Acute Decompensated Heart FailureNCT04834336
Inspiratory Muscle Training in Acute Decompensated Heart Failure
A study testing inspiratory muscle training device and Physical training in people with Acute Decompensated Heart Failure, run by Dokuz Eylul University.
Trial summary
Hospitalized patients with acute decompensated heart failure (ADHF) present a high prevalence of inspiratory muscle weakness on admission and discharge. Inspiratory muscle training has been reported as a beneficial approach in chronic heart failure. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- inspiratory muscle training device and Physical training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 1 Apr 2024
- Phase
- Interventional
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The management of a diagnosis of ADHF over 24 hours in a hospital setting
- Hemodynamic stability
- The independence of basic activities of daily life before admission
Who cannot join
- Acute myocardial infarction
- Congenital heart disease
- Endocarditis, miyocarditis or pericarditis
- Morbid obesity
- Already participating in cardiac rehabilitation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Inspiratory Muscle Training in Patients With Acute Decompensated Heart Failure
Hospitalized patients with acute decompensated heart failure (ADHF) present a high prevalence of inspiratory muscle weakness on admission and discharge. Inspiratory muscle training has been reported as a beneficial approach in chronic heart failure. However, the effects of inspiratory muscle training in hospitalized patients with ADHF have been not known. The aim of this study is to investigate the safety, feasibility, and effects of inspiratory muscle training in hospitalized patients with ADHF.
Read the detailed description
The participants will randomly be allocated into two groups: (1) Physical training plus inspiratory muscle training, (2) Physical training
Participants in the physical training plus inspiratory muscle training group will perform inspiratory muscle training and physical training. Inspiratory muscle training will be applied with an electronic device. Physical training will be implemented as balance, mobility, functional strength, endurance exercises. During the hospitalization, the inspiratory muscle training will be carried out twice a day with mild to moderate whereas physical training will be carried out once a day. The physical training group will perform only physical training. Physical training will be implemented as balance, mobility, functional strength, endurance exercises. During the hospitalization, physical training will be carried out once a day. For the safety and feasibility of inspiratory muscle training, data will be collected daily during the hospitalization. For effects of inspiratory muscle training, data will be collected at baseline and hospital discharge.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- inspiratory muscle training device, Physical training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle training deviceDevice
Inspiratory muscle training will be performed with an inspiratory muscle training device.
Physical trainingOther
Physical training will be performed with exercise including balance, mobility, functional strength, and endurance.
| Study group | Role | What they receive |
|---|---|---|
| Physical training plus inspiratory muscle training | Experimental | Inspiratory Muscle Training (IMT) will be implemented by using the Power Breathe® device. IMT training will begin with mild to moderate intensity of maximal inspiratory pressure. It will be performed 6 to 10 breaths, 4 sets, and twice daily during the hospitalization when as soon as hemodynamic stability is provided.
Physical Training will consist of each functional domain (balance, mobility, strength, and endurance) according to patients' functional levels. These will include static and dynamic balance training, mobility training, functional strength training focused on lower extremities, and endurance training as sustained walking. A daily 30 min session during the hospitalization will be performed with one-on-one supervision when as soon as hemodynamic stability is provided. Receives: Device: inspiratory muscle training device; Other: Physical training |
| Physical training | Active comparator | Physical Training will consist of each functional domain (balance, mobility, strength, and endurance) according to patients' functional levels. These will include static and dynamic balance training, mobility training, functional strength training focused on lower extremities, and endurance training as sustained walking. A daily 30 min session during the hospitalization will be performed with one-on-one supervision when as soon as hemodynamic stability is provided. Receives: Other: Physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure
Maximal inspiratory pressure will be measured by an electronic mouth pressure device (cmH2O)
Measured: baseline and hospital discharge, an average of 4 to 10 days
Secondary outcomes (13)
Adverse events
The number of adverse events resulting from the intervention will be noted. Adverse events include blood pressure greater than 170/100 mmHg, desaturation of oxygen greater than 4%, severe musculoskeletal and/or chest pain, dyspnea greater than 6 on the Borg scale, dizziness, nausea, vomiting, bleeding, loss or obstruction of the central or peripheral catheter.
Measured: During the hospitalization, daily, during an average of 4 to 10 days
Recruitment rate
The number of participants divided by the total number of eligible patients (%)
Measured: During the hospitalization, daily, during an average of 4 to 10 days
Adherence rate
The number of training sessions divided by the total number of potential sessions (%)
Measured: During the hospitalization, daily, during an average of 4 to 10 days
Retention rate
The number of patients who complete the protocol divided by the total number of patients included in the study (%)
Measured: During the hospitalization, daily, during an average of 4 to 10 days
New York Heart Association Functional Classification
Functional Classification will be assessed with New York Heart Association (NYHA) Functional Classification. The minimum value is 1 whereas the maximum value is 4. Higher scores indicate the lower functional class.
Measured: baseline and hospital discharge, an average of 4 to 10 days
Dyspnea
Dyspnea will be assessed by using the Modified Medical Research Council Scale. It is a 5-item scale. Higher scores indicate higher dyspnea perception.
Measured: baseline and hospital discharge, an average of 4 to 10 days
Hand Grip Strength
Hand grip strength will be measured by a dynamometer.
Measured: baseline and hospital discharge, an average of 4 to 10 days
Physical Performance
Physical performance will be measured by Short Physical Performance Battery (SPPB). SPPB comprises 5 times sit-to-stand, standing balance and 4-m gait speed. The total score ranges from 0 to 12 and a higher score indicates better physical performance.
Measured: baseline and hospital discharge, an average of 4 to 10 days
Frailty
Frailty will be assessed by using the Clinical Frailty Scale (CFS). CFS scores on a scale from 1 (very fit) to 9 (terminally ill).
Measured: baseline and hospital discharge, an average of 4 to 10 days
Cardiac autonomic function
Cardiac autonomic function will be evaluated with heart rate variability analysis by using a SphygmoCor ® device.
Measured: baseline and hospital discharge, an average of 4 to 10 days
Arterial Stiffness
Arterial stiffness will be measured by augmentation index using a SphygmoCor® device.
Measured: baseline and hospital discharge, an average of 4 to 10 days
Disability
Disability will be assessed by using Barthel Index. It occurs 10 questions and the score ranges from 0 to 100. Higher scores indicate greater independence.
Measured: baseline and hospital discharge, an average of 4 to 10 days
One-year mortality
The mortality rate during the first year following hospital discharge
Measured: one year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Jan 2023 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Tanriverdi, Dokuz Eylul University
- Investigators
- Sema Savci, Prof, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834336
- Sponsor's protocol ID
- 5883-GOA
- Status last verified
- Oct 2022
- First submitted
- 1 Apr 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT04834336
- Acronym / sponsor ID
- 5883-GOA
- Conditions
- Acute Decompensated Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 8 Apr 2021 (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.
Hospitalized patients with acute decompensated heart failure (ADHF) present a high prevalence of inspiratory muscle weakness on admission and discharge. Inspiratory muscle training has been reported as a beneficial approach in chronic heart failure. However, the effects of inspiratory muscle training in hospitalized patients with ADHF have been not known. The aim of this study is to investigate the safety, feasibility, and effects of inspiratory muscle training in hospitalized patients with ADHF.
Detailed description
The participants will randomly be allocated into two groups: (1) Physical training plus inspiratory muscle training, (2) Physical training
Participants in the physical training plus inspiratory muscle training group will perform inspiratory muscle training and physical training. Inspiratory muscle training will be applied with an electronic device. Physical training will be implemented as balance, mobility, functional strength, endurance exercises. During the hospitalization, the inspiratory muscle training will be carried out twice a day with mild to moderate whereas physical training will be carried out once a day. The physical training group will perform only physical training. Physical training will be implemented as balance, mobility, functional strength, endurance exercises. During the hospitalization, physical training will be carried out once a day. For the safety and feasibility of inspiratory muscle training, data will be collected daily during the hospitalization. For effects of inspiratory muscle training, data will be collected at baseline and hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical training plus inspiratory muscle training | Experimental | Device: inspiratory muscle training device, Other: Physical trainingInspiratory Muscle Training (IMT) will be implemented by using the Power Breathe® device. IMT training will begin with mild to moderate intensity of maximal inspiratory pressure. It will be performed 6 to 10 breaths, 4 sets, and twice daily during the hospitalization when as soon as hemodynamic stability is provided. Physical Training will consist of each functional domain (balance, mobility, strength, and endurance) according to patients' functional levels. These will include static and dynamic balance training, mobility training, functional strength training focused on lower extremities, and endurance training as sustained walking. A daily 30 min session during the hospitalization will be performed with one-on-one supervision when as soon as hemodynamic stability is provided. |
| Physical training | Active comparator | Other: Physical trainingPhysical Training will consist of each functional domain (balance, mobility, strength, and endurance) according to patients' functional levels. These will include static and dynamic balance training, mobility training, functional strength training focused on lower extremities, and endurance training as sustained walking. A daily 30 min session during the hospitalization will be performed with one-on-one supervision when as soon as hemodynamic stability is provided. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The management of a diagnosis of ADHF over 24 hours in a hospital setting
- Hemodynamic stability
- The independence of basic activities of daily life before admission
Key exclusion criteria (5 listed)
- Acute myocardial infarction
- Congenital heart disease
- Endocarditis, miyocarditis or pericarditis
- Morbid obesity
- Already participating in cardiac rehabilitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle training deviceInspiratory muscle training will be performed with an inspiratory muscle training device. | Device | Physical training plus inspiratory muscle training |
| Physical trainingPhysical training will be performed with exercise including balance, mobility, functional strength, and endurance. | Other | Physical training, Physical training plus inspiratory muscle training |
Primary outcome
Maximal Inspiratory Pressure
Time frame: baseline and hospital discharge, an average of 4 to 10 days
Maximal inspiratory pressure will be measured by an electronic mouth pressure device (cmH2O)
13 secondary outcomes
Adverse events
Time frame: During the hospitalization, daily, during an average of 4 to 10 days
Recruitment rate
Time frame: During the hospitalization, daily, during an average of 4 to 10 days
Adherence rate
Time frame: During the hospitalization, daily, during an average of 4 to 10 days
Retention rate
Time frame: During the hospitalization, daily, during an average of 4 to 10 days
New York Heart Association Functional Classification
Time frame: baseline and hospital discharge, an average of 4 to 10 days
Dyspnea
Time frame: baseline and hospital discharge, an average of 4 to 10 days
Hand Grip Strength
Time frame: baseline and hospital discharge, an average of 4 to 10 days
Physical Performance
Time frame: baseline and hospital discharge, an average of 4 to 10 days
Frailty
Time frame: baseline and hospital discharge, an average of 4 to 10 days
Cardiac autonomic function
Time frame: baseline and hospital discharge, an average of 4 to 10 days
Arterial Stiffness
Time frame: baseline and hospital discharge, an average of 4 to 10 days
Disability
Time frame: baseline and hospital discharge, an average of 4 to 10 days
One-year mortality
Time frame: one year after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Acute Decompensated Heart Failure
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
Acute Decompensated Heart Failure (ADHF)
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated Heart Failure
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.
Sema Savci, Prof study director
Dokuz Eylul University
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training device and Physical training in people with Acute Decompensated Heart Failure, run by Dokuz Eylul University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aylin Tanriverdi (+905352359989, tanrverdiaylin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (time frame: baseline and hospital discharge, an average of 4 to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2022.