Clinical Trials Directory

Trials / Completed

CompletedNCT05132998

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Associacao de Investigacao de Cuidados de Suporte em Oncologia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
OTHERCardiac Rehabilitation ProgramIn 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 interventionIn addition to standard medical care, for an 8-week period, patients will have access to a community exercise intervention oriented by a sports professional

Timeline

Start date
2021-09-30
Primary completion
2022-06-23
Completion
2022-07-05
First posted
2021-11-24
Last updated
2022-10-04

Locations

1 site across 1 country: Portugal

Source: ClinicalTrials.gov record NCT05132998. Inclusion in this directory is not an endorsement.