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Fysiske funksjonsnedsettelser ved for tidlige ventrikulære ekstraslag

3. november 2026 oppdatert av: Gulsah Bargi, Izmir Democracy University

Undersøkelse av respirasjonsfunksjoner, muskelstyrke, fysisk aktivitetsnivå og livskvalitet hos personer med for tidlige ventrikulære ekstraslag

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

52

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: ESRA SUDE AKIN
  • Telefonnummer: +90 232 299 0739

Studiesteder

  • Tyrkia (Türkiye)
      • Izmir, Tyrkia (Türkiye), 35140
        • Rekruttering
        • Izmir Democracy University
        • Ta kontakt med:
          • GÜLŞAH BARĞI
          • Telefonnummer: 0232 299 0739
        • Ta kontakt med:
          • ESRA SUDE AKIN

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: CASE_CONTROL
  • Tidsperspektiver: CROSS_SECTIONAL

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Ventricular premature complexes group

This group will consist of individuals with premature ventricular complex.
Annen: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximal inspiratory pressure (MIP)
Tidsramme: through study completion, an average of 1 year

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximal expiratory pressure (MEP)
Tidsramme: through study completion, an average of 1 year

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)
Tidsramme: through study completion, an average of 1 year

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)
Tidsramme: through study completion, an average of 1 year

Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.
through study completion, an average of 1 year
FEV1 / FVC
Tidsramme: through study completion, an average of 1 year

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
Peak flow rate (PEF)
Tidsramme: through study completion, an average of 1 year

Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.
through study completion, an average of 1 year
Cough Strength
Tidsramme: through study completion, an average of 1 year

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
Tidsramme: through study completion, an average of 1 year

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
Tidsramme: through study completion, an average of 1 year

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
Assessment of Quality of Life
Tidsramme: through study completion, an average of 1 year

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Izmir Democracy University

Etterforskere

  • Hovedetterforsker: ESRA SUDE AKIN, Izmir Democracy University
  • Hovedetterforsker: DEFNE FİL, Izmir Democracy University
  • Hovedetterforsker: ERKAN ALPASLAN, Izmir Democracy University
  • Studieleder: GÜLŞAH BARĞI, Izmir Democracy University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. juli 2026

Primær fullføring (Antatt)

1. mars 2028

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

1. februar 2026

Først innsendt som oppfylte QC-kriteriene

1. februar 2026

Først lagt ut (Faktiske)

9. februar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Premature Ventricular Complex

Plan for individuelle deltakerdata (IPD)

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Nei

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Nei

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