Oncologic Disorders, Cardiovascular Diseases
Conditions
Keywords
cardiac rehabilitation, cardio-oncology rehabilitation, exercise training, cardiorespiratory fitness, cardiovascular risk factors
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
Interventions
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
OTHERCommunity exercise intervention
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
Sponsors
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
University Institute of Maia
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory fitness | Change from baseline to 2 months | VO2peak measured by CPET |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sit-to-stand test | Change from baseline to 2 months | Sit-to-stand test during 60 seconds |
| Handgrip maximal isometric muscle strength | Change from baseline to 2 months | muscle strength measured with manual dynamometers (Kgf) |
| Body composition | Change from baseline to 2 months | Changes in body composition assessed by bioelectrical impedance analysis |
| Resting diastolic blood pressure | Change from baseline to 2 months | Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg) |
| Resting systolic blood pressure | Change from baseline to 2 months | Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg) |
| Resting heart rate | Change from baseline to 2 months | Measured with an average of 3 readings by an automated measurement device (bpm) |
| Hyperlipidemia | Change from baseline to 2 months | Measured through fasting Blood biochemistry including total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density-lipoprotein cholesterol (HDL-C), triglycerides (TG) |
| Diabetes control | Change from baseline to 2 months | Measured through glycated haemoglobin (%) in fasting state |
| Physical Activity | Change from baseline to 2 months | Self-reported through the International Physical Activity Questionnaire, classifying the activity in three categories (low activity levels, moderate activity levels or high activity levels) |
| Smoking Cessation | Change from baseline to 2 months | Cigarette smoking habits quantified in pack-year and cigarettes per day, to measure exposure to tobacco |
| Depression and anxiety | Change from baseline to 2 months | Psychosocial parameters assessed through the Hospital Anxiety and Depression Score questionnaire. Scores 0-14. A sub-scale score \> 8 denotes anxiety or depression symptoms |
| Ventilatory efficiency | Change from baseline to 2 months | minute ventilation to carbon dioxide production slope (VE/VCO2 slope) assessed by CPET |
| Fatigue | Change from baseline to 2 months | Fatigue score evaluated by the specific item on the EORTC QLQ-C30 questionnaire (high score representing high level of symptomatology) |
| Health Literacy | Change from baseline to 2 months | Assessed by the Newest Vital Sign questionnaire; range score 0-6 (high score corresponding to high health literacy) |
| Inflammatory markers- Interleukin-6 (IL-6) | Change from baseline to 2 months | Blood samples collected to access plasma levels of IL-6 |
| Inflammatory markers - High-sensitivity C-reactive protein | Change from baseline to 2 months | Blood samples collected to access plasma levels of high-sensitivity C-reactive protein |
| Feasibility - Consent rate | Through study recruitment, up to 2 years | 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. |
| Testing and Intervention Adverse events | Change from baseline to 2 months | 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 |
| Feasibility - Retention rate | Change from baseline to 2 months | number of participants who remained in the study (without formally drop out during intervention). |
| Feasibility - Intervention adherence | Change from baseline to 2 months | total number of exercise sessions attended by participants allocated to this intervention group. Reasons for dropping out will be registered. |
| Feasibility - Completion rate | Change from baseline to 2 months | number of patients that completed all the evaluations during the defined timeline. |
| Cost-effectiveness analysis | From baseline assessment up to 2 years | 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 |
| Health Related Quality of Life | Change from baseline to 2 months | 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'. |
Countries
Portugal
Outcome results
None listed