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Exercise Capacity and Fatigue in Heart Failure Patients With and Without Inspiratory Muscle Weakness

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06428227
Enrollment
102
Registered
2024-05-24
Start date
2010-01-01
Completion date
2024-02-01
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, exercise capacity, respiratory muscle

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.

Interventions

None listed

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Functional exercise capacityFirst dayAccording to the American Thoracic Society (ATS) guidelines, the 6-minute walk test (6MWT) was used to evaluate functional exercise capacity

Secondary

MeasureTime frameDescription
Pulmonary function FVCFirst dayPulmonary function FVC was assessed by a spirometer according to the ATS/ERS criteria
Pulmonary function FEV1/FVCFirst dayPulmonary function FEV1/FVC was assessed by a spirometer according to the ATS/ERS criteria
Pulmonary function PEFFirst dayPulmonary function PEF was assessed by a spirometer according to the ATS/ERS criteria
Pulmonary function FEF25-75First dayPulmonary function FEF25-75 was assessed by a spirometer according to the ATS/ERS criteria
Respiratory muscle strengthFirst dayRespiratory muscle strength (maximal inspiratory pressure , maximal expiratory pressure; MIP, MEP) was evaluated with a mouth pressure device according to ATS/ERS guidelines.
Pulmonary function FEV1First dayPulmonary function FEV1 was assessed by a spirometer according to the ATS/ERS criteria
DyspneaFirst dayThe 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.
FatigueFirst dayThe Fatigue Severity Scale (FSS) was used to identify fatigue. The total score ranges from 0 to 63. Scores above 36 indicate severe fatigue.
The quality of lifeFist dayQuality 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.
Physical activity levelFirst dayThe 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
Peripheral muscle strengthFirst dayPeripheral muscle strength was assessed by using a hand-held dynamometer

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026