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NCT Number: NCT06211361

Cardiac Rehabilitation Program in Patients with Cardiovascular Disease

This protocol study aims to evaluate the effectiveness of a cardiac rehabilitation intervention program in patients with cardiovascular diseases to improve both anthropometric and biochemical data, as well as other variables related to cardiovascular disorders (cardiorespiratory fitness, muscle strength, …), and emotional aspects (anxiety, depression).

Additionally, this study aims to evaluate the effectiveness of the cardiac rehabilitation program in improving body composition (waist circumference and body fat percentage), blood pressure and health-related quality of life.

Objectives: i) To assess the functional capacity of patients with a recent cardiovascular event (acute coronary syndrome, onset heart failure, valve or bypass surgery) or with chronic decompensated cardiovascular disease (valvulopathy, pulmonary hypertension, congenital heart disease, heart failure) chronic), ii) to determine the different cardiorespiratory parameters obtained from cardiopulmonary exercise testing (CPET), iii) to determine the lifestyle habits and cardiovascular risk factors, iv) to develop a cardiac rehabilitation program according to and adapted to the need of each of these patients, v) to estimate the effect of the intervention, both in the muscle strength and in post-intervention CPET, biochemical and anthropometric parameters, v) to estimate the effect of the intervention in the quality of life, anxiety, depression, and adherence to the Mediterranean diet.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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

About this study

Methodology: our project is a quantitative study. Patients belonging to the integrated health area of the provinces Cuenca, Toledo, and Albacete will be included. The quantitative study will be a pre-post clinical trial in which at least 80 patients of both genders will be analyzed; who have suffered a coronary event in recent months.

Patients will receive a physical exercise intervention within a cardiac rehabilitation program, lasting 2 months, 3 days per week. The intervention consists of a first part of warm up the large muscle groups, accompanied by breathing exercises (10-15 minutes), followed by a part of strength and muscular resistance training exercises (upper and lower limbs and abdominal muscles), through an exercise table with weights of different weights, depending on the patient's 1RM (maximum repetition), elastic bands of different resistances and weights (15 minutes). Depending on the pathology, a series of special considerations will be taken into account regarding progressive loading (with weights) and resistance, degrees of joint mobility of the upper limbs.

The design of the strength and muscular resistance exercises will be planned taking into account heart rate (HR), cardiovascular pathology, physical capacity of the patient, hemodynamic response at rest, during exercise and after recovery from it, as well as the perception effort and pharmacological action.

Following the recommendations made by the existing literature, we will work the upper limb muscles with a load of 30-40% of the 1RM, with 50-60% of the 1RM being the workload prescribed for lower limb training. Next, we would move on to the aerobic exercise part (continuous and interval), using a treadmill or cycle ergometer, depending on the pathology and the individual characteristics of each patient. The objective we set for ourselves is to increase the duration and intensity progressively until we reach after 45 minutes, after a few weeks. The program would end with a cool-down phase or return to calm.

Study design: This project will have a quantitative design, specifically a pre-post clinical trial.

Patients aged between 20-80 with cardiovascular pathology meeting the inclusion criteria who will be referred from outpatient clinics, hospitalization or primary care and belonging to the provinces of Cuenca, Toledo, and Albacete will be included.

The participants under study will be recruited through their primary care doctor, or cardiologists from the provinces assigned to this project.

The study will be carried out at the "Virgen de la Luz Hospital", in Cuenca, among patients with cardiac pathology described in the inclusion criteria, who will be included in a cardiac rehabilitation program. The variables collected before and after the intervention will be analyzed and studied to assess the adherence of the program and the medium-long term objectives.

The recruitment of participants will be carried out throughout the entire project.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged between 20 and 80 years
  • Having suffered an acute event or presenting chronic cardiovascular pathology with a decrease/limitation of their functional capacity
  • Residing in the provinces of Cuenca, Toledo, or Albacete
  • Desire to participate voluntarily and acceptance of the conditions

Exclusion criteria

  • Have some physical or mental pathology that prevents their participation
  • Inability to adhere to the full program as reported in the initial consultation
  • Being outside the age criteria defined above

Treatment and study plan

Cardiac rehabilitation

Other

Physical exercise intervention within a cardiac rehabilitation program, lasting 2 months, 3 days per week. The intervention consists of a first part of warm up the large muscle groups, accompanied by breathing exercises, followed by a part of strength and muscular resistance training exercises (upper and lower limbs and abdominal muscles), another part of aerobic exercise part (continuous and interval), using a treadmill or cycle ergometer, and finally a part of stretching exercises and a cool-down phase.

Other names: Exercise training program

Primary outcomes

  1. Change in peak oxygen uptake

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  2. Change in cardiorespiratory fitness

    Time frame: Baseline and at the end of the 8weeks intervention

    6 minutes walking test (6MWT)

Secondary outcomes

  1. Change in blood pressure

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured before and after the intervention with the Omron M7 Intelli blood pressure monitor

  2. Change in basal heart rate

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured before and after the intervention after CPET with the Omron M7 Intelli blood pressure monitor.

  3. Change in Maximum heart rate:

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured before and after the intervention after CPET with the Omron M7 Intelli blood pressure monitor

  4. Change in oxygen consumption efficiency slope (OUES)

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  5. Change in Respiratory gas exchange ratio (RER)

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  6. Change in Ventilatory thresholds (VT1 -VT2)

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  7. Change in Heart rate at ventilatory thresholds

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  8. Change in ventilatory equivalents

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  9. Change in partial pressures

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  10. Change in oxygen pulse

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  11. Change in ventilation (VE)

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  12. Change in respiratory reserve (BR)

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  13. Change in muscle efficiency

    Time frame: Baseline and at the end of the 8weeks intervention

    Cardiopulmonary exercise test (CPET)

  14. Change in forced vital capacity (FVC)

    Time frame: Baseline and at the end of the 8weeks intervention

    Using spirometry

  15. Change in forced expired volume in 1 second (FEV1)

    Time frame: Baseline and at the end of the 8weeks intervention

    Using spirometry

  16. Changes in FEV1/FVC

    Time frame: Baseline and at the end of the 8weeks intervention

    Using spirometry

  17. Changes in Maximum Flow 75 (MEF75)(Maximum Flow at 75% of Forced Vital Capacity)

    Time frame: Baseline and at the end of the 8weeks intervention

    Using spirometry

  18. Changes in Maximum Flow 50 (MEF50) (Maximum Flow at 50% of Forced Vital Capacity)

    Time frame: Baseline and at the end of the 8weeks intervention

    Using spirometry

  19. Changes in Maximum Flow 25 (MEF25) (Maximum Flow at 25% of Forced Vital Capacity)

    Time frame: Baseline and at the end of the 8weeks intervention

    Using spirometry

  20. Changes in Peak expiratory flow (PEF)

    Time frame: Baseline and at the end of the 8weeks intervention

    Using spirometry

  21. Changes in tidal volume (VC)

    Time frame: Baseline and at the end of the 8weeks intervention

    Using spirometry

  22. Change in Weight

    Time frame: Baseline and at the end of the 8weeks intervention

    the mean of two measurements (using a OmronBF511 bioimpedance scale) with the participant barefoot and lightly clothed.

  23. Change in Body mass index (BMI)

    Time frame: Baseline and at the end of the 8weeks intervention

    as weight (kg)/height2 (m2)

  24. Change in Waist circumference

    Time frame: Baseline and at the end of the 8weeks intervention

    the mean of three measurements using a flexible tape measure at the midpoint between the last rib and the iliac crest at the end of a normal exhalation.

  25. Change in Hip circumference

    Time frame: Baseline and at the end of the 8weeks intervention

    the mean of three measurements using a flexible tape measure between one and another greater trochanter.

  26. Change in waist hip index

    Time frame: Baseline and at the end of the 8weeks intervention

    as waist circumference (cm)/ hip circumference (cm).

  27. Change in Body fat percentage

    Time frame: Baseline and at the end of the 8weeks intervention

    the mean of two measurements using a OnromBF511 bioimpedance scale.

  28. Change in HbA1c

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured by blood test.

  29. Change in total cholesterol

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured by blood test.

  30. Change in LDL-c cholesterol

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured by blood test.

  31. Change in HDL-c cholesterol

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured by blood test.

  32. Change in triglycerides

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured by blood test.

  33. Change in one repetition maximum (1RM)

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured indirectly by Brzycki´s formula.

  34. Change in handgrip in right arm

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured by CAMRY digital dynamometer.

  35. Change in handgrip in left arm

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured by Camry digital dynamometer.

  36. Change in maximum respiratory pressures

    Time frame: Baseline and at the end of the 8weeks intervention

    Measured by MicroMedical-Carefusion MicroRPM model.

  37. Change in Health-related quality of life

    Time frame: Baseline and at the end of the 8weeks intervention

    36-Item Short Form Survey (SF-36)

  38. Change in Depression and anxiety.

    Time frame: Baseline and at the end of the 8weeks intervention

    Hospital Anxiety and Depression Scale (HADS)

  39. Change in adherence to the Mediterranean diet

    Time frame: Baseline and at the end of the 8weeks intervention

    Predimed questionnaire.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Hospital Virgen de la Luz

Registry information

Official study title

Impact of a Cardiac Rehabilitation Program in Patients with Cardiovascular Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2024
Registry last updated
Sep 19, 2024

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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