Quality of LifeNCT03643536
12-week Exercise-based Program in Myocardial Revascularization Subjects
A study testing 12-WPEP in people with Quality of Life, run by Fundación del Caribe para la Investigación Biomédica at 1 site in Colombia.
Trial summary
To determine if a 12-week physical exercise program (12-WPEP), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) with different left ventricular ejection fraction (LVEF) might improve the health-related quality of life (HRQOL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- 12-WPEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2014to 31 Mar 2015
- 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
- CABG or post-PCI subjects and agreed to participate by signing the informed consent form.
Who cannot join
- Subjects with musculoskeletal limitations for physical exercise, untreated ventricular arrhythmias, with the presence of residual pericardial effusion, history of intermittent claudication or left ventricular ejection fraction <30% measured by 2D-echocardiography
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundacion del Caribe para la Investigacion Biomedica (Fundacion Bios)
Barranquilla, Atlántico, 080020
About this study
Official title: Effects of a 12-week Exercise-based Program on Quality of Life in Myocardial Revascularization Subjects With Normal and Reduced Left Ventricular Ejection Fraction
To determine if a 12-week physical exercise program (12-WPEP), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) with different left ventricular ejection fraction (LVEF) might improve the health-related quality of life (HRQOL).
Read the detailed description
Percutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG) are interventions that can reduce cardiovascular symptoms such as dyspnea and angina. The life quality and the functional capacity improved in the subjects who underwent surgery. However, new cardiac events, death and obstruction of the bypass placed can exist. To diminish these risks, national and international guides recommend cardiac rehabilitation (CR) for people with coronary disease, who have suffered a myocardial infarction and are subjected to CABG and PCI. A 20-30% reduction of morbidity and mortality can be obtained with the use of CR. According to the European Society of Cardiology (ESC), the American Heart Association (AHA) and the American College of Cardiology (ACC), CR is a recommendation Class Type I, in subjects treated with PCI and CABG. This includes prescribed physical exercises, education, and counseling to modify the effects of coronary heart disease and improve long-term survival. Exercise-based cardiac rehabilitation is an effective and safe therapy to be used in the management of clinically stable patients following PCI or CABG. The maximum oxygen uptake (VO2max) is improved by the exercise carried out during CR, optimizing the physical condition and health-related quality of life (HRQOL).
The HRQOL is considered a very important criterion used to evaluate the effectiveness of different treatments in patients with coronary disease, and is defined by subjective evaluation regarding the current activities of health care and health promotion; it indicates the personal perception in various aspects such as the recovery of the functional, labor, sexual and social capabilities of the patient, factors that have great importance in the evolution of the patient; this perception is considered the best indicator of quality of life, and has become a key concept for the decision making. In this study, we will evaluate the effects of a physical exercise program in the health-related quality of life of subjects following CABG or PCI with normal and reduced left ventricular ejection fraction (LVEF)
- Conditions
- Quality of Life
- Being tested
- 12-WPEP
- Keywords
- left ventricular ejection fraction; quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-WPEPOther
The 12-WPEP (week physical exercise program) was carried out in 3 sessions each 40 or 60minutes with alternate days per week during 3 months, and with an intensity between 40 to 80 percent of their VO2 max, as the AHA recommends
| Study group | Role | What they receive |
|---|---|---|
| 12-WPEP in subjects with reduce LVEF | Experimental | Intervention: a 12 week physical exercise program in the health-related quality of life of CABG or PCI subjects with LVEF by 2D-echocardiography between 30-54%. The quality of life was measured using SF-36 questionnaire Receives: Other: 12-WPEP |
| 12-WPEP in subjects with normal LVEF | Active comparator | Intervention: a 12 week physical exercise program in the health-related quality of life of or PCI subjects with LVEF by 2D-echocardiography≥ 55% (control group)The quality of life was measured using SF-36 questionnaire Receives: Other: 12-WPEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQOL)
For the evaluation of health-related quality of life, 36 health survey questionnaire (SF-36) was used. This questionnaire has 36 questions that address two major components based on 8 fields: physical component which includes physical functioning, physical performance, pain and general health, and the mental component which includes vitality, social function, emotional role and mental health.To calculate the score, the items for each one of the eight dimensions are encoded, added and transformed into a scale from 0 (worst health status for this dimension) to 100 (best health status).
Measured: 12 weeks after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Jan 2014
- Primary completion31 Dec 2014
- Study completion31 Mar 2015
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
- Non-randomised
- Intervention model
- Single group
- Model description
- A prospective controlled before-after study
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación del Caribe para la Investigación Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel Urina-Triana, PhD ( c), Study director, Fundacion del Caribe para la Investigacion BiomedicaMirary Mantilla-Morron, Principal investigator, Fundacion del Caribe para la Investigacion Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643536
- Sponsor's protocol ID
- 2018200801
- Status last verified
- Jan 2014
- First submitted
- 21 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-week Exercise-based Program on Quality of Life in Myocardial Revascularization Subjects With Normal and Reduced Left Ventricular Ejection Fraction
- ClinicalTrials.gov ID
- NCT03643536
- Acronym / sponsor ID
- 2018200801
- Conditions
- Quality of Life
- Keywords
- left ventricular ejection fraction; quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Fundación del Caribe para la Investigación BiomédicaUniversity, hospital or other
- Study start
- 1 Jan 2014
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 22 Aug 2018 (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.
To determine if a 12-week physical exercise program (12-WPEP), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) with different left ventricular ejection fraction (LVEF) might improve the health-related quality of life (HRQOL).
Detailed description
Percutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG) are interventions that can reduce cardiovascular symptoms such as dyspnea and angina. The life quality and the functional capacity improved in the subjects who underwent surgery. However, new cardiac events, death and obstruction of the bypass placed can exist. To diminish these risks, national and international guides recommend cardiac rehabilitation (CR) for people with coronary disease, who have suffered a myocardial infarction and are subjected to CABG and PCI. A 20-30% reduction of morbidity and mortality can be obtained with the use of CR. According to the European Society of Cardiology (ESC), the American Heart Association (AHA) and the American College of Cardiology (ACC), CR is a recommendation Class Type I, in subjects treated with PCI and CABG. This includes prescribed physical exercises, education, and counseling to modify the effects of coronary heart disease and improve long-term survival. Exercise-based cardiac rehabilitation is an effective and safe therapy to be used in the management of clinically stable patients following PCI or CABG. The maximum oxygen uptake (VO2max) is improved by the exercise carried out during CR, optimizing the physical condition and health-related quality of life (HRQOL).
The HRQOL is considered a very important criterion used to evaluate the effectiveness of different treatments in patients with coronary disease, and is defined by subjective evaluation regarding the current activities of health care and health promotion; it indicates the personal perception in various aspects such as the recovery of the functional, labor, sexual and social capabilities of the patient, factors that have great importance in the evolution of the patient; this perception is considered the best indicator of quality of life, and has become a key concept for the decision making. In this study, we will evaluate the effects of a physical exercise program in the health-related quality of life of subjects following CABG or PCI with normal and reduced left ventricular ejection fraction (LVEF)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective controlled before-after study
| Arm | Type | Receives |
|---|---|---|
| 12-WPEP in subjects with reduce LVEF | Experimental | Other: 12-WPEPIntervention: a 12 week physical exercise program in the health-related quality of life of CABG or PCI subjects with LVEF by 2D-echocardiography between 30-54%. The quality of life was measured using SF-36 questionnaire |
| 12-WPEP in subjects with normal LVEF | Active comparator | Other: 12-WPEPIntervention: a 12 week physical exercise program in the health-related quality of life of or PCI subjects with LVEF by 2D-echocardiography≥ 55% (control group)The quality of life was measured using SF-36 questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CABG or post-PCI subjects and agreed to participate by signing the informed consent form.
Key exclusion criteria (1 listed)
- Subjects with musculoskeletal limitations for physical exercise, untreated ventricular arrhythmias, with the presence of residual pericardial effusion, history of intermittent claudication or left ventricular ejection fraction <30% measured by 2D-echocardiography
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 |
|---|---|---|
| 12-WPEPThe 12-WPEP (week physical exercise program) was carried out in 3 sessions each 40 or 60minutes with alternate days per week during 3 months, and with an intensity between 40 to 80 percent of their VO2 max, as the AHA recommends | Other | 12-WPEP in subjects with normal LVEF, 12-WPEP in subjects with reduce LVEF |
Primary outcome
Health-related quality of life (HRQOL)
Time frame: 12 weeks after the inclusion
For the evaluation of health-related quality of life, 36 health survey questionnaire (SF-36) was used. This questionnaire has 36 questions that address two major components based on 8 fields: physical component which includes physical functioning, physical performance, pain and general health, and the mental component which includes vitality, social function, emotional role and mental health.To calculate the score, the items for each one of the eight dimensions are encoded, added and transformed into a scale from 0 (worst health status for this dimension) to 100 (best health status).
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 22 Aug 2018.
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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.
Miguel Urina-Triana, PhD ( c) study director
Fundacion del Caribe para la Investigacion Biomedica
Mirary Mantilla-Morron principal investigator
Fundacion del Caribe para la Investigacion Biomedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-WPEP in people with Quality of Life, run by Fundación del Caribe para la Investigación Biomédica at 1 site in Colombia.
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 1 inclusion and 1 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 22 Aug 2018. 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 Colombia. 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?
Health-related quality of life (HRQOL) (time frame: 12 weeks after the inclusion). 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 22 Aug 2018.