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Oncologic DisordersNCT05132998

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

A study testing Cardiac Rehabilitation Program and Community exercise intervention in people with Oncologic Disorders and Cardiovascular Diseases, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oncologic Disorders, Cardiovascular Diseases
What is being tested?
Cardiac Rehabilitation Program and Community exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 sitePortugal
Study dates
30 Sep 2021to 5 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Centro Hospitalar Vila Nova de Gaia Espinho, E.P.E.

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

About this study

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

Being tested
Cardiac Rehabilitation Program, Community exercise intervention
Keywords
cardiac rehabilitation, cardio-oncology rehabilitation, exercise training, cardiorespiratory fitness, cardiovascular risk factors
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05132998
Study groupRoleWhat they receive
Cardiac Rehabilitation Program (CRP) GroupExperimental1. Baseline consultation with physiatrist specialized in CRP - addressing CVRF control, comorbidities and disabilities; case-by-case discussion with a cardiologist specialized in CR will be undertaken, for tailoring exercise prescription. Nutritional individualized plan addressing dietary goals. Psychological management addressing psychosocial outcomes and motivation for healthy lifestyle habits 2. Multidisciplinary team educational meeting: periodic group sessions with health education purposes 3. Exercise intervention - 2 times/week sessions at CR facilities, supervised by a physiatrist, conducted by physiotherapist. Heart rate (HR) continuously monitored during each session by remote electrocardiographic monitoring or HR monitor. Exercise intensity estimated according to CR guidelines, determined after CV risk stratification, using CPET results.
Receives: Other: Cardiac Rehabilitation Program
Community Exercise GroupActive comparatora) Besides standard medical and supportive care, psychological and nutritional individual support will be offered on demand, in hospital setting, according to the attending physician standard clinical assessment and usual care. Exercise intervention - Performed at a community-based facility, comprising 2 sessions/week, prescribed according to current physical activity guidelines for cancer survivors. Exercise intervention will be conducted by an exercise physiologist, internationally certified in exercise for cancer patients
Receives: Other: Community exercise intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiorespiratory fitness

    VO2peak measured by CPET

    Measured: Change from baseline to 2 months

Secondary outcomes (24)

  1. Ventilatory efficiency

    minute ventilation to carbon dioxide production slope (VE/VCO2 slope) assessed by CPET

    Measured: Change from baseline to 2 months

  2. Sit-to-stand test

    Sit-to-stand test during 60 seconds

    Measured: Change from baseline to 2 months

  3. Handgrip maximal isometric muscle strength

    muscle strength measured with manual dynamometers (Kgf)

    Measured: Change from baseline to 2 months

  4. Body composition

    Changes in body composition assessed by bioelectrical impedance analysis

    Measured: Change from baseline to 2 months

  5. Resting diastolic blood pressure

    Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)

    Measured: Change from baseline to 2 months

  6. Resting systolic blood pressure

    Measured with an average of 3 readings by an automated measurement device as per the ESC guidelines (mmHg)

    Measured: Change from baseline to 2 months

  7. Resting heart rate

    Measured with an average of 3 readings by an automated measurement device (bpm)

    Measured: Change from baseline to 2 months

  8. Hyperlipidemia

    Measured through fasting Blood biochemistry including total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high-density-lipoprotein cholesterol (HDL-C), triglycerides (TG)

    Measured: Change from baseline to 2 months

  9. Diabetes control

    Measured through glycated haemoglobin (%) in fasting state

    Measured: Change from baseline to 2 months

  10. Physical Activity

    Self-reported through the International Physical Activity Questionnaire, classifying the activity in three categories (low activity levels, moderate activity levels or high activity levels)

    Measured: Change from baseline to 2 months

  11. Physical Activity

    objectively assessed by accelerometer, to wear for seven consecutive days

    Measured: Change from baseline to 2 months

  12. Smoking Cessation

    Cigarette smoking habits quantified in pack-year and cigarettes per day, to measure exposure to tobacco

    Measured: Change from baseline to 2 months

  13. Depression and anxiety

    Psychosocial parameters assessed through the Hospital Anxiety and Depression Score questionnaire. Scores 0-14. A sub-scale score > 8 denotes anxiety or depression symptoms

    Measured: Change from baseline to 2 months

  14. Health Related Quality of Life

    Evaluated using the EuroQuol Five- Dimensional questionnaire ( EQ-5D-5L). It consists in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ - Visual Analog Scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

    Measured: Change from baseline to 2 months

  15. Fatigue

    Fatigue score evaluated by the specific item on the EORTC QLQ-C30 questionnaire (high score representing high level of symptomatology)

    Measured: Change from baseline to 2 months

  16. Health Literacy

    Assessed by the Newest Vital Sign questionnaire; range score 0-6 (high score corresponding to high health literacy)

    Measured: Change from baseline to 2 months

  17. Inflammatory markers- Interleukin-6 (IL-6)

    Blood samples collected to access plasma levels of IL-6

    Measured: Change from baseline to 2 months

  18. Inflammatory markers - High-sensitivity C-reactive protein

    Blood samples collected to access plasma levels of high-sensitivity C-reactive protein

    Measured: Change from baseline to 2 months

  19. Feasibility - Consent rate

    number of patients who met inclusion criteria divided by the number who consented in writing to participate. Reasons for not participating in the study will be registered.

    Measured: Through study recruitment, up to 2 years

  20. Testing and Intervention Adverse events

    all the events will be recorded and registered as "related" or "unrelated" to the intervention itself, as well as the impact for exercise concerns or other health intervention required

    Measured: Change from baseline to 2 months

  21. Feasibility - Retention rate

    number of participants who remained in the study (without formally drop out during intervention).

    Measured: Change from baseline to 2 months

  22. Feasibility - Intervention adherence

    total number of exercise sessions attended by participants allocated to this intervention group. Reasons for dropping out will be registered.

    Measured: Change from baseline to 2 months

  23. Feasibility - Completion rate

    number of patients that completed all the evaluations during the defined timeline.

    Measured: Change from baseline to 2 months

  24. Cost-effectiveness analysis

    Incremental cost per quality-adjusted life. Costs will be calculated from the provider perspective, which includes the costs incurred by the health institution providing health services; and from the societal perspective

    Measured: From baseline assessment up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start30 Sep 2021
  3. Primary completion23 Jun 2022
  4. Study completion5 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05132998
Sponsor's protocol ID
CORE Trial
Status last verified
Oct 2022
First submitted
27 Sep 2021
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Viamonte SG, Tavares A, Alves AJ, Joaquim A, Vilela E, Capela A, Joao Costa A, Duarte B, Dias Rato N, Afreixo V, Fontes Carvalho R, Santos M, Ribeiro F. Cost-effectiveness analysis of a cardio-oncology rehabilitation framework compared to an exercise intervention for cancer survivors with high cardiovascular risk. Eur J Prev Cardiol. 2026 Mar 13;33(4):566-573. doi: 10.1093/eurjpc/zwae181.

    PubMed 38788778

  • Viamonte SG, Joaquim AV, Alves AJ, Vilela E, Capela A, Ferreira C, Duarte BF, Rato ND, Teixeira MP, Tavares A, Santos M, Ribeiro F. Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial. JAMA Cardiol. 2023 Dec 1;8(12):1119-1128. doi: 10.1001/jamacardio.2023.3558.

    PubMed 37819656

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac Rehabilitation Program and Community exercise intervention in people with Oncologic Disorders and Cardiovascular Diseases, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 1 site in Portugal.

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 11 inclusion and 6 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: finished, as of the sponsor's last update on 4 Oct 2022. 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 Portugal. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiorespiratory fitness (time frame: Change from baseline to 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05132998, which also lists 2 linked publications.

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 4 Oct 2022.

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