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

Quality of Life Clinical Trial

— PROM_R  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06032013
• Other study ID #: National School Public Health
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: University of Évora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Quality of Life
• Rehabilitation Exercise

Intervention

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

Locations

Country	Name	City	State
Portugal	National School of Public Health	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
José Manuel Afonso Moreira

Country where clinical trial is conducted

Portugal, 

Outcome

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