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NCT Number: NCT06428227

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University Facutly of Health Sciences Department of Physiotheraphy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, 06490, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Pulmonary function FEV1

    Time frame: First day

    Pulmonary function FEV1 was assessed by a spirometer according to the ATS/ERS criteria

  2. Pulmonary function FVC

    Time frame: First day

    Pulmonary function FVC was assessed by a spirometer according to the ATS/ERS criteria

  3. Pulmonary function FEV1/FVC

    Time frame: First day

    Pulmonary function FEV1/FVC was assessed by a spirometer according to the ATS/ERS criteria

  4. Pulmonary function PEF

    Time frame: First day

    Pulmonary function PEF was assessed by a spirometer according to the ATS/ERS criteria

  5. Pulmonary function FEF25-75

    Time frame: First day

    Pulmonary function FEF25-75 was assessed by a spirometer according to the ATS/ERS criteria

  6. Respiratory muscle strength

    Time frame: 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.

  7. Peripheral muscle strength

    Time frame: First day

    Peripheral muscle strength was assessed by using a hand-held dynamometer

  8. Dyspnea

    Time frame: 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.

  9. Fatigue

    Time frame: 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.

  10. The quality of life

    Time frame: 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.

  11. Physical activity level

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2020
Study completion
2024
First posted
May 24, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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