Clinical trial NCT05132998: Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
Official title: Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncologic Disorders
Cardiovascular Diseases
Keywords: cardiac rehabilitation
cardio-oncology rehabilitation
exercise training
cardiorespiratory fitness
cardiovascular risk factors
Lead sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
name: University Institute of Maia
First posted: 2021-11-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Change from baseline to 2 months
Secondary outcomes:
measure: Ventilatory efficiency
timeFrame: Change from baseline to 2 months
measure: Sit-to-stand test
timeFrame: Change from baseline to 2 months
measure: Handgrip maximal isometric muscle strength
timeFrame: Change from baseline to 2 months
measure: Body composition
timeFrame: Change from baseline to 2 months
measure: Resting diastolic blood pressure
timeFrame: Change from baseline to 2 months
measure: Resting systolic blood pressure
timeFrame: Change from baseline to 2 months
measure: Resting heart rate
timeFrame: Change from baseline to 2 months
measure: Hyperlipidemia
timeFrame: Change from baseline to 2 months
measure: Diabetes control
timeFrame: Change from baseline to 2 months
measure: Physical Activity
timeFrame: Change from baseline to 2 months
measure: Physical Activity
timeFrame: Change from baseline to 2 months
measure: Smoking Cessation
timeFrame: Change from baseline to 2 months
measure: Depression and anxiety
timeFrame: Change from baseline to 2 months
measure: Health Related Quality of Life
timeFrame: Change from baseline to 2 months
measure: Fatigue
timeFrame: Change from baseline to 2 months
measure: Health Literacy
timeFrame: Change from baseline to 2 months
measure: Inflammatory markers- Interleukin-6 (IL-6)
timeFrame: Change from baseline to 2 months
measure: Inflammatory markers - High-sensitivity C-reactive protein
timeFrame: Change from baseline to 2 months
measure: Feasibility - Consent rate
timeFrame: Through study recruitment, up to 2 years
measure: Testing and Intervention Adverse events
timeFrame: Change from baseline to 2 months
measure: Feasibility - Retention rate
timeFrame: Change from baseline to 2 months
measure: Feasibility - Intervention adherence
timeFrame: Change from baseline to 2 months
measure: Feasibility - Completion rate
timeFrame: Change from baseline to 2 months
measure: Cost-effectiveness analysis
timeFrame: From baseline assessment up to 2 years
Other outcomes:
Locations:
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia Espinho, E.P.E.
state: Porto
Study officials:
References: