Cardiac Rehabilitation Program in Patients with Cardiovascular Disease

NCT ID: NCT06211361

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2024-10-30

Brief 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.

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Participants will be included in a cardiac rehabilitation program.

Group Type: EXPERIMENTAL

Cardiac rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Exercise training program

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Virgen de la Luz

OTHER

Sponsor Role: collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susana Priego-Jiménez, MsC

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Luz

Laura Núñez-Martínez, MsC

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Luz

Locations

Hospital Virgen de la Luz

Cuenca, Cuenca, Spain

Countries

Spain

Other Identifiers

REG: 2023/PI0523

Identifier Type: -

Identifier Source: org_study_id