## Protocol Section
### Identification Module
**NCT ID:** NCT06428227

**Brief Title:** 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

#### Organization Study ID Info
**ID:** GaziU5
#### Organization
**Class:** OTHER
**Full Name:** Gazi University
### Status Module
#### Completion Date
**Date:** 2024-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-01-01

**Type:** ACTUAL

#### Start Date
**Date:** 2010-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Gazi University

#### Responsible Party

**Investigator Affiliation:** Gazi University

**Investigator Full Name:** Meral Boşnak Güçlü

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Heart Failure

**Keywords:**

- heart failure

- exercise capacity

- respiratory muscle

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 102

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Exercise capacity (6 minute walking test), pulmonary function (spirometry), respiratory muscle strength (mouth pressure device), peripheral muscle strength (hand-held dynometer), dyspnea (The Modified Medical Research Council (MMRC) dyspnea scale), fatigue (Fatigue Severity Scale), quality of life (The Short Form 36 (SF-36) questionnaire), physical activity level (The International Physical Activity Questionnaire) were evaluated.

**Label:** Heart failure patients with inspiratory muscle weakness

#### Arm Group 2

**Description:** Exercise capacity (6 minute walking test), pulmonary function (spirometry), respiratory muscle strength (mouth pressure device), peripheral muscle strength (hand-held dynometer), dyspnea (The Modified Medical Research Council (MMRC) dyspnea scale), fatigue (Fatigue Severity Scale), quality of life (The Short Form 36 (SF-36) questionnaire), physical activity level (The International Physical Activity Questionnaire) were evaluated.

**Label:** Heart failure patients without inspiratory muscle weakness

#### Arm Group 3

**Description:** Exercise capacity (6 minute walking test), pulmonary function (spirometry), respiratory muscle strength (mouth pressure device), peripheral muscle strength (hand-held dynometer), dyspnea (The Modified Medical Research Council (MMRC) dyspnea scale), fatigue (Fatigue Severity Scale), quality of life (The Short Form 36 (SF-36) questionnaire), physical activity level (The International Physical Activity Questionnaire) were evaluated.

**Label:** Healthy controls

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Functional exercise capacity

**Time Frame:** First day

#### Secondary Outcomes

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

**Measure:** Pulmonary function FEV1

**Time Frame:** First day

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

**Measure:** Pulmonary function FVC

**Time Frame:** First day

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

**Measure:** Pulmonary function FEV1/FVC

**Time Frame:** First day

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

**Measure:** Pulmonary function PEF

**Time Frame:** First day

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

**Measure:** Pulmonary function FEF25-75

**Time Frame:** First day

**Description:** Respiratory muscle strength (maximal inspiratory pressure , maximal expiratory pressure; MIP, MEP) was evaluated with a mouth pressure device according to ATS/ERS guidelines.

**Measure:** Respiratory muscle strength

**Time Frame:** First day

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

**Measure:** Peripheral muscle strength

**Time Frame:** First day

**Description:** 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.

**Measure:** Dyspnea

**Time Frame:** First day

**Description:** The Fatigue Severity Scale (FSS) was used to identify fatigue. The total score ranges from 0 to 63. Scores above 36 indicate severe fatigue.

**Measure:** Fatigue

**Time Frame:** First day

**Description:** 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.

**Measure:** The quality of life

**Time Frame:** Fist day

**Description:** 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

**Measure:** Physical activity level

**Time Frame:** First day

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

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

**State:** Çankaya

**Zip:** 06490

#### Overall Officials

**Official 1:**

**Affiliation:** Gazi University

**Name:** Meral Boşnak Güçlü, Prof. Dr

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Mustafa Kemal University

**Name:** Nihan Katayıfçı, Dr.

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**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.

**PMID:** 37839949

**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.

**PMID:** 35619283

**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.

**PMID:** 26528451

**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.

**PMID:** 29289723

**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.

**PMID:** 31204872

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: LOW

- As Found: Unknown

- ID: M20944

- Name: Muscle Weakness

- Relevance: HIGH

- As Found: Muscle Weakness

- ID: M13204

- Name: Paresis

- Relevance: HIGH

- As Found: Muscle Weakness

- ID: M4554

- Name: Asthenia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018908

- Term: Muscle Weakness

- ID: D000010291

- Term: Paresis

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-31
