCT06775691: Comparison of Upper Extremity Function, Physical Activity Levels and Peripheral Muscle Strength, Fear of Movement, Balance, Activities of Daily Living and Quality of Life in Patients With Pacemakers According to Pacemaker Type
Official title: Comparison of Upper Extremity Function, Physical Activity Levels and Peripheral Muscle Strength, Fear of Movement, Balance, Activities of Daily Living and Quality of Life in Patients With Pacemakers According to Pacemaker Type
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pacemaker
Implantable Cardioverter Defibrillator
Cardiac Resynchronization Therapy
Lead sponsor: Erol Olcok Corum Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2025-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who regularly visit for pacemaker check-ups will be invited to participate in the study.

Brief summary: While research and clinical practice have demonstrated the objective benefits of pacemaker use on mortality, morbidity, and quality of life, some patients do not experience the expected level of improvement following device implantation. The purpose of this research was to determine the effects of device implantation on daily living activities, upper extremity functions, peripheral muscle strength, balance problems, fear of movement and quality of life.


Eligibility criteria: Inclusion Criteria:

* At least 3 months have passed since pacemaker implantation and there are no complications in the last pacemaker control,
* Being in NYHA class I-II-III,
* Patients with no coordination problems,
* Volunteering to participate in the research

Exclusion Criteria:

* Patients with a history of shoulder pathologies prior to pacemaker implantation that may restrict movement of the upper limb (conditions such as severe pain around the shoulder, edema or shoulder dislocation that may restrict upper limb movement),
* Patients with a history of shoulder surgery (limitation in range of motion),
* Patients who have had a cerebrovascular event resulting in mastectomy or arm involvement on the affected side,
* Patients with decompensated heart failure,
* Patients with a history of ICD inappropriate shock,
* Those with acute myocardial infarction,
* Patients with malignancy on active treatment, patients with collagen tissue disease receiving systemic steroids,
* Chronic kidney disease patients on dialysis with unstable volume load

Primary outcomes:
measure: Evaluation of upper extremity functional capacity
timeFrame: 1 years
measure: Evaluation of peripheral muscle strength
timeFrame: 1 years
measure: Evaluation of balance
timeFrame: 1 years
measure: Evaluation of fear of movement
timeFrame: 1 years
measure: Evaluation of physical activity levels
timeFrame: 1 years
measure: Evaluation of activities of daily living
timeFrame: 1 years
measure: Evaluation of quality of life
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hitit University Corum Erol Olçok Training and Research Hospital
state: Center
Study officials:
References: