Heart FailureNCT06428227
Exercise Capacity and Fatigue in Heart Failure Patients With and Without Inspiratory Muscle Weakness
An observational study of Heart Failure, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2010to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Facutly of Health Sciences Department of Physiotheraphy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, 06490
About this study
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
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
Read the 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
- Heart Failure
- Keywords
- heart failure, exercise capacity, respiratory muscle
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients with inspiratory muscle weakness | 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. | |
| Heart failure patients without inspiratory muscle weakness | 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. | |
| Healthy controls | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
According to the American Thoracic Society (ATS) guidelines, the 6-minute walk test (6MWT) was used to evaluate functional exercise capacity
Measured: First day
Secondary outcomes (11)
Pulmonary function FEV1
Pulmonary function FEV1 was assessed by a spirometer according to the ATS/ERS criteria
Measured: First day
Pulmonary function FVC
Pulmonary function FVC was assessed by a spirometer according to the ATS/ERS criteria
Measured: First day
Pulmonary function FEV1/FVC
Pulmonary function FEV1/FVC was assessed by a spirometer according to the ATS/ERS criteria
Measured: First day
Pulmonary function PEF
Pulmonary function PEF was assessed by a spirometer according to the ATS/ERS criteria
Measured: First day
Pulmonary function FEF25-75
Pulmonary function FEF25-75 was assessed by a spirometer according to the ATS/ERS criteria
Measured: First day
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.
Measured: First day
Peripheral muscle strength
Peripheral muscle strength was assessed by using a hand-held dynamometer
Measured: First day
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.
Measured: First day
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.
Measured: First day
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.
Measured: Fist day
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
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jan 2010
- Primary completion1 Jan 2020
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Meral Boşnak Güçlü, Prof. Dr, Study director, Gazi UniversityNihan Katayıfçı, Dr., Study chair, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428227
- Sponsor's protocol ID
- GaziU5
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37839949Silva 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.
PubMed 35619283Kasahara 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.
PubMed 26528451Miyagi 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.
PubMed 29289723Bosnak 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.
PubMed 31204872Katayifci N, Bosnak Guclu M. Inspiratory muscle weakness further impairs exercise capacity and respiratory functions and increases dyspnea perception in patients with heart failure. Sci Rep. 2025 Sep 1;15(1):32229. doi: 10.1038/s41598-025-16492-6.
PubMed 40890240
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06428227
- Acronym / sponsor ID
- GaziU5
- Conditions
- Heart Failure
- Keywords
- heart failure, exercise capacity, respiratory muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients with inspiratory muscle weakness | – | –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. |
| Heart failure patients without inspiratory muscle weakness | – | –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. |
| Healthy controls | – | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
Pulmonary function FEV1
Time frame: First day
Pulmonary function FVC
Time frame: First day
Pulmonary function FEV1/FVC
Time frame: First day
Pulmonary function PEF
Time frame: First day
Pulmonary function FEF25-75
Time frame: First day
Respiratory muscle strength
Time frame: First day
Peripheral muscle strength
Time frame: First day
Dyspnea
Time frame: First day
Fatigue
Time frame: First day
The quality of life
Time frame: Fist day
Physical activity level
Time frame: First day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 37839949Lista-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.
- Background: PubMed 35619283Silva 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.
- Background: PubMed 26528451Kasahara 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.
- Background: PubMed 29289723Miyagi 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.
- Background: PubMed 31204872Bosnak 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.
- Derived from this study: PubMed 40890240Katayifci N, Bosnak Guclu M. Inspiratory muscle weakness further impairs exercise capacity and respiratory functions and increases dyspnea perception in patients with heart failure. Sci Rep. 2025 Sep 1;15(1):32229. doi: 10.1038/s41598-025-16492-6.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meral Boşnak Güçlü, Prof. Dr study director
Gazi University
Nihan Katayıfçı, Dr. study chair
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: First day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06428227, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.