Myocardial IschemiaNCT06546878
Cardiac Rehabilitation: Optimisation of the Functional Capacity of Patients Hospitalized With Cardiac Disease
A study testing Cardiac Rehabilitation (Phase I) - nurse intervention in people with Myocardial Ischemia and Heart Diseases, run by José Manuel Afonso Moreira at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Ischemia, Heart Diseases
- What is being tested?
- Cardiac Rehabilitation (Phase I) - nurse intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who do not meet the safety criteria for exercising after a cardiac event
- Patients with osteoarticular pathology that compromises their ability to exercise.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Cardiac Rehabilitation (Phase I) - nurse intervention
- Keywords
- Cardiac Rehabilitation, Phase I, Myocardial Ischemia, Rehabilitation Nursing
- Medical subject headings
- Myocardial Ischemia, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation (Phase I) - nurse interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Procedure: Cardiac Rehabilitation (Phase I) - nurse intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 May 2024
- Primary completion12 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- José Manuel Afonso Moreira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José Manuel Afonso Moreira, University of Évora
- Investigators
- José Moreira, MsC, Study chair, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546878
- Sponsor's protocol ID
- Polytechnic Institute of Beja
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation: Optimisation of the Functional Capacity of Patients Hospitalized With Cardiac Disease
- ClinicalTrials.gov ID
- NCT06546878
- Acronym / sponsor ID
- Polytechnic Institute of Beja
- Conditions
- Myocardial Ischemia, Heart Diseases
- Keywords
- Cardiac Rehabilitation, Phase I, Myocardial Ischemia, Rehabilitation Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- José Manuel Afonso MoreiraUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Cardiac Rehabilitation (Phase I) - nurse intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who do not meet the safety criteria for exercising after a cardiac event
- Patients with osteoarticular pathology that compromises their ability to exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Rehabilitation (Phase I) - nurse interventionThe 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. | Procedure or surgery | Intervention Group |
Primary outcome
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.
2 secondary outcomes
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Moreira, MsC study chair
University of Évora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation (Phase I) - nurse intervention in people with Myocardial Ischemia and Heart Diseases, run by José Manuel Afonso Moreira at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.