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Clinical Trials/NCT06428227
NCT06428227
Completed
Not Applicable

A Comparison of Exercise Capacity, Respiratory Functions, and Quality of Life in Heart Failure Patients With and Without Inspiratory Muscle Weakness and Healthy Controls

Gazi University1 site in 1 country102 target enrollmentJanuary 1, 2010
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Gazi University
Enrollment
102
Locations
1
Primary Endpoint
Functional exercise capacity
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2010
End Date
February 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Meral Boşnak Güçlü

Professor

Gazi University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Functional exercise capacity

Time Frame: First day

According to the American Thoracic Society (ATS) guidelines, the 6-minute walk test (6MWT) was used to evaluate functional exercise capacity

Secondary Outcomes

  • Respiratory muscle strength(First day)
  • Pulmonary function FVC(First day)
  • Pulmonary function PEF(First day)
  • Pulmonary function FEF25-75(First day)
  • Peripheral muscle strength(First day)
  • Physical activity level(First day)
  • Pulmonary function FEV1(First day)
  • Pulmonary function FEV1/FVC(First day)
  • Fatigue(First day)
  • Dyspnea(First day)
  • The quality of life(Fist day)

Study Sites (1)

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