Patient-Reported Outcome Measures in Cardiac Rehabilitation: Impact on Health Care

NCT ID: NCT06032013

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-04-01

Brief Summary

Cardiac Rehabilitation (CR) programs are a multidisciplinary process aimed at patient recovery after an acute cardiovascular event or with chronic heart disease, reducing mortality and morbidity, optimising functional capacity and improving quality of life. The aim is to maintain or recover the patient's clinical, physical and psychosocial condition, slowing down or halting the progression of the underlying disease process. It is based on the practice of personalized physical exercise and the adaptation of behaviours towards a healthier lifestyle, ensuring the reduction and control of risk factors. It is considered a cost-effective intervention that is explicitly and formally recommended by the most diverse and important scientific societies. Through the partnership and collaboration between the various health institutions and the academy, the CR program will take place on an outpatient basis, in a supervised manner, starting after risk stratification with a stress test and respective clinical assessment by a cardiologist. The coordinator of the CR program will be a cardiologist, and the entire multidisciplinary team will be responsible for effectiveness and safety, as well as patient assessment and progress.

Detailed Description

The outpatient CR program is designed for a group of participants who have had a cardiac event, based on the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription, consisting of two exercise sessions/week. The sessions are supervised by a healthcare professional specialising in cardiac rehabilitation, and the participant's haemodynamic status is monitored continuously using scales and electronic equipment. PROMs will be applied before and after the program.

Conditions

Quality of Life; Cardiac Rehabilitation; Patient-Reported Outcome Measures; Rehabilitation Exercise

Study Design

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

Study Groups

Cardiac Rehabilitation intervention

Outpatient intervention with participants after a cardiac event who fulfil the inclusion criteria.

Group Type: EXPERIMENTAL

Cardiac rehabilitation program (PROMs)

Intervention Type: OTHER

The program is multidisciplinary with the following components:

• Medical assessment
• Physical training and counselling on physical activity
• Identification and control of risk factors
• Nutritional assessment and counselling
• Psychological assessment and intervention
• Education and information

Interventions

Cardiac rehabilitation program (PROMs)

The program is multidisciplinary with the following components:

• Medical assessment
• Physical training and counselling on physical activity
• Identification and control of risk factors
• Nutritional assessment and counselling
• Psychological assessment and intervention
• Education and information

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult (> 18 years);
• Low-moderate risk for physical exercise;
• After a cardiac event;
• Have signed an informed consent form.

Exclusion Criteria

• Physical or mental limitation to carry out an exercise programme;
• Uncontrolled arrhythmia;
• Severe chronic obstructive pulmonary disease;
• Uncontrolled hypertension;
• Symptomatic peripheral arterial disease;
• Unstable angina;
• Uncontrolled diabetes;
• Acute pulmonary oedema in the last 12 hours;
• Those who refuse to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

José Manuel Afonso Moreira

OTHER

Sponsor Role: lead

Responsible Party

José Manuel Afonso Moreira

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

National School of Public Health

Lisbon, , Portugal

Countries

Portugal

Other Identifiers

National School Public Health

Identifier Type: -

Identifier Source: org_study_id