Clinical trial NCT06032013: Patient-Reported Outcome Measures in Cardiac Rehabilitation: Impact on Health Care
Official title: Patient-Reported Outcome Measures and Quality of Life in Cardiac Rehabilitation: Impact on Health Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Quality of Life
Cardiac Rehabilitation
Patient-Reported Outcome Measures
Rehabilitation Exercise
Lead sponsor: University of Évora
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: EQ5D-5L: Health-related quality of life
timeFrame: Before the intervention and up to 8 weeks.
measure: HADS: Anxiety and depression
timeFrame: Before the intervention and up to 8 weeks.
measure: BREQ-2: Behavioural Regulations in Exercise Questionnaire
timeFrame: Before the intervention and up to 8 weeks.
Secondary outcomes:
measure: Heart rate
timeFrame: Before, during and up to 8 weeks of the program.
measure: Blood pressure
timeFrame: Before, during and up to 8 weeks of the program.
measure: Peripheral oxygen saturation
timeFrame: Before, during and up to 8 weeks of the program.
measure: Exercise Capacity
timeFrame: During and up to 8 weeks of the program.
measure: Weight
timeFrame: Before the intervention and up to 8 weeks.
measure: Abdominal perimeter
timeFrame: Before the intervention and up to 8 weeks.
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: National School of Public Health
Study officials:
References: