Cardiac Rehabilitation: Optimisation of the Functional Capacity of Patients Hospitalized With Cardiac Disease

The World Health Organization [WHO] (2021) states that Cardiovascular Diseases [CVD] are the leading cause of death in the world, and in 2019 around 17.9 million deaths were caused by CVD and the national picture is no different. In Portugal, demographic ageing continues to be established by the increase in average life expectancy, which in turn leads to an increase in the percentage of the population with CVDs. Of particular note is Ischemic Heart Disease [IHD], which is the second leading cause of death in Portugal In order to prevent and combat the progression of CVD and its complications, Cardiac Rehabilitation [CR] programs have emerged as a secondary prevention method supported by relevant scientific evidence. In this sense, the Portuguese Society of Cardiology recognizes the role of the Rehabilitation Nurse Specialist as a crucial element of CR teams.

Objective: To evaluate the effectiveness of the phase I cardiac rehabilitation program in patients hospitalized with ischemic heart disease, in terms of functional capacity.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Heart Diseases
• Intervention / Treatment: Procedure: Cardiac Rehabilitation (Phase I) - nurse intervention

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Beja, Portugal
    • Beja

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with Myocardial Ischemia
• Patients who agree to take part in the rehabilitation exercise program
• Patients with the cognitive capacity to understand the instructions given, the exercises to be carried out and the teaching provided
• Patients with clinical and hemodynamic stability
• Patients participating in the rehabilitation exercise program for at least 2 sessions.

Exclusion Criteria:

• Patients who do not meet the safety criteria for exercising after a cardiac event
• Patients with osteoarticular pathology that compromises their ability to exercise.

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: Intervention Group

Procedure: Cardiac Rehabilitation (Phase I) - nurse intervention; The intervention consists of applying CR program (phase I ) following the Guidlines of American Association of Cardiovascular and Pulmonary Rehabilitation. The program was applied by adapting it to the patient, varying the intensity and frequency of the sessions, according to the FITT_VP acronym. This phase consists of functional respiratory rehabilitation and motor rehabilitation exercises. Each session is divided into three parts, starting with a warm-up with breathing and isometric exercises, then the so-called peak, which consists of specific endurance/aerobic exercises, and at the end, as a recovery phase, relaxation exercises with stretching are instructed. Also, health education sessions for patients/caregiver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity intolerance	Modified Borg Dyspnea-It makes it possible to assess the subjective perception of effort and determine safe limits when performing exercises. Esta avaliação permite aos participantes avaliarem-se numa escala de 0 a 10, em que quanto mais baixa for a pontuação, menor será o nível de fadiga.	The evaluation will be carried out in the first session before starting the rehabilitation program (t0), and in every session during the program for an average of 1 week until the end of the program (t1).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	The EuroQol 5 dimensions (EQ-5D-5L), a two-part instrument, was used to assess HRQoL. It includes a descriptive part with five Likert-type scale questions with response levels (from Level 1 "no problems" to Level 5 "extreme problems") for the five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The second part reports a visual analog scale (EQ-VAS), scored by the participant by marking an "x" on the scale numbered from 0 ("worst" HRQoL) to 100 ("best" HRQoL), indicating and measuring current general health.	The evaluation will be carried out in the first session before starting the rehabilitation program (t0). The second evaluation after finishing the program (t1), on average 1 week.
Distance	Monitoring the distance covered by the patient during the walking phase is fundamental for assessing functional capacity after a cardiac event. The service corridor is wide and 30 meters long and 3 meters wide, marked with tapes on the floor every 3 meters. The distance covered in the service corridor during all the training sessions is recorded in meters.	The first evaluation is carried out in the first session before starting the rehabilitation program (t0), and in all the sessions during the program, on average 1 week before the end of the program (t1).

Collaborators and Investigators

• Sponsor: José Manuel Afonso Moreira
• Investigators: Study Chair: José Moreira, MsC, University of Évora

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Phase I; Cardiac Rehabilitation; Myocardial Ischemia; Rehabilitation Nursing
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: Polytechnic Institute of Beja

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The selected patients are informed about the program in full and then asked for their questioned about their willingness to participate and recorded on an informed consent form.

Data collection will be authorized by the participant, following authorization from the Ethics Committee of the Polytechnic Institute of Beja and ULS-Baixo Alentejo.

They will then be anonymized through coding and stored in a cloud with access only to the SR researcher. The results will then be published in a scientific journal.

• IPD Sharing Time Frame: The data will be analyzed at the end of the rehabilitation program, and then shared anonymously through publication in a scientific journal.
• IPD Sharing Access Criteria: Data will only be accessible to researchers associated with the study and will be anonymized, with each participant associated with a coded number.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No