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
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
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
Parallel
Dual-Task IMT
BehavioralIMT will be applied using a threshold loading device at 50% of MIP for 8 weeks (5 days/week, 2 sessions/day, 15 minutes each). One session per week will be supervised, and the remaining sessions will be performed via telerehabilitation. During IMT, participants will simultaneously perform cognitive tasks targeting attention, memory, and executive functions, which will be varied weekly to minimize learning effects.
IMT
BehavioralIMT will be applied using a threshold loading device at 50% of MIP for 8 weeks (5 days/week, 2 sessions/day, 15 minutes each). One session per week will be supervised, and the remaining sessions will be performed via telerehabilitation. No additional cognitive task will be applied during training.
Global cognitive function
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), 0-30 point screening tool evaluating multiple cognitive domains including attention, memory, executive functions, visuospatial abilities, and language. Higher scores indicate better cognitive performance. The assessment will be administered by a certified physiotherapist.
Subjective cognitive function
Subjective cognitive function will be assessed using the Cognitive Failures Questionnaire (CFQ), which evaluates perceived cognitive performance over the past 6 months. The questionnaire consists of 25 items rated on a 5-point Likert scale (0-4), with total scores ranging from 0 to 100. Higher scores indicate greater perceived cognitive impairment.
Attention and executive function
Attention and executive function will be assessed using a Stroop Test (The Scientific and Technological Research Council of Türkiye, Basic Sciences Research Group version), a standardized tool evaluating selective attention, cognitive flexibility, and psychomotor speed. The test consists of five sections, and completion time, as well as the number of correct and incorrect responses, will be recorded for each section. Longer completion times and higher error rates indicate poorer performance.
Verbal memory
Verbal memory will be assessed using the Öktem Verbal Memory Processes Test, which evaluates different components of verbal memory including learning, delayed recall, and recognition. The test involves repeated presentation of a target word list, followed by delayed recall and recognition tasks. Performance will be quantified using learning, spontaneous recall, and recognition scores. The learning score reflects total words recalled across repeated trials (maximum 15). Spontaneous recall is assessed approximately 40 minutes after the learning phase, during which participants are asked to recall the words without cueing. Recognition performance is based on identifying previously presented words among distractors. Higher scores indicate better verbal memory performance.
Forced vital capacity
Forced vital capacity (FVC) will be assessed using spirometry according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. It will be recorded from three acceptable maneuvers performed in a seated position, and the highest value will be used for analysis.
Forced expiratory volume in 1 second (FEV1)
Forced expiratory volume in 1 second (FEV1) will be assessed using spirometry according to ATS/ERS guidelines. It will be recorded from three acceptable maneuvers performed in a seated position, and the highest value will be used for analysis.
FEV1/FVC
FEV1/FVC ratio will be assessed using spirometry according to ATS/ERS guidelines. It will be recorded from three acceptable maneuvers performed in a seated position, and the highest value will be used for analysis.
Peak expiratory flow
Peak expiratory flow (PEF) will be assessed using spirometry according to ATS/ERS guidelines. It will be recorded from three acceptable maneuvers performed in a seated position, and the highest value will be used for analysis.
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Istanbul University - Cerrahpasa
Lead sponsor
Halic University
Sponsor institution
