Physical Impairments in Premature Ventricular Complex

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Maximal inspiratory pressure (MIP) [Time frame: through study completion, an average of 1 year]

Secondary outcome measures (9)

• Maximal expiratory pressure (MEP) [Time frame: through study completion, an average of 1 year]
• Forced vital capacity (FVC) [Time frame: through study completion, an average of 1 year]
• Forced expiratory volume in the first second (FEV1) [Time frame: through study completion, an average of 1 year]
• FEV1 / FVC [Time frame: through study completion, an average of 1 year]
• Peak flow rate (PEF) [Time frame: through study completion, an average of 1 year]
• Cough Strength [Time frame: through study completion, an average of 1 year]
• Handgrip Strength [Time frame: through study completion, an average of 1 year]
• Assessment of Physical Activity [Time frame: through study completion, an average of 1 year]
• Assessment of Quality of Life [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

Turkey (Türkiye) · 1 center

• Izmir Democracy University — Izmir

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 arrhyth PMID 36017572
• 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. PMID 40960384

Identifiers

NCT: NCT07396597 · Premature Ventricular Complex

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗