Investigation of the Effect of Inspiratory Muscle Training and Dual-Task Inspiratory Muscle Training on Cognitive Functions in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Global cognitive function
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: IMT (Behavioral)
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.
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.
干预措施: Dual-Task IMT (Behavioral)
结局指标
主要结局
Global cognitive function
时间窗: 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.
Subjective cognitive function
时间窗: 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.
Attention and executive function
时间窗: 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.
Verbal memory
时间窗: 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.
Reaction time
时间窗: 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.
次要结局
- Forced expiratory flow at 25-75% of FVC(Baseline and 8 weeks (post-intervention))
- 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))
- Maximal inspiratory pressure(Baseline and 8 weeks (post-intervention))
- Maximal expiratory pressure(Baseline and 8 weeks (post-intervention))
- Respiratory muscle endurance(Baseline and 8 weeks (post-intervention))
- Exercise capacity(Baseline and 8 weeks (post-intervention))
- Dyspnea(Baseline and 8 weeks (post-intervention))
- Fatigue(Baseline and 8 weeks (post-intervention))
- Fractional exhaled nitric oxide(Baseline and 8 weeks (post-intervention))
- Frailty(Baseline and 8 weeks (post-intervention))
- Physical performance(Baseline and 8 weeks (post-intervention))
- Quality of life (QoL)(Baseline and 8 weeks (post-intervention))
- Anxiety and depression(Baseline and 8 weeks (post-intervention))
研究者
Vildan Fidanoglu
Principal Investigator
Halic University