Exercise Capacity and Fatigue in Heart Failure Patients With and Without Inspiratory Muscle Weakness
- Conditions
- Heart Failure
- Registration Number
- NCT06428227
- Lead Sponsor
- Gazi University
- Brief Summary
In patients with heart failure, diaphragm dysfunction contributes to decreased quality of life while simultaneously increasing morbidity and mortality. Inspiratory muscle weakness is observed in 30-50% of patients, with the severity of weakness increasing as the disease progresses. Patients exhibit reduced exercise capacity, peripheral and respiratory muscle strength, decreased respiratory function, increased dyspnea, fatigue, and worsened quality of life. However, it is unclear how these parameters will change in patients with inspiratory muscle weakness. Therefore, the study aimed to compare functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without inspiratory muscle weakness and healthy controls
- Detailed Description
It is believed that respiratory muscle abnormalities develop earlier and more extensively than extremity muscle abnormalities in heart failure. Diaphragm dysfunction contributes to decreased quality of life while simultaneously increasing morbidity and mortality. Inspiratory muscle weakness is observed in 30-50% of patients, with the severity of weakness increasing as the disease progresses. Heart failure patients exhibit increased airway resistance and ventilatory response during exercise. Fatigue and dyspnea are common symptoms associated with exercise intolerance and decreased quality of life in heart failure patients.There is no study in the literature comparing functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without inspiratory muscle weakness (IMW). The aim of the study was to compare functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without IMW and healthy controls.
The study was planned as a cross-sectional, retrospective. Heart failure patient were divided into IMW group or not IMW group due to their MIP values. Also healthy controls who were matched for age-gender were included.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- HF patients were being aged over18 years
- clinically stable at least four weeks
- having no change in medications over three months
The inclusion criteria for healthy controls were being aged over 18 without a chronic disease
- having unstable angina, acute myocardial infarction, uncontrolled hypertension, significant valvular disease, history of malignancy or orthopedic, rheumatologic, neurological, or pulmonary diseases
The exclusion criteria for the healthy controls were having any chronic or systemic disease, and having physical limitation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional exercise capacity First day According to the American Thoracic Society (ATS) guidelines, the 6-minute walk test (6MWT) was used to evaluate functional exercise capacity
- Secondary Outcome Measures
Name Time Method Pulmonary function FVC First day Pulmonary function FVC was assessed by a spirometer according to the ATS/ERS criteria
Pulmonary function PEF First day Pulmonary function PEF was assessed by a spirometer according to the ATS/ERS criteria
Pulmonary function FEF25-75 First day Pulmonary function FEF25-75 was assessed by a spirometer according to the ATS/ERS criteria
Respiratory muscle strength First day Respiratory muscle strength (maximal inspiratory pressure , maximal expiratory pressure; MIP, MEP) was evaluated with a mouth pressure device according to ATS/ERS guidelines.
Peripheral muscle strength First day Peripheral muscle strength was assessed by using a hand-held dynamometer
Physical activity level First day The International Physical Activity Questionnaire (IPAQ) was used to evaluate physical activity level. The total scores of \<600 MET-min/week, 600-3000 MET-min/week, and \>3000 MET-min/ week were classified as inactive, minimally active, and sufficiently active, respectively
Pulmonary function FEV1 First day Pulmonary function FEV1 was assessed by a spirometer according to the ATS/ERS criteria
Pulmonary function FEV1/FVC First day Pulmonary function FEV1/FVC was assessed by a spirometer according to the ATS/ERS criteria
Fatigue First day The Fatigue Severity Scale (FSS) was used to identify fatigue. The total score ranges from 0 to 63. Scores above 36 indicate severe fatigue.
Dyspnea First day The dyspnea was assessed with The Modified Medical Research Council (MMRC)dyspnea scale. Levels of dyspnea were graded 0-4. Higher scores mean a worse dyspnea level.
The quality of life Fist day Quality of life was evaluated with The Short Form 36 (SF-36) questionnaire. The scores range from 0 to 100. Higher values are indicative of better health.
Trial Locations
- Locations (1)
Gazi University Facutly of Health Sciences Department of Physiotheraphy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
🇹🇷Ankara, Çankaya, Turkey