CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Cardiac Rehabilitation Program +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05132998
NCT05132998N/ACompleted

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

Associacao de Investigacao de Cuidados de Suporte em Oncologia·interventional·Posted Nov 24, 2021·Updated Oct 4, 2022

In Brief

A clinical study evaluating Cardiac Rehabilitation Program and Community exercise intervention for Oncologic Disorders and Cardiovascular Diseases. Completed, enrolled 80 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPortugal

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 24, 2021
Enrollment StartSep 30, 2021
Primary CompletionJun 23, 2022
Study CompletionJul 5, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.6 years ago

Interventions

Cardiac Rehabilitation Programother

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

Community exercise interventionother

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