Integrating Aerobic, Respiratory, and Cognitive Training in Acute Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Functional Exercise Capacity
研究概览
简要总结
The purpose of this study is to investigate the impact of integrating aerobic, respiratory and cognitive training in acute heart failure.
详细描述
Patients with acute heart failure often experience severe dyspnea, muscle weakness, and cognitive decline during hospitalization, which together impair recovery and increase the risk of rehospitalization. Respiratory muscle dysfunction contributes to exercise intolerance and worsened prognosis, highlighting the importance of targeted inspiratory training. Likewise, immobilization leads to peripheral muscle deconditioning, while cognitive impairment is associated with poor adherence to treatment and lower quality of life.
Pharmacological therapies remain the cornerstone of acute heart failure management; however, they do not directly address these functional and cognitive complications. Consequently, non-pharmacological strategies have gained increasing attention as adjunctive treatments, offering potential benefits without the risks of drug-related side effects.
It is hypothesized that patients with acute heart failure require a multidimensional rehabilitation program that simultaneously supports respiratory, muscular, and cognitive functions. The BLM approach-combining arm ergometer exercise, inspiratory muscle training, and computerized cognitive training-may represent a novel, safe, and effective strategy to accelerate recovery, improve functional outcomes, reduce hospital stay, and potentially lower readmission rates.
Few clinical trials have evaluated such an integrative program in the acute hospital setting. If proven effective, this approach could be incorporated into routine cardiac rehabilitation protocols, providing holistic care that addresses both physical and cognitive dimensions of heart failure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 50-65 years.
- •All patients are male.
- •Diagnosed with acute heart failure according to ESC guidelines.
- •Hemodynamically stable for at least 24 hours.
- •Able to follow simple verbal commands and participate in training.
排除标准
- •Unstable angina or recent myocardial infarction (< 4 weeks).
- •Severe uncontrolled arrhythmias or advanced atrioventricular block.
- •Severe pulmonary disease (e.g., advanced COPD, restrictive lung disease).
- •Neurological disorders causing cognitive or motor disability.
- •Orthopedic or musculoskeletal conditions preventing upper-limb activity.
- •Severe visual or auditory impairment limiting participation in cognitive training.
研究组 & 干预措施
Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy
Twenty patients will receive a comprehensive intervention program consisting of aerobic training, inspiratory muscle training, and cognitive training in addition to conventional therapy. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.
干预措施: Aerobic training (Other)
Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy
Twenty patients will receive a comprehensive intervention program consisting of aerobic training, inspiratory muscle training, and cognitive training in addition to conventional therapy. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.
干预措施: Inspiratory muscle training (Other)
Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy
Twenty patients will receive a comprehensive intervention program consisting of aerobic training, inspiratory muscle training, and cognitive training in addition to conventional therapy. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.
干预措施: Cognitive training (Other)
Aerobic training + Inspiratory muscle training + Cognitive training + Conventional therapy
Twenty patients will receive a comprehensive intervention program consisting of aerobic training, inspiratory muscle training, and cognitive training in addition to conventional therapy. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.
干预措施: Conventional therapy (Other)
Conventional therapy
Twenty patients will receive conventional therapy only. The intervention will be implemented throughout the hospitalization period and will continue for a minimum duration of three weeks.
干预措施: Conventional therapy (Other)
结局指标
主要结局
Functional Exercise Capacity
时间窗: 3 weeks
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT), a standardized submaximal exercise test that measures the total distance walked on a flat surface within six minutes. The 6MWT reflects the integrated performance of the cardiovascular, respiratory, and musculoskeletal systems and is a clinically meaningful indicator of functional status in patients with acute heart failure.
Peak Oxygen Consumption
时间窗: 3 weeks
Peak oxygen consumption (VO₂ peak) will be estimated using the validated prediction equation developed by Vanhelst et al., which incorporates six-minute walk distance and body mass index. This method provides an indirect assessment of aerobic capacity and cardiorespiratory fitness in patients who are unable to perform maximal exercise testing during hospitalization.
Inspiratory Muscle Strength
时间窗: 3 weeks
Inspiratory muscle strength will be evaluated by measuring maximal inspiratory pressure (MIP or PImax) using a calibrated manometer. This measurement quantifies the maximum static inspiratory pressure generated against an occluded airway and reflects the functional capacity of the inspiratory muscles.
Expiratory Muscle Strength
时间窗: 3 weeks
Expiratory muscle strength will be assessed by measuring maximal expiratory pressure (MEP or PEmax) using a standardized manometer. MEP represents the maximal static pressure produced during forced expiration against an occluded airway and provides an objective measure of global expiratory muscle function.
Cognitive Function
时间窗: 3 weeks
Cognitive function will be assessed using the validated Arabic version of the Montreal Cognitive Assessment (MoCA). This tool evaluates multiple cognitive domains, including attention, memory, executive function, language, and visuospatial abilities, and is suitable for detecting cognitive impairment in patients with acute heart failure.
次要结局
- cardiac troponins(3 weeks)
研究者
Hajar Suleiman Zakaria
Principal investigator
Cairo University