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| Name | Class |
|---|---|
| Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. | OTHER_GOV |
| University Institute of Maia | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Rehabilitation Program (CRP) Group | Experimental |
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| Community Exercise Group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Rehabilitation Program | Other | In addition to standard medical care, for an 8-week period, patients will have access to the core components of a CRP, delivered by a multidisciplinary rehabilitation team |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness | VO2peak measured by CPET | Change from baseline to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilatory efficiency | minute ventilation to carbon dioxide production slope (VE/VCO2 slope) assessed by CPET | Change from baseline to 2 months |
| Sit-to-stand test | Sit-to-stand test during 60 seconds |
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Inclusion criteria:
Age >18 years
Cancer survivors exposed to the following therapies:
Cancer survivors with medical background of
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:
Active cancer
Considered unsuitable as per principal investigator judgment (namely due to expected inability to fulfill proposed schedule)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Vila Nova de Gaia Espinho, E.P.E. | Vila Nova de Gaia | Porto District | 4434-502 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38788778 | Derived | Viamonte 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. | |
| 37819656 |
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| Community exercise intervention | Other | In addition to standard medical care, for an 8-week period, patients will have access to a community exercise intervention oriented by a sports professional |
|
| Change from baseline to 2 months |
| Handgrip maximal isometric muscle strength | muscle strength measured with manual dynamometers (Kgf) | Change from baseline to 2 months |
| Body composition | Changes in body composition assessed by bioelectrical impedance analysis | Change from baseline to 2 months |
| Resting diastolic blood pressure | Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg) | Change from baseline to 2 months |
| Resting systolic blood pressure | Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg) | Change from baseline to 2 months |
| Resting heart rate | Measured with an average of 3 readings by an automated measurement device (bpm) | Change from baseline to 2 months |
| Hyperlipidemia | Measured through fasting Blood biochemistry including total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density-lipoprotein cholesterol (HDL-C), triglycerides (TG) | Change from baseline to 2 months |
| Diabetes control | Measured through glycated haemoglobin (%) in fasting state | Change from baseline to 2 months |
| Physical Activity | Self-reported through the International Physical Activity Questionnaire, classifying the activity in three categories (low activity levels, moderate activity levels or high activity levels) | Change from baseline to 2 months |
| Physical Activity | objectively assessed by accelerometer, to wear for seven consecutive days | Change from baseline to 2 months |
| Smoking Cessation | Cigarette smoking habits quantified in pack-year and cigarettes per day, to measure exposure to tobacco | Change from baseline to 2 months |
| Depression and anxiety | Psychosocial parameters assessed through the Hospital Anxiety and Depression Score questionnaire. Scores 0-14. A sub-scale score > 8 denotes anxiety or depression symptoms | Change from baseline to 2 months |
| Health Related Quality of Life | Evaluated using the EuroQuol Five- Dimensional questionnaire ( EQ-5D-5L). It consists in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ - Visual Analog Scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. | Change from baseline to 2 months |
| Fatigue | Fatigue score evaluated by the specific item on the EORTC QLQ-C30 questionnaire (high score representing high level of symptomatology) | Change from baseline to 2 months |
| Health Literacy | Assessed by the Newest Vital Sign questionnaire; range score 0-6 (high score corresponding to high health literacy) | Change from baseline to 2 months |
| Inflammatory markers- Interleukin-6 (IL-6) | Blood samples collected to access plasma levels of IL-6 | Change from baseline to 2 months |
| Inflammatory markers - High-sensitivity C-reactive protein | Blood samples collected to access plasma levels of high-sensitivity C-reactive protein | Change from baseline to 2 months |
| Feasibility - Consent rate | number of patients who met inclusion criteria divided by the number who consented in writing to participate. Reasons for not participating in the study will be registered. | Through study recruitment, up to 2 years |
| Testing and Intervention Adverse events | all the events will be recorded and registered as "related" or "unrelated" to the intervention itself, as well as the impact for exercise concerns or other health intervention required | Change from baseline to 2 months |
| Feasibility - Retention rate | number of participants who remained in the study (without formally drop out during intervention). | Change from baseline to 2 months |
| Feasibility - Intervention adherence | total number of exercise sessions attended by participants allocated to this intervention group. Reasons for dropping out will be registered. | Change from baseline to 2 months |
| Feasibility - Completion rate | number of patients that completed all the evaluations during the defined timeline. | Change from baseline to 2 months |
| Cost-effectiveness analysis | Incremental cost per quality-adjusted life. Costs will be calculated from the provider perspective, which includes the costs incurred by the health institution providing health services; and from the societal perspective | From baseline assessment up to 2 years |
| Derived |
| Viamonte 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. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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