About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dual-Task IMT
- IMT
Treatment groups
Sponsors and collaborators
Istanbul University - Cerrahpasa
Lead sponsor
Halic University
Sponsor institution