Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cardiorespiratory fitness
研究概览
简要总结
Many cancer survivors are at risk for cardiovascular disease (CVD); it is therefore important to identify patients at increased risk for cardiotoxicity, especially in the setting of CVRF or pre-existing CVD, and to design personalized interventions to prevent cardiovascular morbidity. In this background, cardio-oncology rehabilitation frameworks for specific cancer patients have been proposed. Given potential beneficial effects of exercise among cancer patients (including those at higher risk of CVD), data pertaining to optimal program designs are of paramount contemporary importance.
Thus, the aim of this study is to compare the impact of a Cardiac Rehabilitation Program (CRP) model versus a community-based exercise intervention plus usual care on cardiorespiratory fitness (CRF), physical function domains and CVRF control in adult cancer survivors who have been exposed to cardiotoxic cancer treatment and/or with cardiovascular medical background. Study outcomes will be assessed at baseline (M0) and after an 8 weeks-intervention (M1), comprising maximal aerobic capacity (peak oxygen uptake), muscular strength, neuromuscular function, single CVRF control including physical activity measurements and psychosocial parameters, health-related quality of life, fatigue, health literacy, inflammatory response and feasibility metrics; an economic evaluation will provide quantitative comparison, for a cost-effectiveness analysis
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Cancer survivors exposed to the following therapies:
- •high-dose anthracycline or high dose radiotherapy in thoracic wall
- •low-dose anthracycline or anti-human Epidermal growth factor Receptor-type 2 drugs (anti-HER2) alone plus ≥ 2 CVRF and / or age ≥ 60 years at cancer treatment
- •low-dose anthracycline followed by anti-HER2;
- •Cancer survivors with medical background of
- •coronary artery disease
- •moderate valvular disease
- •LVEF <50%
- •Follow up after primary treatment with curative intent
- •Conclusion of primary treatment at least 2 months before the inclusion
排除标准
- •Previous participation in a CRP
- •Contraindications to exercise training:
- •musculoskeletal or neurologic disorders, cognitive impairment
- •unstable angor pectoris, decompensated HF, active myocarditis, acute endocarditis, acute pulmonary thromboembolism, complex ventricular arrhythmias
- •Active cancer
- •Considered unsuitable as per principal investigator judgment (namely due to expected inability to fulfill proposed schedule)
结局指标
主要结局
Cardiorespiratory fitness
时间窗: Change from baseline to 2 months
VO2peak measured by CPET
次要结局
- Ventilatory efficiency(Change from baseline to 2 months)
- Health Literacy(Change from baseline to 2 months)
- Sit-to-stand test(Change from baseline to 2 months)
- Handgrip maximal isometric muscle strength(Change from baseline to 2 months)
- Body composition(Change from baseline to 2 months)
- Diabetes control(Change from baseline to 2 months)
- Depression and anxiety(Change from baseline to 2 months)
- Cost-effectiveness analysis(From baseline assessment up to 2 years)
- Resting diastolic blood pressure(Change from baseline to 2 months)
- Resting systolic blood pressure(Change from baseline to 2 months)
- Resting heart rate(Change from baseline to 2 months)
- Hyperlipidemia(Change from baseline to 2 months)
- Smoking Cessation(Change from baseline to 2 months)
- Fatigue(Change from baseline to 2 months)
- Inflammatory markers- Interleukin-6 (IL-6)(Change from baseline to 2 months)
- Health Related Quality of Life(Change from baseline to 2 months)
- Inflammatory markers - High-sensitivity C-reactive protein(Change from baseline to 2 months)
- Feasibility - Consent rate(Through study recruitment, up to 2 years)
- Testing and Intervention Adverse events(Change from baseline to 2 months)
- Feasibility - Retention rate(Change from baseline to 2 months)
- Feasibility - Intervention adherence(Change from baseline to 2 months)
- Feasibility - Completion rate(Change from baseline to 2 months)
- Physical Activity(Change from baseline to 2 months)