Investigation of the Effect of Inspiratory Muscle Training and Dual-Task Inspiratory Muscle Training on Cognitive Functions in Heart Failure

NCT07581587 | Not Yet Recruiting

• 1 other identifier: 952129
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Keywords

Inspiratory muscle training; IMT; Dual-task

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline and 8 weeks (post-intervention)

• 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.

  Baseline and 8 weeks (post-intervention)

• 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.

  Baseline and 8 weeks (post-intervention)

• 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.

  Baseline and 8 weeks (post-intervention)

• Reaction time

  Reaction time will be assessed using a BlazePod reaction kits. Participants, seated in front of a table, will respond to randomly illuminated light stimuli by tapping the lights as quickly as possible for 30 seconds using one hand. The system consists of four reaction pods positioned in a straight line at 20 cm intervals. Outcome measures will include total number of hits, total reaction time, and mean reaction time per stimulus. Missed responses will be recorded when the light deactivates before being tapped within 4 seconds. Lower reaction time indicates better performance.

  Baseline and 8 weeks (post-intervention)

Secondary Outcomes (16)

• Forced vital capacity

  Baseline and 8 weeks (post-intervention)

• Forced expiratory volume in 1 second (FEV1)

  Baseline and 8 weeks (post-intervention)

• FEV1/FVC

  Baseline and 8 weeks (post-intervention)

• Peak expiratory flow

  Baseline and 8 weeks (post-intervention)

• Forced expiratory flow at 25-75% of FVC

  Baseline and 8 weeks (post-intervention)

Study Arms (3)

Dual-Task IMT

EXPERIMENTAL

Participants will receive IMT combined with simultaneous cognitive tasks for 8 weeks (5 days/week, 2 sessions/day). One session per week will be supervised, and the remaining sessions will be performed via telerehabilitation. Training intensity will be set at 50% of MIP and adjusted weekly.

Behavioral: Dual-Task IMT

Standard IMT

EXPERIMENTAL

Participants will receive IMT alone for 8 weeks (5 days/week, 2 sessions/day). One session per week will be supervised, and the remaining sessions will be performed via telerehabilitation. Training intensity will be set at 50% of MIP and adjusted weekly.

Behavioral: IMT

Control (Usual Care)

NO INTERVENTION

Participants will not receive any additional intervention and will continue their usual medical care. Assessments will be performed at baseline and after 8 weeks.

Interventions

Dual-Task IMT BEHAVIORAL

IMT 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.

Also known as: Cognitive-Motor IMT, Cognitive-Motor Dual-Task, Dual-Task

Dual-Task IMT

IMT BEHAVIORAL

IMT 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.

Also known as: Inspiratory Muscle Training

Standard IMT

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa, Cardiology Institute

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rengin Demir, Prof. Dr.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Vildan Fidanoglu, PT, MSc

CONTACT

212-924-24-44; fzt.vildanbayraktaroglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)