Clinical trial NCT06428227: Exercise Capacity and Fatigue in Heart Failure Patients With and Without Inspiratory Muscle Weakness
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: heart failure
exercise capacity
respiratory muscle
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty-one heart failure patients with inspiratory muscle weakness, 30 heart failure patients without inspiratory muscle weakness and 41 healthy controls were included.

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.

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

Primary outcomes:
measure: Functional exercise capacity
timeFrame: First day
Secondary outcomes:
measure: Pulmonary function FEV1
timeFrame: First day
measure: Pulmonary function FVC
timeFrame: First day
measure: Pulmonary function FEV1/FVC
timeFrame: First day
measure: Pulmonary function PEF
timeFrame: First day
measure: Pulmonary function FEF25-75
timeFrame: First day
measure: Respiratory muscle strength
timeFrame: First day
measure: Peripheral muscle strength
timeFrame: First day
measure: Dyspnea
timeFrame: First day
measure: Fatigue
timeFrame: First day
measure: The quality of life
timeFrame: Fist day
measure: Physical activity level
timeFrame: First day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Facutly of Health Sciences Department of Physiotheraphy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
state: Çankaya
Study officials:
affiliation: Gazi University
name: Meral Boşnak Güçlü, Prof. Dr
role: STUDY_DIRECTOR
affiliation: Mustafa Kemal University
name: Nihan Katayıfçı, Dr.
role: STUDY_CHAIR
References:
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citation: Kasahara Y, Izawa KP, Watanabe S, Osada N, Omiya K. The Relation of Respiratory Muscle Strength to Disease Severity and Abnormal Ventilation During Exercise in Chronic Heart Failure Patients. Res Cardiovasc Med. 2015 Sep 15;4(4):e28944. doi: 10.5812/cardiovascmed.28944. eCollection 2015 Nov.
citation: Miyagi M, Kinugasa Y, Sota T, Yamada K, Ishisugi T, Hirai M, Yanagihara K, Haruki N, Matsubara K, Kato M, Yamamoto K. Diaphragm Muscle Dysfunction in Patients With Heart Failure. J Card Fail. 2018 Apr;24(4):209-216. doi: 10.1016/j.cardfail.2017.12.004. Epub 2017 Dec 28.
citation: Bosnak Guclu M, Bargi G, Katayifci N, Sen F. Comparison of functional and maximal exercise capacity, respiratory and peripheral muscle strength, dyspnea, and fatigue in patients with heart failure with pacemakers and healthy controls: a cross-sectional study. Physiother Theory Pract. 2021 Feb;37(2):295-306. doi: 10.1080/09593985.2019.1630878. Epub 2019 Jun 17.