Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 192
- 试验地点
- 12
- 主要终点
- Peak VO2
研究概览
简要总结
Cardiovascular-Kidney-Metabolic (CKM) Syndrome is a continuous clinical disease spectrum integrating cardiovascular, renal, and metabolic disorders. Heart failure with preserved ejection fraction (HFpEF) is considered Stage 4 of CKM syndrome, characterized primarily by impairment of cardiac structure and function. Numerous studies have confirmed that exercise intervention is effective in improving metabolic profiles and inflammatory status in Stages 0-3 of CKM syndrome (e.g., obesity, metabolic syndrome, hypertension, and diabetes), and significantly improves clinical outcomes. However, for Stage 4 CKM syndrome, especially in patients with HFpEF, conventional exercise prescription faces significant challenges in balancing safety and efficacy. Moreover, traditional "one-size-fits-all" exercise rehabilitation strategies have failed to significantly improve clinical outcomes due to the lack of individualized precision approaches.
To address this gap, this study proposes to adopt a multicenter, randomized, controlled design, enrolling patients with HFpEF at Stage 4 of CKM syndrome and randomly assigning them to either a personalized high-intensity interval training (HIIT) intervention group or a standard care control group. The **primary endpoint** of this study is the change in peak oxygen consumption (peak VO₂) from baseline after 24 weeks of intervention. In addition, a series of **secondary endpoints** have been established for comprehensive evaluation, including inflammatory biomarkers, cardiac structure and function, quality of life, and composite clinical events. These endpoints aim to comprehensively assess the intervention effects from the perspectives of cardiopulmonary function, metabolism and inflammation, quality of life, and clinical outcomes, as well as to explore the underlying mechanisms.
This study is expected to validate the beneficial effects of personalized exercise on peak VO₂ and various secondary endpoints in patients with Stage 4 CKM syndrome. It will not only provide high-level evidence-based support for exercise therapy in HFpEF but also deepen the understanding of the role of exercise intervention in the full-course management of CKM syndrome, offering key scientific support for the development of precision prevention and treatment strategies across all stages.
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)
盲法说明
Only blinding is maintained for data management personnel, laboratory testing personnel, and data analysts, while not applied to subjects and clinical investigators in the clinical trial.
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 35-70 years;
- •Physical inactivity / sedentary lifestyle defined as:
- •Sedentary behavior: average daily sitting time > 6 hours over the past 6 months; AND/OR Insufficient physical activity: average weekly moderate-intensity physical activity < 150 minutes or vigorous-intensity physical activity < 75 minutes as assessed by the International Physical Activity Questionnaire (IPAQ);
- •Patients with HFpEF at Stage 4 of CKM syndrome who have been clinically stable within the past month (New York Heart Association [NYHA] functional class II-III);
- •Willingness to improve health status through appropriate exercise.
排除标准
- •Presence of contraindications to cardiopulmonary exercise testing (CPET);
- •Positive findings on the exercise electrocardiogram (ECG) during CPET;
- •Diagnosis of psychiatric disorders;
- •Presence of movement disorders or lower extremity exercise-related injuries within the past 6 months;
- •Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
- •Other conditions deemed unsuitable for participation in this study by the investigators;
- •Refusal to sign the informed consent form.
研究组 & 干预措施
Standard care control group
Control group subjects will receive guideline-directed optimal medical therapy (GDMT) , identical to that provided to the intervention group. In addition, they will receive a single, standardized health education session focused on HFpEF and obesity management, covering general recommendations regarding diet, weight management, and regular physical activity. No structured or supervised exercise prescription or program will be offered to the control group.
HIIT intervention group
Subjects in the intervention group will undergo a 24-week personalized high-intensity interval training (HIIT) program, four times per week, with the exercise protocol tailored based on cardiopulmonary exercise testing (CPET). In addition, they will receive guideline-directed healthy lifestyle recommendations and optimal medical therapy (GDMT)
干预措施: High-intensity interval training (Behavioral)
结局指标
主要结局
Peak VO2
时间窗: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Peak VO2 is assessed through CPET, using a maximal graded treadmill test based on the Chinese expert consensus on the standardized clinical application of CPET.
次要结局
- Blood specimen(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Blood specimen(Baseline（week 0），End of study（week 24 ）)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- The New York Heart Association (NYHA) Functional Classification(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Montreal Cognitive Assessment (MoCA)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Hospital Anxiety and Depression Scale (HADS)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- International Physical Activity Questionnaire (IPAQ)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Peak O₂ pulse(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Anaerobic Threshold (AT)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- VE/VCO₂ slope(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- left atrial volume index (LAVI) assessed by echocardiography(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- left atrial volume index (LAVI) assessed by cardiac magnetic resonance(CMR)(Baseline（week 0），End of study（week 24 ）)
- Left ventricular mass index (LVMI) assessed by echocardiography(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Left ventricular mass index (LVMI) assessed by cardiac magnetic resonance(CMR)(Baseline（week 0），End of study（week 24）)
- left atrial volume (LAV)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- left atrial area (LAA)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- left atrial diameter (LAD)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Diastolic function index (E/e' ratio)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Global longitudinal strain (GLS)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Left ventricular myocardial work (MW)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Left atrial strain (LAS)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Epicardial adipose tissue volume (EATV)(Baseline（week 0），End of study（week 24 ）)
- Pericardial adipose tissue volume(Baseline（week 0），End of study（week 24 ）)
- Liver fat content (LFC)(Baseline（week 0），End of study（week 24 ）)
- Liver Stiffness Measurement（LSM）assessed by magnetic resonance elastography (MRE)(Baseline（week 0），End of study（week 24 ）)
- Liver Stiffness Measurement（LSM）assessed by FibroTouch transient elastography(Baseline（week 0），End of study（week 24 ）)
- Visceral adipose tissue area (VATA)(Baseline（week 0），End of study（week 24 ）)
- BMI(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Waist-to-height ratio (WHtR)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Waist-to-hip ratio (WHR)(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- All-Cause Death(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
- Heart failure rehospitalization(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
- Exercise intervention-related adverse events(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
- Clinical deterioration(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
- Fecal specimens(Baseline（week 0），End of study（week 24 ）)
- Liver Stiffness Measurement（LSM）assessed by FibroTouch transient elastography(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
- Fecal specimens(Baseline（week 0），Mid-term（week 12），End of study（week 24 ）)
研究者
Tang Yida
Professor, Vice President of Peking University Third Hospital; Director of Institute of Vascular Medicine, Peking University Third Hospital; Deputy Director, State Key Laboratory of Vascular Homeostasis and Remodeling
Peking University Third Hospital