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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06428227
• Other study ID #: GaziU5
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2024
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Muscle Weakness
• Paresis

Locations

Country	Name	City	State
Turkey	Gazi University Facutly of Health Sciences Department of Physiotheraphy and Rehabilitation, Cardiopulmonary Rehabilitation Unit	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View Citation

Lista-Paz A, Langer D, Barral-Fernandez M, Quintela-Del-Rio A, Gimeno-Santos E, Arbillaga-Etxarri A, Torres-Castro R, Vilaro Casamitjana J, Varas de la Fuente AB, Serrano Veguillas C, Bravo Cortes P, Martin Cortijo C, Garcia Delgado E, Herrero-Cortina B, Valera JL, Fregonezi GAF, Gonzalez Montanez C, Martin-Valero R, Francin-Gallego M, Sanesteban Hermida Y, Gimenez Moolhuyzen E, Alvarez Rivas J, Rios-Cortes AT, Souto-Camba S, Gonzalez-Doniz L. Maximal Respiratory Pressure Reference Equations in Healthy Adults and Cut-off Points for Defining Respiratory Muscle Weakness. Arch Bronconeumol. 2023 Dec;59(12):813-820. doi: 10.1016/j.arbres.2023.08.016. Epub 2023 Sep 29. English, Spanish. — View 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. — View Citation

Silva Andrade NS, Almeida L, Noronha I, Lima JM, Eriko Tenorio de Franca E, Pedrosa R, Siqueira F, Onofre T. Analysis of respiratory muscle strength and its relationship with functional capacity between different field tests in patients with heart failure. Physiother Theory Pract. 2023 Nov 2;39(11):2427-2437. doi: 10.1080/09593985.2022.2077270. Epub 2022 May 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional exercise capacity	According to the American Thoracic Society (ATS) guidelines, the 6-minute walk test (6MWT) was used to evaluate functional exercise capacity	First day
Secondary	Pulmonary function FEV1	Pulmonary function FEV1 was assessed by a spirometer according to the ATS/ERS criteria	First day
Secondary	Pulmonary function FVC	Pulmonary function FVC was assessed by a spirometer according to the ATS/ERS criteria	First day
Secondary	Pulmonary function FEV1/FVC	Pulmonary function FEV1/FVC was assessed by a spirometer according to the ATS/ERS criteria	First day
Secondary	Pulmonary function PEF	Pulmonary function PEF was assessed by a spirometer according to the ATS/ERS criteria	First day
Secondary	Pulmonary function FEF25-75	Pulmonary function FEF25-75 was assessed by a spirometer according to the ATS/ERS criteria	First day
Secondary	Respiratory muscle strength	Respiratory muscle strength (maximal inspiratory pressure , maximal expiratory pressure; MIP, MEP) was evaluated with a mouth pressure device according to ATS/ERS guidelines.	First day
Secondary	Peripheral muscle strength	Peripheral muscle strength was assessed by using a hand-held dynamometer	First day
Secondary	Dyspnea	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.	First day
Secondary	Fatigue	The Fatigue Severity Scale (FSS) was used to identify fatigue. The total score ranges from 0 to 63. Scores above 36 indicate severe fatigue.	First day
Secondary	The quality of life	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.	Fist day
Secondary	Physical activity level	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	First day