Cardiac Rehabilitation Program in Patients With Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

Official title:

Impact of a Cardiac Rehabilitation Program in Patients With Cardiovascular Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06211361
• Other study ID #: REG: 2023/PI0523
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 8, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: University of Castilla-La Mancha
• Contact: Celia Alvarez-Bueno, PhD
• Phone: 625729642
• Email: celia.alvarezbueno[@]uclm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients aged between 20 and 80 years

2. Having suffered an acute event or presenting chronic cardiovascular pathology with a decrease/limitation of their functional capacity

3. Residing in the provinces of Cuenca, Toledo, or Albacete

4. Desire to participate voluntarily and acceptance of the conditions

Exclusion Criteria:

1. Have some physical or mental pathology that prevents their participation

2. Inability to adhere to the full program as reported in the initial consultation

3. Being outside the age criteria defined above

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Cardiac rehabilitation
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.

Locations

Country	Name	City	State
Spain	Hospital Virgen de la Luz	Cuenca

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Hospital Virgen de la Luz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak oxygen uptake	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Primary	Change in cardiorespiratory fitness	6 minutes walking test (6MWT)	Baseline and at the end of the 8weeks intervention
Secondary	Change in blood pressure	Measured before and after the intervention with the Omron M7 Intelli blood pressure monitor	Baseline and at the end of the 8weeks intervention
Secondary	Change in basal heart rate	Measured before and after the intervention after CPET with the Omron M7 Intelli blood pressure monitor.	Baseline and at the end of the 8weeks intervention
Secondary	Change in Maximum heart rate:	Measured before and after the intervention after CPET with the Omron M7 Intelli blood pressure monitor	Baseline and at the end of the 8weeks intervention
Secondary	Change in oxygen consumption efficiency slope (OUES)	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Secondary	Change in Respiratory gas exchange ratio (RER)	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Secondary	Change in Ventilatory thresholds (VT1 -VT2)	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Secondary	Change in Heart rate at ventilatory thresholds	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Secondary	Change in ventilatory equivalents	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Secondary	Change in partial pressures	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Secondary	Change in oxygen pulse	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Secondary	Change in ventilation (VE)	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Secondary	Change in respiratory reserve (BR)	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Secondary	Change in muscle efficiency	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Secondary	Change in forced vital capacity (FVC)	Using spirometry	Baseline and at the end of the 8weeks intervention
Secondary	Change in forced expired volume in 1 second (FEV1)	Using spirometry	Baseline and at the end of the 8weeks intervention
Secondary	Changes in FEV1/FVC	Using spirometry	Baseline and at the end of the 8weeks intervention
Secondary	Changes in Maximum Flow 75 (MEF75)(Maximum Flow at 75% of Forced Vital Capacity)	Using spirometry	Baseline and at the end of the 8weeks intervention
Secondary	Changes in Maximum Flow 50 (MEF50) (Maximum Flow at 50% of Forced Vital Capacity)	Using spirometry	Baseline and at the end of the 8weeks intervention
Secondary	Changes in Maximum Flow 25 (MEF25) (Maximum Flow at 25% of Forced Vital Capacity)	Using spirometry	Baseline and at the end of the 8weeks intervention
Secondary	Changes in Peak expiratory flow (PEF)	Using spirometry	Baseline and at the end of the 8weeks intervention
Secondary	Changes in tidal volume (VC)	Using spirometry	Baseline and at the end of the 8weeks intervention
Secondary	Change in Weight	the mean of two measurements (using a OmronBF511 bioimpedance scale) with the participant barefoot and lightly clothed.	Baseline and at the end of the 8weeks intervention
Secondary	Change in Body mass index (BMI)	as weight (kg)/height2 (m2)	Baseline and at the end of the 8weeks intervention
Secondary	Change in Waist circumference	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.	Baseline and at the end of the 8weeks intervention
Secondary	Change in Hip circumference	the mean of three measurements using a flexible tape measure between one and another greater trochanter.	Baseline and at the end of the 8weeks intervention
Secondary	Change in waist hip index	as waist circumference (cm)/ hip circumference (cm).	Baseline and at the end of the 8weeks intervention
Secondary	Change in Body fat percentage	the mean of two measurements using a OnromBF511 bioimpedance scale.	Baseline and at the end of the 8weeks intervention
Secondary	Change in HbA1c	Measured by blood test.	Baseline and at the end of the 8weeks intervention
Secondary	Change in total cholesterol	Measured by blood test.	Baseline and at the end of the 8weeks intervention
Secondary	Change in LDL-c cholesterol	Measured by blood test.	Baseline and at the end of the 8weeks intervention
Secondary	Change in HDL-c cholesterol	Measured by blood test.	Baseline and at the end of the 8weeks intervention
Secondary	Change in triglycerides	Measured by blood test.	Baseline and at the end of the 8weeks intervention
Secondary	Change in one repetition maximum (1RM)	Measured indirectly by Brzycki´s formula.	Baseline and at the end of the 8weeks intervention
Secondary	Change in handgrip in right arm	Measured by CAMRY digital dynamometer.	Baseline and at the end of the 8weeks intervention
Secondary	Change in handgrip in left arm	Measured by Camry digital dynamometer.	Baseline and at the end of the 8weeks intervention
Secondary	Change in maximum respiratory pressures	Measured by MicroMedical-Carefusion MicroRPM model.	Baseline and at the end of the 8weeks intervention
Secondary	Change in Health-related quality of life	36-Item Short Form Survey (SF-36)	Baseline and at the end of the 8weeks intervention
Secondary	Change in Depression and anxiety.	Hospital Anxiety and Depression Scale (HADS)	Baseline and at the end of the 8weeks intervention
Secondary	Change in adherence to the Mediterranean diet	Predimed questionnaire.	Baseline and at the end of the 8weeks intervention