Cardiac Rehabilitation Program in Patients with Cardiovascular Disease

NCT06211361 | Active Not Recruiting DMC

• 1 other identifier: REG: 2023/PI0523
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

cardiovascular diseases; heart failure; ischemic heart disease; cardiac rehabilitation; exercise training; cardiopulmonary exercise test; oxygen uptake

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (39)

• Change in blood pressure

  Baseline and at the end of the 8weeks intervention

• Change in basal heart rate

  Baseline and at the end of the 8weeks intervention

• Change in Maximum heart rate:

  Baseline and at the end of the 8weeks intervention

• Change in oxygen consumption efficiency slope (OUES)

  Baseline and at the end of the 8weeks intervention

• Change in Respiratory gas exchange ratio (RER)

  Baseline and at the end of the 8weeks intervention

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will be included in a cardiac rehabilitation program.

Other: Cardiac rehabilitation

Interventions

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.

Also known as: Exercise training program

Intervention

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Hospital Virgen de la Luz: collaborator

Study Sites (1)

Hospital Virgen de la Luz

Cuenca, Cuenca, 16002, Spain

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure; Myocardial Ischemia

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Susana Priego-Jiménez, MsC

  Hospital Virgen de la Luz

  PRINCIPAL INVESTIGATOR

• Laura Núñez-Martínez, MsC

  Hospital Virgen de la Luz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Our project is a quantitative study

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: July 10, 2024
• Primary Completion: July 30, 2024
• Study Completion: October 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

ES (1)