Coronary Artery DiseasePRECICANCT07704086
Prehabilitation for Patients Undergoing Elective Cardiac Surgery
A study testing Physical exercise and Educational program and respiration physiotherapy in people with Coronary Artery Disease and Valvular Heart Disease, run by Hospital Universitario 12 de Octubre at 2 sites in Spain.
Trial summary
The objective of this clinical trial is to develop a novel rehabilitation model that, through the PRECICA program, will help to reduce perioperative and postoperative complications in the care process prior to planned cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Valvular Heart Disease, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Physical exercise and Educational program and respiration physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2024to 10 Jul 2026
- 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
- Adults aged 18 years or older.
- Scheduled for elective cardiac surgery for one or more of the following indications:
- Coronary artery disease.
- Valvular heart disease.
- Chronic thromboembolic pulmonary hypertension.
- Aortic disease.
Who cannot join
- Cognitive impairment that prevents understanding the study procedures or completing the intervention.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Universidad Complutense de Madrid
Madrid, Madrid
About this study
Official title: Effects of a Prehabilitation Program in Elective Cardiac Surgery on Functional Status and Quality of Life in the Short and Medium Term. Randomized Clinical Trial: PRECICA Study
The objective of this clinical trial is to develop a novel rehabilitation model that, through the PRECICA program, will help to reduce perioperative and postoperative complications in the care process prior to planned cardiac surgery. This will be achieved by reducing the total postoperative hospital stay and the physical and psychological complications resulting from surgery. The target population for this trial is patients undergoing planned cardiac surgery due to chronic coronary artery disease, valvular pathology, chronic thromboembolic pulmonary hypertension and/or aortic injury. Consequently, the quality of life of these patients could be enhanced.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Chronic Thromboembolic Pulmonary Hypertension, Aortic Diseases
- Being tested
- Physical exercise, Educational program and respiration physiotherapy
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
A program designed to enhance muscular strength through a structured exercise program.
Educational program and respiration physiotherapyOther
The program will include a health education component and respiratory physiotherapy techniques.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Not described Receives: Other: Physical exercise; Other: Educational program and respiration physiotherapy |
| Standard care | Other | The standard of care is defined as a health education program and education in respiratory physiotherapy techniques. Receives: Other: Educational program and respiration physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk test
A functional capacity test (six-minute walk test) will be conducted to assess the subject's cardiovascular capacity.
Measured: This variable will be measured at four different time points; in the inclusion of the patient in the study, on the day of admission prior to surgery, one week after hospital discharge, and 2 months after surgery.
Quality of life (EQ-5D-5L)
The standard of health experienced
Measured: This variable will be measured at four different time points; in the inclusion of the patient in the study, on the day of admission prior to surgery, one week after hospital discharge, and 2 months after surgery.
Secondary outcomes (1)
Period of hospitalization
The number of days spent in the hospital under surgical observation.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jun 2024
- Primary completion1 Jun 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prehabilitation in Cardiac Surgery, which will consist of a health education program, respiratory physiotherapy techniques, a health education program, and a peripheral muscle strength program.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Izquierdo García, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704086
- Sponsor's protocol ID
- PRECICA
- Acronym
- PRECICA
- Status last verified
- Jul 2026
- First submitted
- 8 May 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Prehabilitation Program in Elective Cardiac Surgery on Functional Status and Quality of Life in the Short and Medium Term. Randomized Clinical Trial: PRECICA Study
- ClinicalTrials.gov ID
- NCT07704086
- Acronym / sponsor ID
- PRECICA / PRECICA
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Chronic Thromboembolic Pulmonary Hypertension, Aortic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 15 Jul 2026 (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 objective of this clinical trial is to develop a novel rehabilitation model that, through the PRECICA program, will help to reduce perioperative and postoperative complications in the care process prior to planned cardiac surgery. This will be achieved by reducing the total postoperative hospital stay and the physical and psychological complications resulting from surgery. The target population for this trial is patients undergoing planned cardiac surgery due to chronic coronary artery disease, valvular pathology, chronic thromboembolic pulmonary hypertension and/or aortic injury. Consequently, the quality of life of these patients could be enhanced.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prehabilitation in Cardiac Surgery, which will consist of a health education program, respiratory physiotherapy techniques, a health education program, and a peripheral muscle strength program.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: Physical exercise, Other: Educational program and respiration physiotherapy |
| Standard care | Other | Other: Educational program and respiration physiotherapyThe standard of care is defined as a health education program and education in respiratory physiotherapy techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Scheduled for elective cardiac surgery for one or more of the following indications:
- Coronary artery disease.
- Valvular heart disease.
- Chronic thromboembolic pulmonary hypertension.
Key exclusion criteria (1 listed)
- Cognitive impairment that prevents understanding the study procedures or completing the intervention.
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 |
|---|---|---|
| Physical exerciseA program designed to enhance muscular strength through a structured exercise program. | Other | Prehabilitation |
| Educational program and respiration physiotherapyThe program will include a health education component and respiratory physiotherapy techniques. | Other | Prehabilitation, Standard care |
Primary outcome
Six minute walk test
Time frame: This variable will be measured at four different time points; in the inclusion of the patient in the study, on the day of admission prior to surgery, one week after hospital discharge, and 2 months after surgery.
A functional capacity test (six-minute walk test) will be conducted to assess the subject's cardiovascular capacity.
Quality of life (EQ-5D-5L)
Time frame: This variable will be measured at four different time points; in the inclusion of the patient in the study, on the day of admission prior to surgery, one week after hospital discharge, and 2 months after surgery.
The standard of health experienced
1 secondary outcome
Period of hospitalization
Time frame: Through study completion, an average of 1 year
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 15 Jul 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and Educational program and respiration physiotherapy in people with Coronary Artery Disease and Valvular Heart Disease, run by Hospital Universitario 12 de Octubre at 2 sites in Spain.
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 6 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Six minute walk test (time frame: This variable will be measured at four different time points; in the inclusion of the patient in the study, on the day of admission prior to surgery, one week after hospital discharge, and 2 months after surgery.). The study lists 2 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 15 Jul 2026.