NCT07581587 Investigation of the Effect of Inspiratory Muscle Training and Dual-Task Inspiratory Muscle Training on Cognitive Functions in Heart Failure
| NCT ID | NCT07581587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University - Cerrahpasa |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2026-07-27 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2026-07-27 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate whether dual-task inspiratory muscle training (IMT) is effective in improving cognitive and functional outcomes in adults with heart failure. It will also assess the effects of standard IMT and compare both approaches. The main questions it aims to answer are: * Does dual-task IMT improve cognitive function more than standard IMT or no intervention? * Does dual-task IMT improve respiratory function, inspiratory muscle strength, and exercise capacity? * What are the effects of dual-task IMT on symptoms such as dyspnea and fatigue, and on quality of life, anxiety, and depression? Dual-task IMT, standard IMT, and a control group (no additional intervention) will be compared to determine which approach is more effective in patients with heart failure (HF). Participants will: * Be randomly assigned to one of three groups: dual-task IMT, standard IMT, or control * Perform IMT training 5 days per week for 8 weeks (2 sessions per day, 15 minutes each) if assigned to an intervention group * Complete 1 supervised in-person session per week and 4 sessions via telerehabilitation if assigned to an intervention group * Undergo assessments before and after the 8-week intervention, including cognitive tests, respiratory function, exercise capacity, and symptom evaluations
Eligibility Criteria
Inclusion Criteria: * Age ≥ 40 years * Diagnosed with HF with reduced ejection fraction (HFrEF) according to the 2023 ESC HF Guidelines * Classified as NYHA functional class I-III * Clinically stable for at least 3 months and receiving stable pharmacological treatment * Able to read and understand Turkish * MoCA score ≥ 21 * Willingness to participate and provide written informed consent Exclusion Criteria: * Diagnosis of any neurological or neurodegenerative disease (e.g., Parkinson's disease, stroke, dementia, Alzheimer's disease) * Diagnosis of pulmonary disease (e.g., chronic obstructive pulmonary disease, obstructive sleep apnea) * Myocardial infarction within the last 6 months * Uncontrolled hypertension and/or diabetes mellitus * Severe valvular heart disease and/or uncontrolled arrhythmias * Orthopedic, visual, or hearing impairments that may prevent independent test completion * Inability to comply with study procedures or follow instructions
Contact & Investigator
Rengin Demir, Prof. Dr.
STUDY DIRECTOR
Istanbul University - Cerrahpasa
Frequently Asked Questions
Who can join the NCT07581587 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07581587 currently recruiting?
Yes, NCT07581587 is actively recruiting participants. Contact the research team at fzt.vildanbayraktaroglu@hotmail.com for enrollment information.
Where is the NCT07581587 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07581587 clinical trial?
NCT07581587 is sponsored by Istanbul University - Cerrahpasa. The principal investigator is Rengin Demir, Prof. Dr. at Istanbul University - Cerrahpasa. The trial plans to enroll 54 participants.
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