Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oncologic Disorders
- Sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Cardiorespiratory fitness
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cardiorespiratory fitness
Time Frame: Change from baseline to 2 months
VO2peak measured by CPET
Secondary Outcomes
- 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)
- Physical Activity(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)