Cardiac Rehabilitation Program in Patients with Cardiovascular Disease

Impact of a 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Cardiac rehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cuenca, Spain, 16002
    • Hospital Virgen de la Luz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Participants will be included in a cardiac rehabilitation program.

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.; Other Names: Exercise training program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peak oxygen uptake	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in cardiorespiratory fitness	6 minutes walking test (6MWT)	Baseline and at the end of the 8weeks intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oxygen consumption efficiency slope (OUES)	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in Respiratory gas exchange ratio (RER)	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in Ventilatory thresholds (VT1 -VT2)	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in Heart rate at ventilatory thresholds	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in ventilatory equivalents	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in partial pressures	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in oxygen pulse	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in ventilation (VE)	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in respiratory reserve (BR)	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in muscle efficiency	Cardiopulmonary exercise test (CPET)	Baseline and at the end of the 8weeks intervention
Change in forced vital capacity (FVC)	Using spirometry	Baseline and at the end of the 8weeks intervention
Change in forced expired volume in 1 second (FEV1)	Using spirometry	Baseline and at the end of the 8weeks intervention
Changes in FEV1/FVC	Using spirometry	Baseline and at the end of the 8weeks intervention
Changes in Peak expiratory flow (PEF)	Using spirometry	Baseline and at the end of the 8weeks intervention
Changes in tidal volume (VC)	Using spirometry	Baseline and at the end of the 8weeks intervention
Change in Body mass index (BMI)	as weight (kg)/height2 (m2)	Baseline and at the end of the 8weeks intervention
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
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
Change in waist hip index	as waist circumference (cm)/ hip circumference (cm).	Baseline and at the end of the 8weeks intervention
Change in HbA1c	Measured by blood test.	Baseline and at the end of the 8weeks intervention
Change in total cholesterol	Measured by blood test.	Baseline and at the end of the 8weeks intervention
Change in LDL-c cholesterol	Measured by blood test.	Baseline and at the end of the 8weeks intervention
Change in HDL-c cholesterol	Measured by blood test.	Baseline and at the end of the 8weeks intervention
Change in triglycerides	Measured by blood test.	Baseline and at the end of the 8weeks intervention
Change in one repetition maximum (1RM)	Measured indirectly by Brzycki´s formula.	Baseline and at the end of the 8weeks intervention
Change in handgrip in right arm	Measured by CAMRY digital dynamometer.	Baseline and at the end of the 8weeks intervention
Change in Depression and anxiety.	Hospital Anxiety and Depression Scale (HADS)	Baseline and at the end of the 8weeks intervention
Change in adherence to the Mediterranean diet	Predimed questionnaire.	Baseline and at the end of the 8weeks intervention
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
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
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
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
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
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
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
Change in Body fat percentage	the mean of two measurements using a OnromBF511 bioimpedance scale.	Baseline and at the end of the 8weeks intervention
Change in handgrip in left arm	Measured by Camry digital dynamometer.	Baseline and at the end of the 8weeks intervention
Change in maximum respiratory pressures	Measured by MicroMedical-Carefusion MicroRPM model.	Baseline and at the end of the 8weeks intervention
Change in Health-related quality of life	36-Item Short Form Survey (SF-36)	Baseline and at the end of the 8weeks intervention

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Hospital Virgen de la Luz
• Investigators: Principal Investigator: Susana Priego-Jiménez, MsC, Hospital Virgen de la Luz; Principal Investigator: Laura Núñez-Martínez, MsC, Hospital Virgen de la Luz

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): July 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: ischemic heart disease; cardiovascular diseases; heart failure; exercise training; oxygen uptake; cardiopulmonary exercise test; cardiac rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: REG: 2023/PI0523

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No