Clinical trial · Interventional
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Oncologic Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac Rehabilitation Program | Other | — | UNRESOLVED |
| Community exercise intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cardiac Rehabilitation Program (CRP) Group
- description
- 1. Baseline consultation with physiatrist specialized in CRP - addressing CVRF control, comorbidities and disabilities; case-by-case discussion with a cardiologist specialized in CR will be undertaken, for tailoring exercise prescription. Nutritional individualized plan addressing dietary goals. Psychological management addressing psychosocial outcomes and motivation for healthy lifestyle habits 2. Multidisciplinary team educational meeting: periodic group sessions with health education purposes 3. Exercise intervention - 2 times/week sessions at CR facilities, supervised by a physiatrist, conducted by physiotherapist. Heart rate (HR) continuously monitored during each session by remote electrocardiographic monitoring or HR monitor. Exercise intensity estimated according to CR guidelines, determined after CV risk stratification, using CPET results.
- interventionNames
- Other: Cardiac Rehabilitation Program
- type
- ACTIVE_COMPARATOR
- label
- Community Exercise Group
- description
- a) Besides standard medical and supportive care, psychological and nutritional individual support will be offered on demand, in hospital setting, according to the attending physician standard clinical assessment and usual care. Exercise intervention - Performed at a community-based facility, comprising 2 sessions/week, prescribed according to current physical activity guidelines for cancer survivors. Exercise intervention will be conducted by an exercise physiologist, internationally certified in exercise for cancer patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * 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 Exclusion criteria: * 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)
References
Publications (2)
- DERIVEDViamonte SG, Tavares A, Alves AJ, Joaquim A, Vilela E, Capela A, Joao Costa A, Duarte B, Dias Rato N, Afreixo V, Fontes Carvalho R, Santos M, Ribeiro F. Cost-effectiveness analysis of a cardio-oncology rehabilitation framework compared to an exercise intervention for cancer survivors with high cardiovascular risk. Eur J Prev Cardiol. 2026 Mar 13;33(4):566-573. doi: 10.1093/eurjpc/zwae181. PMID 38788778
- DERIVEDViamonte SG, Joaquim AV, Alves AJ, Vilela E, Capela A, Ferreira C, Duarte BF, Rato ND, Teixeira MP, Tavares A, Santos M, Ribeiro F. Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial. JAMA Cardiol. 2023 Dec 1;8(12):1119-1128. doi: 10.1001/jamacardio.2023.3558. PMID 37819656