Physical Impairments in Premature Ventricular Complex

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIzmir Democracy University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Physical Evaluations of Patients with Premature Ventricular Complex

    Other intervention

    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.

  • Physical Evaluations of Healthy Individuals

    Other intervention

    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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Ventricular premature complexes group1 intervention
Group B: Control Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

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.

Time frame
through study completion, an average of 1 year
2

Forced vital capacity (FVC)

Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer.

Time frame
through study completion, an average of 1 year
3

Forced expiratory volume in the first second (FEV1)

Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.

Time frame
through study completion, an average of 1 year
4

FEV1 / FVC

Pulmonary function (Forced expiratory volume in the first second/Forced vital capacity (FEV1 / FVC)) will be evaluated with a spirometer.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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