Clinical trial NCT06211361: Cardiac Rehabilitation Program in Patients with Cardiovascular Disease
Official title: Impact of a Cardiac Rehabilitation Program in Patients with Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: cardiovascular diseases
heart failure
ischemic heart disease
cardiac rehabilitation
exercise training
cardiopulmonary exercise test
oxygen uptake
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Hospital Virgen de la Luz
First posted: 2024-01-18
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Our project is a quantitative study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in peak oxygen uptake
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in cardiorespiratory fitness
timeFrame: Baseline and at the end of the 8weeks intervention
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in basal heart rate
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Maximum heart rate:
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in oxygen consumption efficiency slope (OUES)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Respiratory gas exchange ratio (RER)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Ventilatory thresholds (VT1 -VT2)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Heart rate at ventilatory thresholds
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in ventilatory equivalents
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in partial pressures
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in oxygen pulse
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in ventilation (VE)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in respiratory reserve (BR)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in muscle efficiency
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in forced vital capacity (FVC)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in forced expired volume in 1 second (FEV1)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Changes in FEV1/FVC
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Changes in Maximum Flow 75 (MEF75)(Maximum Flow at 75% of Forced Vital Capacity)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Changes in Maximum Flow 50 (MEF50) (Maximum Flow at 50% of Forced Vital Capacity)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Changes in Maximum Flow 25 (MEF25) (Maximum Flow at 25% of Forced Vital Capacity)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Changes in Peak expiratory flow (PEF)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Changes in tidal volume (VC)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Weight
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Body mass index (BMI)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Waist circumference
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Hip circumference
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in waist hip index
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Body fat percentage
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in HbA1c
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in total cholesterol
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in LDL-c cholesterol
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in HDL-c cholesterol
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in triglycerides
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in one repetition maximum (1RM)
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in handgrip in right arm
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in handgrip in left arm
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in maximum respiratory pressures
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Health-related quality of life
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in Depression and anxiety.
timeFrame: Baseline and at the end of the 8weeks intervention
measure: Change in adherence to the Mediterranean diet
timeFrame: Baseline and at the end of the 8weeks intervention
Other outcomes:
Locations:
city: Cuenca
country: Spain
facility: Hospital Virgen de la Luz
Study officials:
affiliation: Hospital Virgen de la Luz
name: Susana Priego-Jiménez, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Luz
name: Laura Núñez-Martínez, MsC
role: PRINCIPAL_INVESTIGATOR
References: