Quality of LifePROM_RNCT06032013
Patient-Reported Outcome Measures in Cardiac Rehabilitation: Impact on Health Care
A study testing Cardiac rehabilitation program (PROMs) in people with Quality of Life and Cardiac Rehabilitation, run by José Manuel Afonso Moreira at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Cardiac Rehabilitation, Patient-Reported Outcome Measures
- What is being tested?
- Cardiac rehabilitation program (PROMs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2023to 1 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (> 18 years);
- Low-moderate risk for physical exercise;
- After a cardiac event;
- Have signed an informed consent form.
Who cannot join
- 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;
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- Uncontrolled diabetes;
- Acute pulmonary oedema in the last 12 hours;
- Those who refuse to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-Reported Outcome Measures and Quality of Life in Cardiac Rehabilitation: Impact on Health Care
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.
Read the detailed 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.
- Conditions
- Quality of Life, Cardiac Rehabilitation, Patient-Reported Outcome Measures, Rehabilitation Exercise
- Being tested
- Cardiac rehabilitation program (PROMs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitation program (PROMs)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation intervention | Experimental | Outpatient intervention with participants after a cardiac event who fulfil the inclusion criteria. Receives: Other: Cardiac rehabilitation program (PROMs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the intervention and up to 8 weeks.
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.
Measured: Before the intervention and up to 8 weeks.
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.
Measured: Before the intervention and up to 8 weeks.
Secondary outcomes (6)
Heart rate
Heart rate (bpm)
Measured: Before, during and up to 8 weeks of the program.
Blood pressure
Blood pressure (mmHg)
Measured: Before, during and up to 8 weeks of the program.
Peripheral oxygen saturation
Peripheral oxygen saturation (%)
Measured: Before, during and up to 8 weeks of the program.
Exercise Capacity
Borg scale- score 0-10. Higher values mean greater respiratory effort.
Measured: During and up to 8 weeks of the program.
Weight
Weight (Kg)
Measured: Before the intervention and up to 8 weeks.
Abdominal perimeter
Abdominal perimeter (cm)
Measured: Before the intervention and up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 May 2023
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Why it stopped: Completed with fewer participants than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- 5 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032013
- Sponsor's protocol ID
- National School Public Health
- Acronym
- PROM_R
- Status last verified
- Jul 2024
- First submitted
- 24 Aug 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Outcome Measures and Quality of Life in Cardiac Rehabilitation: Impact on Health Care
- ClinicalTrials.gov ID
- NCT06032013
- Acronym / sponsor ID
- PROM_R / National School Public Health
- Conditions
- Quality of Life, Cardiac Rehabilitation, Patient-Reported Outcome Measures, Rehabilitation Exercise
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Completed with fewer participants than expected
- Enrolment
- 5 participants (actual)
- Lead sponsor
- José Manuel Afonso MoreiraUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 11 Sep 2023 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation intervention | Experimental | Other: Cardiac rehabilitation program (PROMs)Outpatient intervention with participants after a cardiac event who fulfil the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (> 18 years);
- Low-moderate risk for physical exercise;
- After a cardiac event;
- Have signed an informed consent form.
Key exclusion criteria (9 listed)
- Physical or mental limitation to carry out an exercise programme;
- Uncontrolled arrhythmia;
- Severe chronic obstructive pulmonary disease;
- Uncontrolled hypertension;
- Symptomatic peripheral arterial disease;
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 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 | Other | Cardiac Rehabilitation intervention |
Primary outcome
EQ5D-5L: Health-related quality of life
Time frame: Before the intervention and up to 8 weeks.
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.
HADS: Anxiety and depression
Time frame: Before the intervention and up to 8 weeks.
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.
BREQ-2: Behavioural Regulations in Exercise Questionnaire
Time frame: Before the intervention and up to 8 weeks.
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.
6 secondary outcomes
Heart rate
Time frame: Before, during and up to 8 weeks of the program.
Blood pressure
Time frame: Before, during and up to 8 weeks of the program.
Peripheral oxygen saturation
Time frame: Before, during and up to 8 weeks of the program.
Exercise Capacity
Time frame: During and up to 8 weeks of the program.
Weight
Time frame: Before the intervention and up to 8 weeks.
Abdominal perimeter
Time frame: Before the intervention and up to 8 weeks.
Results and safety
The study was stopped early (reason given: Completed with fewer participants than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 program (PROMs) in people with Quality of Life and Cardiac Rehabilitation, 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 31 Jul 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 was stopped early (reason given: Completed with fewer participants than expected). Results are not available in the source record.
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?
EQ5D-5L: Health-related quality of life (time frame: Before the intervention and up to 8 weeks.). The study lists 3 primary outcomes in all. 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 31 Jul 2024.