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

29 luglio 2026 aggiornato da: Vildan Fidanoglu, Istanbul University - Cerrahpasa

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

HF is a complex clinical syndrome associated with reduced functional capacity and a high prevalence of cognitive impairment, which negatively affects prognosis and quality of life. Inspiratory muscle weakness is also common in HF and is associated with increased dyspnea and reduced exercise tolerance. The IMT has been shown to improve respiratory and functional outcomes; however, its effects on cognitive function remain unclear. Dual-task approaches, involving the simultaneous performance of motor and cognitive tasks, have been suggested to enhance neurocognitive integration and improve both cognitive and functional performance. Despite this, the effects of IMT applied within a motor-cognitive dual-task framework in HF patients have not been sufficiently investigated. This study is designed as a prospective, randomized controlled, single-blind trial. A total of 54 patients with heart failure will be included and randomly assigned to three groups: control, standard IMT, and dual-task IMT. Both intervention groups will receive IMT at 50% of maximal inspiratory pressure (MIP) for 8 weeks, 5 days per week, 2 sessions per day (15 minutes each). One session per week will be supervised, and the remaining sessions will be conducted via telerehabilitation (4 days/week, 2 sessions per day). Training intensity will be adjusted weekly. In the dual-task IMT group, cognitive tasks targeting attention, memory, and executive functions will be performed simultaneously with IMT. Assessments will be performed before and after the intervention. Primary outcomes will include cognitive function, while secondary outcomes will include respiratory function, inspiratory muscle strength and endurance, exercise capacity, dyspnea, fatigue, nitric oxide levels, frailty, physical performance, quality of life, and psychological status. This study aims to determine the effectiveness of dual-task IMT compared to standard IMT and control conditions, and to provide evidence for integrated rehabilitation approaches in patients with HF.

Tipo di studio

Interventistico

Iscrizione (Stimato)

54

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Fatih
      • Istanbul, Fatih, Turchia (Türkiye), 34098
        • Reclutamento
        • Istanbul University-Cerrahpaşa, Cardiology Institute
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dual-Task IMT
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.
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.
Altri nomi:
  • Cognitive-Motor IMT
  • Cognitive-Motor Dual-Task
  • Dual-Task
Sperimentale: Standard IMT
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.
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.
Altri nomi:
  • Allenamento dei muscoli inspiratori
Nessun intervento: Control (Usual Care)
Participants will not receive any additional intervention and will continue their usual medical care. Assessments will be performed at baseline and after 8 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Global cognitive function
Lasso di tempo: Baseline and 8 weeks (post-intervention)
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
Lasso di tempo: Baseline and 8 weeks (post-intervention)
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
Lasso di tempo: Baseline and 8 weeks (post-intervention)
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
Lasso di tempo: Baseline and 8 weeks (post-intervention)
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
Lasso di tempo: Baseline and 8 weeks (post-intervention)
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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Forced vital capacity
Lasso di tempo: Baseline and 8 weeks (post-intervention)
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.
Baseline and 8 weeks (post-intervention)
Forced expiratory volume in 1 second (FEV1)
Lasso di tempo: Baseline and 8 weeks (post-intervention)
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.
Baseline and 8 weeks (post-intervention)
FEV1/FVC
Lasso di tempo: Baseline and 8 weeks (post-intervention)
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.
Baseline and 8 weeks (post-intervention)
Peak expiratory flow
Lasso di tempo: Baseline and 8 weeks (post-intervention)
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.
Baseline and 8 weeks (post-intervention)
Forced expiratory flow at 25-75% of FVC
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Forced expiratory flow at 25-75% of FVC (FEF25-75) 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.
Baseline and 8 weeks (post-intervention)
Maximal inspiratory pressure
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Maximal inspiratory pressure (MIP) will be assessed using a portable electronic mouth pressure device (MicroRPM; Micro Medical, UK), according to ATS/ERS guidelines. It will be measured in the seated position using a mouthpiece with nasal occlusion. Participants will perform maximal inspiratory effort for at least 2 seconds against an occluded airway. The highest value from three acceptable maneuvers with <10% variability will be recorded in cmH₂O and as a percentage of predicted values using Black and Hyatt reference equations. Higher values indicate better inspiratory muscle strength.
Baseline and 8 weeks (post-intervention)
Maximal expiratory pressure
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Maximal expiratory pressure (MEP) will be assessed using a portable electronic mouth pressure device (MicroRPM; Micro Medical, UK), according to ATS/ERS guidelines. It will be measured in the seated position using a mouthpiece with nasal occlusion. Participants will perform maximal expiratory effort for at least 2 seconds against an occluded airway. The highest value from three acceptable maneuvers with <10% variability will be recorded in cmH₂O and as a percentage of predicted values using Black and Hyatt reference equations. Higher values indicate better expiratory muscle strength.
Baseline and 8 weeks (post-intervention)
Respiratory muscle endurance
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Respiratory muscle endurance will be assessed using a constant-load threshold loading test with a pressure threshold device (POWERbreathe Classic Light Resistance, POWERbreathe International Ltd., UK). The test will be performed at 60% of MIP. Participants will breathe through the device for up to 10 minutes, and endurance will be recorded as the time sustained (seconds) and achieved pressure load (cmH₂O). Higher endurance time indicates better respiratory muscle endurance.
Baseline and 8 weeks (post-intervention)
Exercise capacity
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Exercise capacity will be assessed using the 6-minute walk test (6MWT) according to ATS guidelines. Participants will be instructed to walk as far as possible for 6 minutes along a 30-meter corridor at a self-paced speed. A standardized rest period will be provided prior to testing. Total walking distance will be recorded in meters. Higher walking distance indicates better exercise capacity.
Baseline and 8 weeks (post-intervention)
Dyspnea
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Dyspnea will be assessed using the Modified Medical Research Council (mMRC) Dyspnea Scale, a 0-4 point scale based on the level of physical activity that induces breathlessness. Higher scores indicate greater severity of dyspnea.
Baseline and 8 weeks (post-intervention)
Fatigue
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Fatigue will be assessed using the Fatigue Severity Scale (FSS), a 9-item scale evaluating fatigue severity over the past week. Each item is rated on a 7-point Likert scale (1-7), and the total score is calculated by averaging item scores. A score ≥4 indicates severe fatigue. Higher scores indicate greater fatigue severity.
Baseline and 8 weeks (post-intervention)
Fractional exhaled nitric oxide
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Fractional exhaled nitric oxide (FeNO) will be measured using a NObreath® device (Bedfont Scientific Ltd., UK) according to the ATS guidelines. Measurements will be performed with controlled expiratory flow, and mean values will be recorded. Participants will perform controlled exhalation at a constant flow rate (50 mL/s) following standardized pre-test conditions. The mean of two acceptable measurements will be recorded as FeNO (parts per billion, ppb).
Baseline and 8 weeks (post-intervention)
Frailty
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Frailty will be assessed using the Edmonton Frail Scale, a 17-point scale evaluating multiple domains including cognition, general health status, functional independence, and social support. Scores range from 0 to 17, with higher scores indicating greater frailty severity.
Baseline and 8 weeks (post-intervention)
Physical performance
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Physical performance will be assessed using the Short Physical Performance Battery (SPPB), including balance tests, 4-meter gait speed, and chair stand tests. Total scores range from 0 to 12, with higher scores indicating better performance.
Baseline and 8 weeks (post-intervention)
Quality of life (QoL)
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire, a 21-item disease-specific scale evaluating the physical and emotional impact of the disease over the past 4 weeks. Each item is scored from 0 to 5, with total scores ranging from 0 to 105. Higher scores indicate worse quality of life.
Baseline and 8 weeks (post-intervention)
Anxiety and depression
Lasso di tempo: Baseline and 8 weeks (post-intervention)
Anxiety and depression will be evaluated using the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire with two subscales assessing anxiety and depression. Each subscale ranges from 0 to 21, with higher scores indicating greater symptom severity.
Baseline and 8 weeks (post-intervention)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Direttore dello studio: Rengin Demir, Prof. Dr., Istanbul University - Cerrahpasa

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 luglio 2026

Completamento primario (Stimato)

1 luglio 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

17 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 952129

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .