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Completed

NCT Number: NCT06546878

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beja

Beja, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Activity intolerance

    Time frame: 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).

    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.

Secondary outcomes

  1. Health-related quality of life

    Time frame: 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.

    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.

  2. Distance

    Time frame: 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).

    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.

Sponsors and collaborators

Lead sponsor

José Manuel Afonso Moreira

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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