Assessment of the Effectiveness of Comprehensive Cardiac Rehabilitation and Identification of Factors Modulating Its Results
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Change in Physical Capacity (6MWT)
研究概览
简要总结
Cardiovascular diseases, especially after life-saving surgeries, require comprehensive cardiac rehabilitation (CR). We know that the effectiveness of CR varies among patients. The main goal of this study is to understand which factors-psychological, physical, cognitive, biochemical, and hormonal-influence the success and long-term durability of the recovery process. These findings will help us create more effective and personalized treatment programs.
Who is Being Studied and What is Being Assessed? Study Group: 150 patients of both sexes, aged 50-80 years, hospitalized in the cardiac rehabilitation ward, primarily after Coronary Artery Bypass Grafting (CABG).
Study Period: Patients will be assessed at the start of their hospital stay, at the end of rehabilitation, and again 3-6 months after discharge.
Key Assessment Areas (Modulating Factors)
Physical Status and Fitness:
Exercise tolerance (6-Minute Walk Test).
Muscle strength (handgrip), balance, and gait.
Body composition (analysis of muscle mass and fat tissue).
Respiratory function and diaphragm mobility (ultrasound).
Psychological and Cognitive Factors:
Assessment of anxiety, depression, and general mental well-being.
Evaluation of cognitive functions (memory, concentration) following cardiac surgery.
Sleep Problems (OSA):
Assessment of the risk and severity of Obstructive Sleep Apnea (OSA), which is common in cardiac patients.
Analysis of OSA risk factors related to oral health (dentition, microbiome) and craniofacial structure.
Biological Markers:
Hormonal tests (e.g., testosterone, estradiol) and their correlation with psycho-physical condition and the rehabilitation process.
Analysis of metabolic and muscle-related biomarkers (e.g., myokines: irisin, myostatin).
详细描述
Cardiovascular diseases, particularly advanced coronary artery disease requiring interventions like Coronary Artery Bypass Grafting (CABG), are major global health concerns. Comprehensive cardiac rehabilitation (CR) is a crucial element in patient recovery, yet its effectiveness varies significantly. The main objective of this project is the comprehensive evaluation of the actual effectiveness of standard CR and the identification of multi-faceted factors-biological, functional, and psychosocial-that influence its outcomes and long-term prognosis.
Methodology and Study Design The project plans to recruit 150 male and female patients, aged 50-80 years, who are hospitalized in the cardiac rehabilitation ward, primarily following CABG surgery.
Assessments will be conducted at three key time points to monitor the dynamic nature of changes:
Baseline (T0): At the beginning of cardiac rehabilitation.
Post-Rehab (T1): At the conclusion of the standard rehabilitation program.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 50-80 years
- •Hospitalization in the Cardiac Rehabilitation Ward
- •Undergone coronary artery bypass graft (CABG) surgery within the last 30 days
- •Written, informed consent to participate in the study
排除标准
- •Type II diabetes treated with insulin
- •Neuro-surgical operation in the last 6 months
- •Aneurysms of the cerebral arteries and aorta
- •Recurrent ischemic stroke (Cerebral Vascular Accident)
- •Presence of a pacemaker
- •Current treatment with testosterone
结局指标
主要结局
Change in Physical Capacity (6MWT)
时间窗: Baseline (start of hospitalization/T0) and Post-Rehab (end of cardiac rehabilitation/T1, approximately 3-4 weeks later)
Distance walked in 6 minutes measured in meters using the 6-Minute Walk Test (6MWT). The test reflects objective functional improvement in physical capacity.
次要结局
- Change in Psychological Status (HADS)(Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge)
- Diaphragm Thickness(Baseline and Post-Rehab (approx. 3-4 weeks later).)
- Change in Diaphragm Mobility(Baseline and Post-Rehab (approx. 3-4 weeks later).)
- Change in Montreal Cognitive Assessment (MoCA) Score(Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge).)
- Change in Mini-Mental State Examination (MMSE) Score(Baseline, Post-Rehab (approx. 3-4 weeks later), and Follow-up (3-6 months after discharge).)
研究者
Aleksandra Rył
Clinical Professor
Pomeranian Medical University Szczecin