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Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))TELEREHAB-BRNCT07734831

TELEREHAB-BR: Cardiovascular Rehabilitation Models Trial

A study testing Hybrid Cardiac Telerehabilitation and Traditional Center-Based Cardiac Rehabilitation (TCR) in people with Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) and Chronic Heart Failure, run by University of the State of Santa Catarina at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Introduction: Cardiovascular diseases remain the leading cause of mortality worldwide. Despite the proven effectiveness of cardiac rehabilitation (CR) programs, adherence remains unsatisfactory, especially in public healthcare systems such as the Brazilian Unified Health System (Sistema Único de Saúde - SUS), due to… Read more about this study

Who is it for?
Ages 35 to 80 years
What is being tested?
Hybrid Cardiac Telerehabilitation and Traditional Center-Based Cardiac Rehabilitation (TCR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
1 siteBrazil
Study dates
3 Aug 2026to Jul 2028
Phase
Interventional
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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of coronary artery disease (CAD), including patients with or without acute coronary syndrome (ACS), with or without ST-segment elevation, who were hospitalized for clinical management, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG).
  • Patients with heart failure and left ventricular ejection fraction (LVEF) >20%. New York Heart Association (NYHA) functional class I-III.
  • Clinically stable patients without limiting angina.
  • Patients who meet the study eligibility criteria and provide informed consent to participate.

Who cannot join

  • Decompensated severe heart failure.
  • Unstable angina.
  • Atrial fibrillation with rapid ventricular response.
  • Myocarditis, recent embolism, or thrombophlebitis.
  • Disabling musculoskeletal disorders that preclude participation in the exercise program.
  • History of cardiac arrest with disabling neurological sequelae.
Show all 11Show fewer
  • Any decompensated medical condition that precludes participation in the study.
  • More than 2 months since hospital discharge before screening.
  • No access to the internet via smartphone or computer.
  • Unable to access or use the online intervention platform.
  • Absence of a caregiver or companion available at home during participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil1 site
  • Centro de Ciências da Saúde e do Esporte (CEFID/UDESC)

    Florianópolis, Santa Catarina, 88080-350

    Ariella S Mangia, MSc, PhD(c), 55-48-3664-8643, ariella.mangia@edu.udesc.br

Other trials in Brazil

About this study

Official title: TELEREHAB-BR: A Pragmatic Randomized Controlled Trial Comparing Traditional, Hybrid Cardiac Telerehabilitation, and Usual Care Models of Cardiovascular Rehabilitation

Introduction:

Cardiovascular diseases remain the leading cause of mortality worldwide. Despite the proven effectiveness of cardiac rehabilitation (CR) programs, adherence remains unsatisfactory, especially in public healthcare systems such as the Brazilian Unified Health System (Sistema Único de Saúde - SUS), due to logistical, geographical, and socioeconomic barriers. In this context, cardiac telerehabilitation (CTR) has emerged as a promising alternative, with effectiveness comparable to traditional center-based cardiac rehabilitation.

Read more

However, evidence regarding hybrid cardiac telerehabilitation models applicable to the Brazilian context, using simple and low-cost technologies, remains scarce.

Objectives:

To investigate adherence and its effects on the effectiveness, safety, and maintenance of exercise practice across different models of cardiac rehabilitation, with emphasis on the development and implementation of a hybrid cardiac telerehabilitation (HCTR) model adapted to the Brazilian context.

The primary outcome will be adherence to the exercise program, defined as participation in at least 75% of the proposed sessions during the 12-week intervention.

Secondary outcomes will include estimated cardiorespiratory fitness, functional capacity, functional mobility, handgrip strength, and health-related quality of life.

Adverse events, digital health literacy, exercise maintenance, hospitalizations, and benefits and barriers to exercise will be evaluated as exploratory variables.

Methods:

This is a pragmatic, single-center, three-arm parallel randomized clinical trial consisting of hybrid cardiac telerehabilitation (HCTR), traditional center-based cardiac rehabilitation (TCR), and a usual care (UC) group.

A total of 219 participants with coronary artery disease, with or without acute coronary syndrome, and/or stable heart failure, who are eligible for Phase II cardiac rehabilitation and receiving care through the Brazilian Unified Health System (Sistema Único de Saúde - SUS), will be enrolled.All participants will undergo standardized clinical and functional assessments at baseline, post-intervention, and short-term follow-up.

Clinical screening and exercise stress testing will be performed at the Santa Catarina Institute of Cardiology (Instituto de Cardiologia de Santa Catarina - ICSC), whereas physical assessments and interventions will be conducted at the Center for Cardio-Oncology and Exercise Medicine (Núcleo de Cardio-Oncologia e Medicina do Exercício - NCME), State University of Santa Catarina (UDESC).

The intervention will last 12 weeks, followed by an additional 12-week short-term follow-up period.

Participants allocated to the HCTR group will receive a hybrid intervention consisting of face-to-face sessions, synchronous sessions supervised through videoconferencing, and remotely monitored asynchronous activities.

Participants in the TCR group will participate exclusively in supervised face-to-face sessions, whereas participants in the UC group will receive usual clinical care, including conventional clinical guidance and an educational booklet.

Study Significance:

This clinical trial aims to generate evidence regarding adherence, effectiveness, safety, and maintenance of exercise practice across different models of cardiac rehabilitation. Furthermore, it seeks to provide evidence to support the development and implementation of a hybrid cardiac telerehabilitation model adapted to the Brazilian context and the Brazilian Unified Health System (SUS), contributing to expanding access to cardiac rehabilitation through accessible digital technologies.

Being tested
Hybrid Cardiac Telerehabilitation, Traditional Center-Based Cardiac Rehabilitation (TCR), Usual Care Group
Keywords
Coronary Artery Disease, Heart Failure, Cardiac Rehabilitation, Telerehabilitation, Exercise Therapy, Health Literacy, Exercise Adherence
Medical subject headings
Coronary Artery Disease, Angina Pectoris, Myocardial Infarction, Acute Coronary Syndrome, Heart Failure

What participants receive

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

  • Hybrid Cardiac TelerehabilitationBehavioural

    A 12-week hybrid cardiac telerehabilitation program consisting of three supervised group exercise sessions per week delivered through a hybrid model that combines in-person activities, synchronous exercise sessions via videoconference, and remotely monitored asynchronous activities. Exercise intensity will be individually prescribed based on the results of the baseline exercise stress test. The structured exercise program includes mobility and stretching exercises, light-to-moderate intensity aerobic exercise, and resistance exercises performed using elastic resistance bands. During the synchronous sessions, aerobic exercise will consist of rhythmic activities adapted for the home environment, including stationary marching, light displacement activities, alternating upper- and lower-limb movements, and low-impact functional exercises. During the asynchronous phase, participants will perform guided walking sessions and activities previously provided through instructional videos and educ

  • Traditional Center-Based Cardiac Rehabilitation (TCR)Behavioural

    A 12-week supervised traditional center-based cardiac rehabilitation program consisting of three supervised group exercise sessions per week. Exercise intensity will be individually prescribed based on the results of the baseline exercise stress test. The structured exercise program includes mobility and stretching exercises, aerobic exercise performed primarily on a treadmill or other equipment available at the cardiac rehabilitation center, and resistance exercises performed using elastic resistance bands. The intervention was designed to improve health-related physical fitness, functional capacity, quality of life, and adherence to regular physical exercise in patients eligible for Phase II cardiac rehabilitation.

  • Usual Care GroupBehavioural

    Participants will remain under usual clinical care and will receive standard clinical guidance together with an educational booklet on the safe practice of physical exercise and cardiovascular health care.

Study groups in NCT07734831
Study groupRoleWhat they receive
Hybrid Cardiac Telerehabilitation (HCTR)ExperimentalParticipants assigned to this arm will undergo a 12-week hybrid cardiac telerehabilitation program consisting of in-person sessions, synchronous activities supervised by videoconference, and asynchronous activities remotely monitored, according to the structured exercise protocol developed for this study.
Receives: Behavioral: Hybrid Cardiac Telerehabilitation
Traditional Center-Based Cardiac RehabilitationActive comparatorParticipants assigned to this arm will undergo a 12-week supervised traditional center-based cardiac rehabilitation program at the Center for Cardiology and Exercise Medicine (NCME/UDESC), according to institutional organization and service availability, following the structured exercise protocol developed for this study.
Receives: Behavioral: Traditional Center-Based Cardiac Rehabilitation (TCR)
Usual Care GroupActive comparatorParticipants assigned to this arm will remain under usual clinical care for 12 weeks, receiving standard clinical guidance and an educational booklet on the safe practice of physical exercise developed specifically for this study. The educational booklet is intended to standardize the guidance provided to participants, promote the safe practice of physical exercise, and ensure a minimum level of care throughout the study period. If clinically indicated, participants may be referred to the center-based cardiac rehabilitation program during or after the study period, subject to service availability and the participant's willingness to participate.
Receives: Behavioral: Usual Care Group

What is being measured

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

  1. Adherence to the Exercise Program

    Adherence to the exercise program will be defined as attendance at ≥75% of the prescribed supervised exercise sessions during the 12-week intervention. Adherence will be assessed using attendance records for in-person and synchronous sessions and digital participation records for asynchronous activities, according to the allocated intervention group.

    Measured: During the 12-week intervention period

Secondary outcomes (7)
  1. Peak Metabolic Equivalents (METs)

    Peak exercise capacity will be assessed using the Exercise Stress Test and expressed as the maximum metabolic equivalents (METs) achieved during the test.

    Measured: Baseline, 12 weeks (T1), and 24 weeks (T2)

  2. Estimated Peak Oxygen Uptake (VO₂)

    Cardiorespiratory fitness will be assessed using the Exercise Stress Test and expressed as estimated peak oxygen uptake (VO₂), calculated using standardized prediction equations.

    Measured: Baseline, 12 weeks (T1), and 24 weeks (T2)

  3. Exercise Test Duration

    Exercise capacity will be assessed using the Exercise Stress Test and expressed as the total exercise duration completed during the test.

    Measured: Baseline, 12 weeks (T1), and 24 weeks (T2)

  4. Functional Capacity

    Functional capacity will be assessed using the 1-minute Sit-to-Stand Test, expressed as the total number of repetitions completed within one minute.

    Measured: Baseline, 12 weeks (T1), and 24 weeks (T2)

  5. Functional Mobility

    Functional mobility will be assessed using the Timed Up and Go (TUG) test, expressed as the time required to complete the test in seconds.

    Measured: Baseline, 12 weeks (T1), and 24 weeks (T2)

  6. Handgrip Strength

    Muscle strength will be assessed by handgrip strength using a Jamar hydraulic dynamometer, expressed in kilograms-force (kgf).

    Measured: Baseline, 12 weeks (T1), and 24 weeks (T2)

  7. Health-Related Quality of Life

    Health-related quality of life will be assessed using the EuroQol Five-Dimension Five-Level questionnaire (EQ-5D-5L). The instrument includes a descriptive system comprising five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels ranging from no problems to extreme problems/unable to perform the activity. Responses define a health profile and are not summed into a total score. The questionnaire also includes the EuroQol Visual Analogue Scale (EQ VAS), which ranges from 0 (worst health imaginable) to 100 (best health imaginable). Higher EQ VAS scores indicate better perceived health status.

    Measured: Baseline, 12 weeks (T1), and 24 weeks (T2)

Timeline

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

  1. First posted29 Jul 2026
  2. Study start3 Aug 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionJul 2028 (estimated)

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
219 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07734831
Sponsor's protocol ID
TELEREHAB-BR-RCT
Other IDs
90207725.0.0000.0118
Acronym
TELEREHAB-BR
Status last verified
Jul 2026
First submitted
2 Jul 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Herdy AH, Mangia AS, Benetti M. Cardiovascular Telerehabilitation: An Alternative for Greater Availability of Cardiovascular and Metabolic Rehabilitation in Brazil. Arq Bras Cardiol. 2025 Mar;122(3):e20240570. doi: 10.36660/abc.20240570. English, Portuguese.

    PubMed 40197876

Questions about this trial

What is this clinical trial studying?

A study testing Hybrid Cardiac Telerehabilitation and Traditional Center-Based Cardiac Rehabilitation (TCR) in people with Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)) and Chronic Heart Failure, run by University of the State of Santa Catarina at 1 site in Brazil.

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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 29 Jul 2026. 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 Brazil. 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 Ariella S Mangia, MSc, PhD(c) (55- 48- 3664-8643 ext. 48- 988714049, ariella.mangia@edu.udesc.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to the Exercise Program (time frame: During the 12-week intervention period). 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 NCT07734831, which also lists 1 linked publication.

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 29 Jul 2026.

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