Cardio-OncologyReCONCT06302634
Cardio-Oncology Rehabilitation Care Process
An observational study of Cardio-Oncology and Rehabilitation, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial summary
The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardio-Oncology, Rehabilitation, Cardiovascular Diseases
- What is being tested?
- Exercise-based cardio-oncology rehabilitation
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jun 2022to 22 Jun 2027
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Women with breast cancer at high risk of developing cardiotoxicity
Who may be able to join
- High risk of cancer treatment-related cardiotoxicity
- Possibility of completing a cardio-onco rehabilitation program (centre-based or home-based) and programmed visits.
- Providing written informed consent.
Who cannot join
- Patients with physical or mental limitation to carry out an exercise program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Carlos Peña-Gil, MD, PhD, +34 981 950 778, carlos.pena.gil@sergas.es
Estíbaliz Díaz-Balboa, +34 981950747, estibaliz.diaz.balboa@sergas.es
About this study
Official title: Hospital-based Cardio-Oncology Rehabilitation Care Process for Cardiovascular Health in Cancer Patients
The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2).
Read the detailed description
Advancements in pharmacological cancer treatment have significantly improved prognosis and increased survival rates. However, the chronicity of treatment-related side effects or associated comorbidities may be exacerbated. Various chemotherapy treatments are associated with the potential development of cardiovascular diseases, such as cardiotoxicity, which stands as a main cause of death among women with early-stage breast cancer. Additionally, other side effects, such as fatigue, loss of muscle mass, insomnia, lymphedema, and cognitive impairments, can markedly decline the quality of life of these patients.
The comprehensive care of oncology patients should extend beyond curative interventions like surgery, radiotherapy, or chemotherapy. It must encompass other aspects, such as psychological support, social support and therapeutic exercise programs to enhance the overall treatment experience and improve the quality of life. Exercise has proven to reduce mortality, morbidity, and the risk of recurrence, improving treatment tolerance and reducing interruptions, thereby promoting adherence. Supervised exercise programs are increasingly recognized as a low-cost and a side-effect-free "polypill". However, they have not yet been integrated into the standard care of patients with cancer.
The inherited experience from multimodal Cardiac Rehabilitation (CR) programs with a comprehensive assessment and a multifaceted intervention with exercise programs as a central component; could be extended to cancer patients, resulting in a CORe program (ReCO in Spanish) by utilizing available CR programs in all healthcare areas.
The proposed CORe care process is grounded in the prior experience with the ONCORE trial (Clinicaltrials.gov: NCT03964142), which has helped in the implementation of new, structured, and controlled healthcare service, ensuring higher quality, safety, and efficiency in healthcare.
The implementation of the CORe program will take place at the University Hospital Complex of Santiago de Compostela (CHUS), under the coordination of the Cardiology, Oncology, and Rehabilitation services. The management of participants data and the establishment of indicators should facilitate the monitoring of the process and the evaluation of the results of clinical interventions.
The goal of this project is to assess the outcomes of a CORe care process through the analysis of health-related indicators, functional capacity, and the quality of life of breast cancer participants attending the Cardio-Oncology Unit.
- Conditions
- Cardio-Oncology, Rehabilitation, Cardiovascular Diseases, Exercise
- Being tested
- Exercise-based cardio-oncology rehabilitation
- Keywords
- cardio-oncology rehabilitation; cardiovascular prevention; exercise; cancer
- Medical subject headings
- Cardiovascular Diseases, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-based cardio-oncology rehabilitationOther
Within the multidisciplinary approach of cardio-oncology rehabilitation, the exercise program will include recommendation and supervision of strength, aerobic and mobility exercises.
| Study group | Role | What they receive |
|---|---|---|
| Center-Based Cardio-Oncology Rehabilitation (CBCORe) | Therapeutic exercise program supervised by a physiotherapist. 2 days/week, duration 1h, in the Cardiac Rehabilitation ward. Receives: Other: Exercise-based cardio-oncology rehabilitation | |
| Home-Based Cardio-Oncology Rehabilitation (HBCORe) | Recommendation of physical exercise and motivational interview through telephone follow-up every 2 weeks by the physiotherapist. Receives: Other: Exercise-based cardio-oncology rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography
Fall of 10 absolute percentage points of left ventricular ejection fraction from baseline or with final value below 53% or global longitudinal strain fall >15% with respect to baseline
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP)
cTnI/T>percentil 99, BNP≥35 pg/mL, NT-proBNP≥125 pg/mL
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Decrease in functional capacity assessed by estimated VO2peak
To estimate VO2peak, the ONCORE equation developed in the following article is used: Díaz-Balboa, E., González-Salvado, V., Rodríguez-Romero, B. et al. Thirty-second sit-to-stand test as an alternative for estimating peak oxygen uptake and 6-min walking distance in women with breast cancer: a cross-sectional study. Support Care Cancer 30, 8251-8260 (2022). https://doi.org/10.1007/s00520-022-07268-z
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors.
Dyslipidemia, Diabetes mellitus, Arterial Hypertension, Smoking status
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Changes in fasting blood glucose
Value of fasting blood glucose (mg/dL) in blood tests
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels
Value of LDL >160 mg/dL or CT> 200 mg/dL in blood tests
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Change in haemoglobin
Value of haemoglobin (g/dL) in blood tests
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Significant cardiovascular and non-cardiovascular adverse effects during treatment.
number of participants with significant cardiovascular and non-cardiovascular adverse effects throughout the study, threatening life, requiring admission, prolonging hospitalization, being clinically relevant or causing chemotherapy interruptions.
Measured: Date of the event throughout the study.
Secondary outcomes (14)
Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire.
Score achieved in the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire, a specific validated scale to assess quality of life of women with breast cancer. It comprises 27 items within 5 areas of assessment: physical well-being (7 items), social and family environment (7 items), emotional well-being (7 items), functional well-being (6 items) and worries related to the diagnosis and treatment of the disease (9 items). Each item is scored by means of a Likert scale from 0 to 5, with higher scores representing better results. The total score is obtained by adding the scores for each item, and ranges from a minimum of 0 (worst possible result) to a maximum of 146 (best possible result).
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test.
Number of repetitions in the sit-to-stand test within 30 seconds.
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in lower limb strength measured by squat dynamometry (kg).
Kilograms by dynamometry.
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in biceps strength by dynamometry (kg).
Kilograms by dynamometry.
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella
Thigh perimeter measured with a tape measure in cm.
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Changes in peak expiratory flow
The peak expiratory flow in units of liters per minute (L/min), measured with a peak flow meter.
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in upper limb strength measured by dynamometry (kg).
Grip strength (both right and left side) and bilateral biceps strength in kilograms by dynamometry.
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in anthropometric parameters: weight in kg.
Weight measured in kg.
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in anthropometric parameters: Body mass index (BMI) in kg/m^2
Weight and height will be combined to report BMI in kg/m^2
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in anthropometric parameters: abdominal circumference in cm.
Abdominal perimeter measured with a tape measure in cm.
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in resting heart rate measured by pulse oximetry (beats per min).
Resting heart rate by pulse oximetry (beats per min).
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in resting blood pressure (mmHg) measured by a blood pressure monitor.
Resting blood pressure by a blood pressure monitor in mmHg.
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ).
Score achieved in the Godin Leisure Test Exercise Questionnaire (GLTEQ) for quantification of physical activity. Activities are classified into three subgroups: "strenuous," "moderate," and "light." The scores corresponding to the energy expenditure (metabolic equivalent (MET)) are obtained by multiplying activities performed for more than 15 min in a week with their coefficients. The numbers represent the MET intensity values (strenuous/ exhausting exercises: 9 METs, moderate exercises: 5 METs, and light exercises: 3 METs).The increasing scores are associated with the increasing number of exercise behaviors, providing references about the contribution of physical activity to health: the activity score of 24 units and more as active (substantial benefits); the activity score of 14-23 units as moderately active (some benefits); and the activity score of 13 units and less as inactive (less substantial or low benefits).
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).
Change in cardiovascular treatment by its presence or absence.
ACE Inhibitor/ARB II; Beta-blocker; Statins; Ezetimibe
Measured: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start22 Jun 2022
- Primary completion22 Jun 2027 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Peña Gil, Hospital Clinico Universitario de Santiago
- Investigators
- Carlos Peña-Gil, MD, PhD, Study director, Hospital Clinico Universitario de SantiagoVioleta González-Salvado, MD, PhD, Study chair, Hospital Clinico Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302634
- Sponsor's protocol ID
- ReCO
- Other IDs
- 2022/137
- Acronym
- ReCO
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Shared in the institutional repository of SERGAS (RUNA), upon request
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-based Cardio-Oncology Rehabilitation Care Process for Cardiovascular Health in Cancer Patients
- ClinicalTrials.gov ID
- NCT06302634
- Acronym / sponsor ID
- ReCO / ReCO
- Conditions
- Cardio-Oncology, Rehabilitation, Cardiovascular Diseases, Exercise
- Keywords
- cardio-oncology rehabilitation; cardiovascular prevention; exercise; cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 22 Jun 2027 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2).
Detailed description
Advancements in pharmacological cancer treatment have significantly improved prognosis and increased survival rates. However, the chronicity of treatment-related side effects or associated comorbidities may be exacerbated. Various chemotherapy treatments are associated with the potential development of cardiovascular diseases, such as cardiotoxicity, which stands as a main cause of death among women with early-stage breast cancer. Additionally, other side effects, such as fatigue, loss of muscle mass, insomnia, lymphedema, and cognitive impairments, can markedly decline the quality of life of these patients.
The comprehensive care of oncology patients should extend beyond curative interventions like surgery, radiotherapy, or chemotherapy. It must encompass other aspects, such as psychological support, social support and therapeutic exercise programs to enhance the overall treatment experience and improve the quality of life. Exercise has proven to reduce mortality, morbidity, and the risk of recurrence, improving treatment tolerance and reducing interruptions, thereby promoting adherence. Supervised exercise programs are increasingly recognized as a low-cost and a side-effect-free "polypill". However, they have not yet been integrated into the standard care of patients with cancer.
The inherited experience from multimodal Cardiac Rehabilitation (CR) programs with a comprehensive assessment and a multifaceted intervention with exercise programs as a central component; could be extended to cancer patients, resulting in a CORe program (ReCO in Spanish) by utilizing available CR programs in all healthcare areas.
The proposed CORe care process is grounded in the prior experience with the ONCORE trial (Clinicaltrials.gov: NCT03964142), which has helped in the implementation of new, structured, and controlled healthcare service, ensuring higher quality, safety, and efficiency in healthcare.
The implementation of the CORe program will take place at the University Hospital Complex of Santiago de Compostela (CHUS), under the coordination of the Cardiology, Oncology, and Rehabilitation services. The management of participants data and the establishment of indicators should facilitate the monitoring of the process and the evaluation of the results of clinical interventions.
The goal of this project is to assess the outcomes of a CORe care process through the analysis of health-related indicators, functional capacity, and the quality of life of breast cancer participants attending the Cardio-Oncology Unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Center-Based Cardio-Oncology Rehabilitation (CBCORe) | – | Other: Exercise-based cardio-oncology rehabilitationTherapeutic exercise program supervised by a physiotherapist. 2 days/week, duration 1h, in the Cardiac Rehabilitation ward. |
| Home-Based Cardio-Oncology Rehabilitation (HBCORe) | – | Other: Exercise-based cardio-oncology rehabilitationRecommendation of physical exercise and motivational interview through telephone follow-up every 2 weeks by the physiotherapist. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with breast cancer at high risk of developing cardiotoxicity
Key inclusion criteria (3 listed)
- High risk of cancer treatment-related cardiotoxicity
- Possibility of completing a cardio-onco rehabilitation program (centre-based or home-based) and programmed visits.
- Providing written informed consent.
Key exclusion criteria (1 listed)
- Patients with physical or mental limitation to carry out an exercise program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise-based cardio-oncology rehabilitationWithin the multidisciplinary approach of cardio-oncology rehabilitation, the exercise program will include recommendation and supervision of strength, aerobic and mobility exercises. | Other | Center-Based Cardio-Oncology Rehabilitation (CBCORe), Home-Based Cardio-Oncology Rehabilitation (HBCORe) |
Primary outcome
Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Fall of 10 absolute percentage points of left ventricular ejection fraction from baseline or with final value below 53% or global longitudinal strain fall >15% with respect to baseline
Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP)
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
cTnI/T>percentil 99, BNP≥35 pg/mL, NT-proBNP≥125 pg/mL
Decrease in functional capacity assessed by estimated VO2peak
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
To estimate VO2peak, the ONCORE equation developed in the following article is used: Díaz-Balboa, E., González-Salvado, V., Rodríguez-Romero, B. et al. Thirty-second sit-to-stand test as an alternative for estimating peak oxygen uptake and 6-min walking distance in women with breast cancer: a cross-sectional study. Support Care Cancer 30, 8251-8260 (2022). https://doi.org/10.1007/s00520-022-07268-z
Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors.
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Dyslipidemia, Diabetes mellitus, Arterial Hypertension, Smoking status
Changes in fasting blood glucose
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Value of fasting blood glucose (mg/dL) in blood tests
Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Value of LDL >160 mg/dL or CT> 200 mg/dL in blood tests
Change in haemoglobin
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years
Value of haemoglobin (g/dL) in blood tests
Significant cardiovascular and non-cardiovascular adverse effects during treatment.
Time frame: Date of the event throughout the study.
number of participants with significant cardiovascular and non-cardiovascular adverse effects throughout the study, threatening life, requiring admission, prolonging hospitalization, being clinically relevant or causing chemotherapy interruptions.
14 secondary outcomes
Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire.
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test.
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in lower limb strength measured by squat dynamometry (kg).
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in biceps strength by dynamometry (kg).
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Changes in peak expiratory flow
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in upper limb strength measured by dynamometry (kg).
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in anthropometric parameters: weight in kg.
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in anthropometric parameters: Body mass index (BMI) in kg/m^2
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in anthropometric parameters: abdominal circumference in cm.
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in resting heart rate measured by pulse oximetry (beats per min).
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in resting blood pressure (mmHg) measured by a blood pressure monitor.
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2)
Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ).
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).
Change in cardiovascular treatment by its presence or absence.
Time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided. Shared in the institutional repository of SERGAS (RUNA), upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Peña-Gil, MD, PhD study director
Hospital Clinico Universitario de Santiago
Violeta González-Salvado, MD, PhD study chair
Hospital Clinico Universitario de Santiago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio-Oncology and Rehabilitation, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Estíbaliz Díaz-Balboa, PT (+34 981950747, estibaliz.diaz.balboa@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography (time frame: Baseline (T0); 3 months after completing the exercise program (T1); follow-up at 9 months from baseline (T2); every year after study completion up to a maximum of 5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.