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

July 30, 2024 updated by: José Manuel Afonso Moreira

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
EQ5D-5L: Health-related quality of life
Time Frame: Before the intervention and up to 8 weeks.
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
Time Frame: Before the intervention and up to 8 weeks.
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
Time Frame: Before the intervention and up to 8 weeks.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: Before, during and up to 8 weeks of the program.
Heart rate (bpm)
Before, during and up to 8 weeks of the program.
Blood pressure
Time Frame: Before, during and up to 8 weeks of the program.
Blood pressure (mmHg)
Before, during and up to 8 weeks of the program.
Peripheral oxygen saturation
Time Frame: Before, during and up to 8 weeks of the program.
Peripheral oxygen saturation (%)
Before, during and up to 8 weeks of the program.
Exercise Capacity
Time Frame: During and up to 8 weeks of the program.
Borg scale- score 0-10. Higher values mean greater respiratory effort.
During and up to 8 weeks of the program.
Weight
Time Frame: Before the intervention and up to 8 weeks.
Weight (Kg)
Before the intervention and up to 8 weeks.
Abdominal perimeter
Time Frame: Before the intervention and up to 8 weeks.
Abdominal perimeter (cm)
Before the intervention and up to 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
José Manuel Afonso Moreira

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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