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NCT Number: NCT07098039

Cardio-Fit2: Impact of a Cardiac Rehabilitation Program in Patients With Cardiovascular Disease

Cardiovascular diseases (CVD) are the main cause of morbidity and mortality in the world, being responsible for 17.9 million deaths annually, according to the World Heart Federation (WHF), which represents a significant social and health cost both due to direct expenses derived from admissions and diagnostic-therapeutic methods, as well as indirect expenses secondary to work incapacity, disability and loss of autonomy that this generates. Although advanced diagnostic and therapeutic techniques have been incorporated in recent years in the acute phase of ischemic heart disease, interventions during hospitalization and after hospital discharge remain insufficient in terms of secondary prevention, a paradoxical fact, since increasingly, the available evidence, as well as the recommendation guidelines, focus on the modification of lifestyle habits and control of cardiovascular risk factors (CVRF), fundamental pillars of cardiac rehabilitation programs (PRC) as a preventive measure both in the appearance of new adverse events and in the reduction of disease progression and improvement of the functional capacity of the patient. Cardiac rehabilitation (CR) was defined by the World Health Organization (WHO) in the 1960s as "the set of activities necessary to ensure that heart patients have an optimal physical, mental and social condition, allowing them to occupy, by their own means, as normal a place as possible in society." The scientific evidence is more than consistent regarding the benefits that multidisciplinary CRP provides in terms of cardiovascular mortality and quality of life (QoL) of our patients and how these results are maintained despite changes in patient characteristics and risk, or the incorporation of new pharmacological treatments. Therefore, if we deprive our patients of these therapies, we are indirectly acting negatively on their cardiovascular prognosis, especially within the field of ischemic heart disease, although it is increasingly being extended to other areas of Cardiology such as heart failure (HF), pulmonary hypertension (PH), valvular disease,7 etc. So much so that it is already included in the latest clinical practice guidelines of the main scientific societies at European and American level, establishing participation in a CR program after acute coronary syndrome or coronary revascularization and those patients with HF as a "level of recommendation I evidence A"

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Virgen de la Luz

Cuenca, 16002, Spain

Location contact

Laura Núñez Martínez cardiology specialist, MsC

CONTACT

[email protected]

680111678

About this study

Currently, due to both the high percentage of patients with cardiovascular disease and the potential increase in sedentary lifestyle, with the geographical dispersion of some territories such as our integrated care area, it is vital to seek effective alternatives so that therapeutic exercise programs are carried out regularly, given that this sedentary attitude can increase the risk of mortality.40 This gives impetus to remote interventions such as telerehabilitation, as a useful paradigm to reduce this risk by being a set of technologies that has facilitated the application, monitoring and follow-up of physical exercise programming.

In today's technological era, the Internet of Things (IoT) paradigm has facilitated the incorporation of connected devices, such as smart tablets, motion sensors, activity trackers, and virtual reality systems, capable of monitoring physiological and behavioral variables in real time and acting on the data collected, thus enabling remote, personalized, and continuous interventions. These advances have begun to be used in healthcare and rehabilitation settings, with promising results.

In this way, an association has been evidenced between the home use of these technologies with moderate to high levels of participation in RCD and patient satisfaction with this modality; 46,47 with similar benefits in improving cardiovascular and psychological health, 48 which suggests that RCD with technological support is a viable option to monitor and even increase participation in the RC process, 46,48 especially for those patients who, due to their employment situation or geographical dispersion, do not have easy access to PRC. It should be taken into account that RCD may entail less medical supervision, control of physical exercise sessions with telemetry and monitoring, security and social interaction, but it is an alternative to achieve maintenance of physical activity levels in patients with CVD. 42 Some authors even recommend RCD in high-risk patients, given that the cardiovascular and psychological benefits that can be obtained by performing low-impact physical exercise at home are greater than the relative risk of an adverse event.

In this regard, several authors have shown that the implementation of home-based training protocols is safe and feasible for patients with low- and moderate-risk CVD; 50-53 with no significant difference in the relative risk of mortality between both CR modalities. 43 Other reviews reached similar conclusions without differentiating between total mortality, exercise capacity and QoL between the RCD and RCT groups. However, there was evidence of marginally higher levels of program completion by home-based participants.

One of the main weaknesses of the RCD is the lack of direct patient monitoring during the program. In this sense, the use of wearable devices overcomes this limitation, as it facilitates remote monitoring of patient activity, increasing accessibility to the RCP for people who would otherwise be unable to benefit from them. Furthermore, the use of these devices during the program contributes to improving adherence by allowing more precise monitoring of both exercise performance and various physiological variables that they record in real time.

The use of wearable devices in RCD programs improves patient adherence and allows for more effective monitoring of physical activity and physiological variables, resulting in greater program effectiveness compared to rehabilitation without remote monitoring.

The study will be conducted at the Virgen de la Luz Hospital in Cuenca, among patients with cardiac pathology described in the inclusion criteria, who will be enrolled in a cardiac rehabilitation program. The variables collected before and after the intervention will be analyzed and studied. Participants will be recruited throughout the project. Variables will be measured initially (inclusion in the program) and after the program ends (post-intervention).

The intervention will last 8 weeks (2 months). Both groups will receive the same exercise program, although the in-person group will attend the hospital 3 days a week for eight weeks, while the hybrid format will consist of 4 in-person sessions (every two weeks) supplemented with a home program until completing 3 sessions of the full program at home. Both groups will be monitored to measure adherence and ensure proper implementation of the program, as well as to adapt and personalize the exercise program and physical activity recommendations at all times. In this way, according to the classification of patients by number of steps (sedentary: < 5000 steps/day, not very active: 5000-7499 steps/day, somewhat active: 7500-9999 steps/day, active: 10000-12499 steps/day and very active: > 12499 steps/day),54 we will set the objective for the patient to be as active as possible, instructing them to try to increase the number of steps gradually, according to the recommendations of the guide for the prescription of physical exercise in patients with cardiovascular risk.

Likewise, patients will be monitored both with hospital telemetry, linked to the Ergoline training program, and with Polar H10 heart rate sensors during in-person sessions (in both groups), for subsequent analysis of electrocardiogram (ECG) signals.

The personalized exercise program for both groups will follow the following structure: warm-up (upper extremity mobilization, lower extremity and spine mobilization, for 10-15 minutes at an intensity of 1-2 on the modified Borg scale), strengthening exercises for large muscle groups (30-40% of 1RM for upper extremities and 50-60% of 1RM for lower extremities), abdominal muscle training, stretching, and relaxation or cool-down.

The program will be implemented with a respiratory muscle training program at 30-70% of the MIP (in the case of the inspiratory muscles) and the MEP (in the case of the expiratory muscles) in those patients whose respiratory pressure measurements have been less than 70% of the predicted value. To manage CVRF, they will receive health education sessions taught by a multidisciplinary team (urology, nursing, cardiology, physiotherapy, etc.). They will be given recommendations for daily physical activity (aerobic exercise) to complete the MIP, at an intensity of 60-85% of VO2 and 60-85% of the maximum heart rate (MHR) obtained by ergospirometry. This basic structure will be adapted for each patient with the goal of personalizing and maximizing the exercise dose (in terms of session duration, intensity, time, and type of exercise, following the FITT principle) based on the patient's progress and the level of physical activity reported by their activity trackers.

At the end of each week, personalized recommendations will be provided based on the analysis of data collected by wearable devices. These recommendations will be generated using adaptive recommendation systems that incorporate deep learning algorithms, allowing us to optimize the benefits of the cardiac rehabilitation program (CRP) and tailor it to each patient's individual needs, in line with the principles of personalized medicine. For patients in whom we also target weight loss as a control for CVRF due to obesity, we will encourage them to work daily at the point of maximum fat oxidation, or fatmax, to maximize the effect of PA on weight loss.

The exercise program will be implemented and reinforced by viewing the materials and videos recorded by the physical therapist, in order to achieve greater adherence to the program.

On the first day of the program, each patient will be given a Fitbit Inspire 3 activity tracker, which will be linked to a data-storage website to monitor each patient's program completion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between the ages of 20 and 80.
  • Have suffered an acute event or have chronic cardiovascular disease with decreased/limited functional capacity.
  • Reside in the provinces of Cuenca, Toledo, or Albacete.
  • Willingness to participate voluntarily and acceptance of the conditions.
  • Must report the ability to access new technologies.

Exclusion criteria

  • Have a physical or mental condition that prevents participation.
  • Inability to adhere to the entire program, as reported in the initial consultation.
  • Are outside the age criteria defined above.

Treatment and study plan

Semi-presential or hybrid group

Other

The hybrid format will consist of 4 in-person sessions (every two weeks) complemented by a home program until completing 3 sessions of the full program at home.

Hospital Cardiac Rehabilitation

Other

The hospital cardiac rehabilitation group will attend the hospital 3 days a week for the same, for eight weeks.

Primary outcomes

  1. Ergospirometry parameters and functional capacity

    Time frame: Baseline and up to eight weeks.

    Ergospirometry will be performed, in which the following parameters will be collected: VO2 peak (ml/Kg/min).

Secondary outcomes

  1. Anthropometric data

    Time frame: Baseline and up to eight weeks

    Weight (Kg)

  2. Heart rate

    Time frame: Baseline and up to eight weeks

    Heart rate will be measured before and after the program.

  3. Dyspnoea

    Time frame: Baseline and up to eight weeks

    The patient's dyspnea, measured using the Modified Borg scale, from 0 (lower value) to 10 (highest value)

  4. Biochemical parameters: HbA1c

    Time frame: Baseline and up to eight weeks

    Pre- and post-intervention tests will be requested: HbA1c

  5. Muscle strength

    Time frame: Baseline and up to eight weeks

    It will be measured with a handgrip dynamometer (left and right) to measure hand grip strength.

  6. Respiratory muscle strength

    Time frame: Baseline and up to eight weeks

    It will be measured by assessing respiratory pressures (maximum inspiratory pressure (MIP)

  7. Nutritional ultrasound 1

    Time frame: Baseline and up to eight weeks

    Ultrasound measurements of the rectus femoris muscle of the quadriceps will be performed to more accurately assess the morphological and functional status of the muscle.

  8. Ultrasound measurements of subcutaneous adipose tissue

    Time frame: Baseline and up to eight weeks

    Ultrasound measurements of subcutaneous adipose tissue will be performed to assess fat distribution and correlate it with clinical variables. The ultrasound transducer is placed on the midline between the xiphoid process and the umbilicus. Images are taken during expiration, in a transverse plane, with a variable 4-10 cm probe, perpendicular to the skin. The image differentiates the superficial and deep layers.

  9. Anxiety

    Time frame: Baseline and up to eight weeks

    It will be measured using the "HADS" scale; it is composed of two subscales: Depression and Anxiety, each with 7 items. The score for each subscale can range from 0 to 21, with each item having 4 response options, ranging from absence/minimal presence = 0 to maximum presence = 3. A higher score indicates greater severity or intensity of symptoms.

  10. Quality of Life Questionnaire (SF-12)

    Time frame: Baseline and up to eight weeks

    Health-related quality of life will be assessed using the SF-12 questionnaire. This is a validated Likert-type tool (a shortened version of the SF-36). The number of response options ranges from three to six, depending on the item, and each question is assigned a score that is subsequently transformed into a scale of 0 to 100.

  11. Pittsburgh Sleep Quality Questionnaire

    Time frame: Baseline and up to eight weeks

    It has a total of 19 questions, grouped into 10 items, each with a score ranging from 0 to 21. "0" indicates ease of falling asleep, and "21" indicates severe difficulty in all areas.

  12. Mediterranean Diet Adherence Questionnaire (PREDIMED)

    Time frame: Baseline and up to eight weeks

    Adherence to the Mediterranean diet will be assessed using the "PREDIMED" questionnaire. This is a validated tool that assesses your level of adherence to the Mediterranean diet pattern with 14 simple questions.

  13. Spirometric parameters: FEV1

    Time frame: Baseline and up to eight weeks

    Ergospirometry will be performed, from which the following respiratory parameters will be obtained: FEV1

  14. Analysis of Photoplethysmography signals

    Time frame: Baseline and up to eight weeks

    Photoplethysmography signals will be analyzed to assess the effect of PRC on cardiac dynamics.

  15. Anthropometric data: height

    Time frame: Baseline and up to eight weeks

    height (cm)

  16. BMI

    Time frame: Baseline and up to eight weeks

    weight and height will be combined to report BMI in kg/m ^2).

  17. Cardiac Rehabilitation Program Satisfaction Questionnaire

    Time frame: up to eight weeks

    A program satisfaction questionnaire will be completed at the end of the program. This questionnaire will assess aspects related to the program, as well as the ease and usefulness of using the wearables and the exercise website and program materials to improve adherence.

  18. Blood pressure

    Time frame: Baseline and up to eight weeks

    pre and post cardiopulmonary exercise test

  19. SpO2

    Time frame: Baseline and up to eight weeks

    oxygen saturation (pre and post CPET)

  20. Biochemical parameters: cholesterol

    Time frame: Baseline and up to eight weeks

    cholesterol

  21. Biochemical parameters: triglycerides

    Time frame: Baseline and up to eight weeks

    triglycerides

  22. Biochemical parameters: pro-BNP

    Time frame: Baseline and up to eight weeks

    pro-BNP

  23. Biochemical parameters: interleukins

    Time frame: Baseline and up to eight weeks

    interleukins

  24. Respiratory muscle strength: PEM

    Time frame: Baseline and up to eight weeks

    It will be measured by assessing respiratory pressure maximum expiratory pressure (MEP)).

  25. Depression

    Time frame: Baseline and up to eight weeks

    It will be measured using the "HADS" scale; it is composed of two subscales: Depression and Anxiety, each with 7 items. The score for each subscale can range from 0 to 21, with each item having 4 response options, ranging from absence/minimal presence = 0 to maximum presence = 3. A higher score indicates greater severity or intensity of symptoms.

  26. Spirometric parameters: FVC

    Time frame: Baseline and up to eight weeks

    Ergospirometry will be performed, from which the following respiratory parameters will be obtained: FVC

  27. Spirometric parameters: FEV1/FVC

    Time frame: Baseline and up to eight weeks

    Ergospirometry will be performed, from which the following respiratory parameters will be obtained: FEV1/FVC

  28. Ultrasound measurements of visceral adipose tissue

    Time frame: Baseline and up to eight weeks

    Ultrasound measurements of visceral adipose tissue will be performed to assess fat distribution and correlate it with clinical variables.

    Visceral adipose tissue (Hamagawa technique) will be measured transversely, in cm. The distance from the edge of the parietal peritoneum to the linea alba on the inner surface at the junction of the two rectus abdominis muscles will be measured.

Study contacts

Contact information is provided by the study sponsor or research team.

Susana Priego Jiménez Physiotherapist, PhD

CONTACT

[email protected]

667855633

Sponsors and collaborators

Lead sponsor

Hospital Virgen de la Luz

Other

Collaborators

  • University of Castilla-La Mancha

Registry information

Acronym: Cardio-Fit2

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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