NCT05132998

Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors

Completed NA Last updated 4 October 2022

What this trial tests

NA trial testing Cardiac Rehabilitation Program in Oncologic Disorders in 80 participants. Completed in 5 July 2022.

Timeline

30 September 2021

Primary endpoint
23 June 2022

5 July 2022

Quick facts

Lead sponsor	Associacao de Investigacao de Cuidados de Suporte em Oncologia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	30 September 2021
Primary completion	23 June 2022
Estimated completion	5 July 2022
Sites	1 location across Portugal

Drugs / interventions tested

• Cardiac Rehabilitation Program
• Community exercise intervention

Conditions studied

• Oncologic Disorders — all drugs for Oncologic Disorders →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Who can join

18 and older, any sex, with Oncologic Disorders or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial.
   Viamonte SG, Joaquim AV, Alves AJ, Vilela E, et al · · 2023 · cited 27× · PMID 37819656 · DOI 10.1001/jamacardio.2023.3558
2. Cost-effectiveness analysis of a cardio-oncology rehabilitation framework compared to an exercise intervention for cancer survivors with high cardiovascular risk.
   Viamonte SG, Tavares A, Alves AJ, Joaquim A, et al · · 2026 · cited 7× · PMID 38788778 · DOI 10.1093/eurjpc/zwae181
3. Adherence, safety, and satisfaction of a cardio-oncology rehabilitation program framework versus community exercise training for cancer survivors: findings from the CORE trial.
   Viamonte SG, Joaquim A, Alves A, Vilela E, et al · · 2023 · cited 3× · PMID 36800020 · DOI 10.1007/s00520-023-07638-1
4. Adherence, safety and satisfaction of a cardio-oncology rehabilitation program framework versus community exercise training for cancer survivors: findings from the CORE trial
   Viamonte SG, Joaquim A, Alves A, Vilela E, et al · · 2022 · DOI 10.21203/rs.3.rs-2213384/v1