Investigation of the Effect of Inspiratory Muscle Training and Dual-Task Inspiratory Muscle Training on Cognitive Functions in Heart Failure
Recruiting · NCT07581587 · Interventional (participants receive a specific treatment) · Lead sponsor: Istanbul University - Cerrahpasa
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
1 location listed.
- Istanbul University-Cerrahpaşa, Cardiology Institute - Istanbul, Fatih, Turkey (Türkiye)