Investigation of Respiratory Functions, Muscle Strength, Physical Activity Level, and Quality of Life in Individuals With Premature Ventricular Complexes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Maximal inspiratory pressure (MIP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ventricular premature complexes group
This group will consist of individuals with premature ventricular complex.
干预措施: Physical Evaluations of Patients with Premature Ventricular Complex (Other)
Control Group
This group will consist of healthy individuals.
干预措施: Physical Evaluations of Healthy Individuals (Other)
结局指标
主要结局
Maximal inspiratory pressure (MIP)
时间窗: 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.
次要结局
- Assessment of Quality of Life(through study completion, an average of 1 year)
- Maximal expiratory pressure (MEP)(through study completion, an average of 1 year)
- Forced vital capacity (FVC)(through study completion, an average of 1 year)
- Forced expiratory volume in the first second (FEV1)(through study completion, an average of 1 year)
- FEV1 / FVC(through study completion, an average of 1 year)
- Peak flow rate (PEF)(through study completion, an average of 1 year)
- Cough Strength(through study completion, an average of 1 year)
- Handgrip Strength(through study completion, an average of 1 year)
- Assessment of Physical Activity(through study completion, an average of 1 year)
研究者
Gulsah Bargi
Principal Investigator
Izmir Democracy University