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

Patient-Reported Outcome Measures and Quality of Life in Cardiac Rehabilitation: Impact on Health Care

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Cardiac Rehabilitation; Rehabilitation Exercise; Patient-Reported Outcome Measures
• Intervention / Treatment: Other: Cardiac rehabilitation program (PROMs)

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal
    • National School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Rehabilitation intervention; Outpatient intervention with participants after a cardiac event who fulfil the inclusion criteria.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D-5L: Health-related quality of life	The EQ5D makes it possible to assess quality of life in a given pathology in the general population, presented in different domains. The visual analogue scale of this questionnaire has a score of 0-100. Higher scores mean a better result.	Before the intervention and up to 8 weeks.
HADS: Anxiety and depression	Participants' anxiety and worries are also assessed. Mood disorders, weakness, worry, stress, and depression are common psychological repercussions for patients after a cardiac event, which can trigger hyperventilation reactions. This type of common reaction to emotional extremes such as fear, anxiety, or stress in participants can have a direct impact on involvement in CR programs. This questionnaire is made up of 14 questions. Lower scores mean a better result.	Before the intervention and up to 8 weeks.
BREQ-2: Behavioural Regulations in Exercise Questionnaire	Assessment of the different aspects of motivational regulation for exercise. It is a questionnaire that evaluates and represents the differences in the ways in which people's behaviour can be regulated and how these differences are experienced.	Before the intervention and up to 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate (bpm)	Before, during and up to 8 weeks of the program.
Blood pressure	Blood pressure (mmHg)	Before, during and up to 8 weeks of the program.
Peripheral oxygen saturation	Peripheral oxygen saturation (%)	Before, during and up to 8 weeks of the program.
Exercise Capacity	Borg scale- score 0-10. Higher values mean greater respiratory effort.	During and up to 8 weeks of the program.
Weight	Weight (Kg)	Before the intervention and up to 8 weeks.
Abdominal perimeter	Abdominal perimeter (cm)	Before the intervention and up to 8 weeks.

Collaborators and Investigators

• Sponsor: José Manuel Afonso Moreira

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: National School Public Health

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No