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

NCT06546878 | Completed

• 1 other identifier: Polytechnic Institute of Beja
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Ischemia; Heart Diseases

Keywords

Cardiac Rehabilitation; Phase I; Myocardial Ischemia; Rehabilitation Nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Health-related quality of life

  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

  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).

Study Arms (1)

Intervention Group

EXPERIMENTAL

Procedure: Cardiac Rehabilitation (Phase I) - nurse intervention

Interventions

Cardiac Rehabilitation (Phase I) - nurse intervention PROCEDURE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• José Manuel Afonso Moreira: lead

Study Sites (1)

Beja

Beja, Portugal

Location

MeSH Terms

Conditions

Myocardial Ischemia; Heart Diseases

Interventions

Cardiac Rehabilitation; Clinical Trials, Phase I as Topic

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• José Moreira, MsC

  University of Évora

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: May 1, 2024
• Primary Completion: July 12, 2024
• Study Completion: July 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data will be analyzed at the end of the rehabilitation program, and then shared anonymously through publication in a scientific journal.
• 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.

Locations

PT (1)