Investigation of the Effect of Inspiratory Muscle Training and Dual-Task Inspiratory Muscle Train… (NCT07581587) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Investigation of the Effect of Inspiratory Muscle Training and Dual-Task Inspiratory Muscle Training on Cognitive Functions in Heart Failure
Turkey (Türkiye)54 participantsStarted 2026-05
Plain-language 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
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Global cognitive function
Timeframe: Baseline and 8 weeks (post-intervention)
2
Subjective cognitive function
Timeframe: Baseline and 8 weeks (post-intervention)
3
Attention and executive function
Timeframe: Baseline and 8 weeks (post-intervention)
4
Verbal memory
Timeframe: Baseline and 8 weeks (post-intervention)
5
Reaction time
Timeframe: Baseline and 8 weeks (post-intervention)