Physical Impairments in Premature Ventricular Complex

Investigation of Respiratory Functions, Muscle Strength, Physical Activity Level, and Quality of Life in Individuals With Premature Ventricular Complexes

Premature ventricular complexes may be observed in individuals without underlying disease due to factors such as physical inactivity, advanced age, smoking, male sex, and psychosocial disturbances, and in some cases may result in sudden cardiac death. Therefore, the aim of this study is to investigate respiratory function, respiratory muscle strength, cough strength, handgrip strength, physical activity level, and quality of life in individuals with premature ventricular complexes.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Ventricular Complexes
• Intervention / Treatment: Other: Physical Evaluations of Patients with Premature Ventricular Complex; Other: Physical Evaluations of Healthy Individuals

Detailed Description

The primary aim of this study is to comprehensively investigate respiratory function, respiratory muscle strength, cough strength, handgrip strength, physical activity level, and quality of life in individuals with premature ventricular complexes. Additionally, an important secondary aim is to identify potential differences in these parameters between individuals with premature ventricular complexes and healthy controls and to contribute original findings to the existing literature.Participants will be evaluated in terms of these parameters through clinical assessments, questionnaires, and measurements.

• Study Type: Observational
• Enrollment (Estimated): 52

Contacts and Locations

• Study Contact: Name: GÜLŞAH BARĞI; Phone Number: +90 232 299 0739; Email: gulsahbargi35@gmail.com
• Study Contact Backup: Name: ESRA SUDE AKIN; Phone Number: +90 232 299 0739

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye), 35140
    • Izmir Democracy University
    • Contact: GÜLŞAH BARĞI; Phone Number: 0232 299 0739
    • Contact: ESRA SUDE AKIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adults including individuals diagnosed with symptomatic premature ventricular complexes and healthy control participants. Participants will be recruited from patients presenting to the Cardiology Department of Buca Seyfi Demirsoy Training and Research Hospital and volunteers without premature ventricular complexes.

Description

Inclusion Criteria for Individuals with Premature Ventricular Complexes (PVCs):

• Aged between 18 and 80 years
• Presence of symptomatic premature ventricular complexes resistant to ≥1 antiarrhythmic medication (including β-blockers and calcium channel blockers)
• Premature ventricular complex burden ≥10%
• Ventricular arrhythmias originating from any focus within the right or left ventricle
• Physically able to participate in all study assessments
• Willingness to participate in the study by providing written informed consent

Inclusion Criteria for Control Group Participants:

• Aged between 18 and 80 years
• Healthy individuals
• Willingness to participate in the study
• Physically able to participate in all study assessments

Exclusion Criteria for Individuals with Premature Ventricular Complexes (PVCs):

• Left ventricular ejection fraction (LVEF) <45% unless PVC-induced cardiomyopathy is documented (defined as a >15% improvement in LVEF following reduction of PVC burden through pharmacological therapy or ablation)
• Progressive decline in LVEF within the last 4 months, regardless of etiology
• Severe heart failure classified as New York Heart Association (NYHA) Class ≥III
• Ventricular arrhythmias attributed to underlying structural heart disease, known myocardial scar, or myocarditis
• Change in the dosage of antiarrhythmic medications (including β-blockers and calcium channel blockers) within 2 months prior to enrollment
• Failed catheter ablation within 3 months prior to enrollment
• Known thyroid disorders or individuals undergoing renal dialysis
• Life expectancy <12 months
• Presence of angina pectoris
• Diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
• Resting heart rate >120 beats/min
• Resting systolic blood pressure ≥180 mmHg
• Resting diastolic blood pressure ≥100 mmHg
• Resting peripheral oxygen saturation ≤90%

Exclusion Criteria for Control Group Participants:

• Presence of premature ventricular complexes
• Presence of any acute or chronic medical condition

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ventricular premature complexes group; This group will consist of individuals with premature ventricular complex.	Other: Physical Evaluations of Patients with Premature Ventricular Complex; In this study, data from individuals with premature ventricular complex will be collected through face-to-face assessments. Respiratory functions, respiratory and peripheral muscle strength, cough strength, physical activity level, and quality of life will be assessed in these individuals who meet the inclusion criteria. All data obtained through these assessments will be collected from participants face-to-face at one time and for a maximum of approximately 1 hour.
Control Group; This group will consist of healthy individuals.	Other: Physical Evaluations of Healthy Individuals; In this study, data from healthy individuals will be collected through face-to-face assessments. Respiratory functions, respiratory and peripheral muscle strength, cough strength, physical activity level, and quality of life will be assessed in these individuals who meet the inclusion criteria.All data obtained through these assessments will be collected from participants face-to-face at one time and for a maximum of approximately 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal inspiratory pressure (MIP)	The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal expiratory pressure (MEP)	The MEP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.	through study completion, an average of 1 year
Forced vital capacity (FVC)	Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer.	through study completion, an average of 1 year
Forced expiratory volume in the first second (FEV1)	Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.	through study completion, an average of 1 year
Peak flow rate (PEF)	Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.	through study completion, an average of 1 year
Cough Strength	Participants' peak cough expiratory flow (PCEF) values will be assessed in an upright sitting position using a peak cough flow meter (ExpiRite Peak Flow Meter, China). Following a deep inspiration, participants will be instructed to cough as forcefully as possible into the device. The best value obtained from at least three trials will be recorded.	through study completion, an average of 1 year
Handgrip Strength	Maximum isometric strength of the hand and forearm muscles will be measured using a hydraulic hand dynamometer.Measurements will be performed in an upright sitting position in accordance with guidelines. The mean of the three measurements for the right and left hands will be used for analysis.	through study completion, an average of 1 year
Assessment of Physical Activity	Participants' physical activity levels over the previous seven days will be assessed using the International Physical Activity Questionnaire-Short Form. The questionnaire consists of 7 items that assess time spent walking, and moderate- and vigorous-intensity physical activities over the last seven days. Total physical activity scores will be calculated by summing the duration (minutes) and frequency (days) of walking, moderate-intensity, and vigorous-intensity activities. Total physical activity score will be expressed as metabolic equivalent task minutes per week (MET-min/week).	through study completion, an average of 1 year
FEV1 / FVC	Pulmonary function (Forced expiratory volume in the first second/Forced vital capacity (FEV1 / FVC)) will be evaluated with a spirometer.	through study completion, an average of 1 year
Assessment of Quality of Life	Participants' quality of life will be evaluated using the Short Form-36 Health Survey (SF-36). The SF-36 assesses eight health domains: general health, physical functioning, role limitations due to physical problems, role limitations due to emotional problems, social functioning, bodily pain, vitality, and mental health, along with one additional item assessing health transition. Participants will be instructed to respond to each question in a manner that best reflects their current condition, and researchers will provide clarifying guidance when necessary.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Izmir Democracy University
• Investigators: Study Director: GÜLŞAH BARĞI, Izmir Democracy University; Principal Investigator: ESRA SUDE AKIN, Izmir Democracy University; Principal Investigator: DEFNE FİL, Izmir Democracy University; Principal Investigator: ERKAN ALPASLAN, Izmir Democracy University

Publications and helpful links

General Publications

• Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.
• Aktan R, Ocaker Aktan O, Ozalevli S, Dursun H. Impact of Inspiratory Muscle Strength and Lung Function on Functional Exercise Capacity in Post-myocardial Infarction Patients: A Cross-sectional Study. Thorac Res Pract. 2025 Oct 24;26(6):307-313. doi: 10.4274/ThoracResPract.2025.2025-7-5. Epub 2025 Sep 18.

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 1, 2026
• First Posted (Actual): February 9, 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: quality of life; muscle strength; pulmonary function; cough; ventricular premature complexes,
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Respiration Disorders; Signs and Symptoms, Respiratory; Cardiac Complexes, Premature; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cough; Ventricular Premature Complexes; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Plastics; Polyvinyls; Vinyl Compounds; Elastomers; Polyvinyl Chloride
• Other Study ID Numbers: Premature Ventricular Complex

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No