Coronary Heart DiseasePhase 3NCT00146315
ESCAP: Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting
A Phase 3 study testing Supervised exercise on a stationary bicycle, 3-5 days a week and Secondary prevention program for coronary heart disease in people with Coronary Heart Disease, run by Basque Health Service at 2 sites in Spain.
Trial summary
In Spain, family physician are currently recommended to prescribe an unsupervised walking program to their coronary heart disease (CHD) patients as a part of their cardiac rehabilitation program. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Supervised exercise on a stationary bicycle, 3-5 days a week and Secondary prevention program for coronary heart disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2005to Jun 2010
- Phase
- Phase 3
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary heart disease low risk patients
- Under 80 years old
Who cannot join
- 80 years of age and over
- Patients included in cardiac rehabilitation programs
- Moderate and high risk patients
- Patients with handicaps for exercising
- Patients unable to attend the supervised exercise sessions
- Unstable angina
Show all 22Show fewer
- Uncontrolled atrial ventricular arrhythmias
- Third degree AV block (without pacemaker)
- Uncompensated congestive heart failure
- Severe aortic stenosis
- Suspected or known dissecting aneurysm
- Active myocarditis or pericarditis
- Thrombophlebitis
- Recent embolism
- Acute systemic illness or fever
- Significant emotional distress (psychosis)
- Orthostatic blood pressure drop of >20 mm Hg with symptoms
- Uncontrolled sinus tachycardia
- Resting ST segment displacement (>2 mm)
- Uncontrolled diabetes (resting blood glucose >400 mg/dl)
- Other metabolic problems such as acute thyroiditis, hypo or hyperkalemia, hypovolemia, etc.
- Resting SBP>200 mm Hg or resting DBP>110 mm Hg
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Primary Care Research Unit of Bizkaia (Basque Health Service)
Bilbao, Bizkaia, 48014
Santa Barbara primary care center (Castilla La Mancha Health Service)
Toledo, Toledo, 45007
About this study
Official title: Effectiveness of the Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting (ESCAP): a Randomized Clinical Trial
In Spain, family physician are currently recommended to prescribe an unsupervised walking program to their coronary heart disease (CHD) patients as a part of their cardiac rehabilitation program. However, there are a few family physicians who provide their CHD patients with supervised exercise (30 minutes of pedaling on an stationary bicycle at 60-85% of the peak heart rate (HR) attained at the maximal or symptom limited treadmill test, 3 times a week) at their primary care health centers, thinking that these patients improve their functional capacity, quality of life, and the control of cardiovascular risk factors, more than walking because they can not achieve the ideal exercise intensity for maximal benefits by walking. This study has been designed to investigate if CHD patients get more health benefits with the supervised exercise program at the health center than with the unsupervised walking program.
Read the detailed description
In order to obtain the maximal health benefits, CHD patients have to attain an exercise intensity between 60 and 85% of the maximal or symptom-limited heart rate (HR). This is not currently attained by the patients who are prescribed an unsupervised walking program.
The OBJECTIVE of this randomized clinical trial is to investigate if CHD patients improve their functional capacity and quality of life more, and control their cardiovascular risk factors better, by coming to their health centers to pedal during 30 minutes on an stationary bicycle , 3 or more times a week, with a HR monitor which makes sure that they attain HRs within the prescribed interval, and supervised by health personal, than by walking without supervision. For that purpose, low risk CHD patients from 11 Spanish health centers will be randomly assigned to a supervised exercise group (ESCAP) or to another unsupervised walking group (control). Both groups will be also provided with health education and the corresponding treatment for cardiovascular risk factor control and complication prevention by their family physicians. The average changes observed in the two groups will be compared, on the basis of intention to treat through analysis of covariance. We will use mixed-effect models to take into account intra-patients and intra-center correlation.
- Conditions
- Coronary Heart Disease
- Being tested
- Supervised exercise on a stationary bicycle, 3-5 days a week, Secondary prevention program for coronary heart disease
- Keywords
- Primary Health Care, Family Practice, Family Physician, Exercise, Coronary Heart Disease, Randomized Controlled Trials, Multicenter Studies
- Medical subject headings
- Coronary Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise on a stationary bicycle, 3-5 days a weekBehavioural
Supervised exercise on a stationary bicycle, 3-5 days a week, plus a secondary prevention program for coronary heart disease
Secondary prevention program for coronary heart diseaseBehavioural
Secondary prevention program for coronary heart disease
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Secondary prevention program for coronary heart disease Receives: Behavioral: Secondary prevention program for coronary heart disease |
| Supervised exercise | Experimental | Not described Receives: Behavioral: Supervised exercise on a stationary bicycle, 3-5 days a week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity (exercise treadmill test)
Measured: 6 months follow-up
Secondary outcomes (2)
Health Related Quality of life (SF-36)
Measured: 6 months follow-up
Cardiovascular risk factor control
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Collaborators
- Preventive Services and Health Promotion Research Network, Castilla-La Mancha Health Service, Castilla-León Health Service, Dalt Sant Joan primary care center (Balears Islans Health Service), Public Health Service of Cataluña, Public Health Service of Madrid, Public Health Service of Galicia, Cantabria Health Service
- Investigators
- Ricardo Ortega, Dr., Principal investigator, Santa Barbara primary care center (Castilla La Mancha Health Service)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146315
- Sponsor's protocol ID
- ESCAP-G03/170-200311075
- Status last verified
- May 2011
- First submitted
- 6 Sep 2005
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ortega Sanchez-Pinilla R. [Differences in intensity of effort between supervised and non-supervised exercise of patients with ischaemic cardiopathy]. Aten Primaria. 2004 Sep 30;34(5):265-6. doi: 10.1016/s0212-6567(04)70847-1. No abstract available. Spanish.
PubMed 15456577Ortega R, Garcia-Ortiz L, Torcal J, Echevarria P, Vargas-Machuca C, Gomez A, Salcedo F, Lekuona I, Montoya I, Grandes G; ESCAP Group. Supervised exercise for acute coronary patients in primary care: a randomized clinical trial. Fam Pract. 2014 Feb;31(1):20-9. doi: 10.1093/fampra/cmt059. Epub 2013 Oct 19.
PubMed 24142481
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting (ESCAP): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00146315
- Acronym / sponsor ID
- ESCAP-G03/170-200311075
- Conditions
- Coronary Heart Disease
- Keywords
- Primary Health Care, Family Practice, Family Physician, Exercise, Coronary Heart Disease, Randomized Controlled Trials, Multicenter Studies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Collaborators
- Preventive Services and Health Promotion Research Network, Castilla-La Mancha Health Service, Castilla-León Health Service, Dalt Sant Joan primary care center (Balears Islans Health Service), Public Health Service of Cataluña, Public Health Service of Madrid, Public Health Service of Galicia, Cantabria Health Service
- Study start
- Jan 2005
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Sep 2005 (estimated)
- 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.
In Spain, family physician are currently recommended to prescribe an unsupervised walking program to their coronary heart disease (CHD) patients as a part of their cardiac rehabilitation program. However, there are a few family physicians who provide their CHD patients with supervised exercise (30 minutes of pedaling on an stationary bicycle at 60-85% of the peak heart rate (HR) attained at the maximal or symptom limited treadmill test, 3 times a week) at their primary care health centers, thinking that these patients improve their functional capacity, quality of life, and the control of cardiovascular risk factors, more than walking because they can not achieve the ideal exercise intensity for maximal benefits by walking. This study has been designed to investigate if CHD patients get more health benefits with the supervised exercise program at the health center than with the unsupervised walking program.
Detailed description
In order to obtain the maximal health benefits, CHD patients have to attain an exercise intensity between 60 and 85% of the maximal or symptom-limited heart rate (HR). This is not currently attained by the patients who are prescribed an unsupervised walking program.
The OBJECTIVE of this randomized clinical trial is to investigate if CHD patients improve their functional capacity and quality of life more, and control their cardiovascular risk factors better, by coming to their health centers to pedal during 30 minutes on an stationary bicycle , 3 or more times a week, with a HR monitor which makes sure that they attain HRs within the prescribed interval, and supervised by health personal, than by walking without supervision. For that purpose, low risk CHD patients from 11 Spanish health centers will be randomly assigned to a supervised exercise group (ESCAP) or to another unsupervised walking group (control). Both groups will be also provided with health education and the corresponding treatment for cardiovascular risk factor control and complication prevention by their family physicians. The average changes observed in the two groups will be compared, on the basis of intention to treat through analysis of covariance. We will use mixed-effect models to take into account intra-patients and intra-center correlation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Secondary prevention program for coronary heart diseaseSecondary prevention program for coronary heart disease |
| Supervised exercise | Experimental | Behavioral: Supervised exercise on a stationary bicycle, 3-5 days a week |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary heart disease low risk patients
- Under 80 years old
Key exclusion criteria (22 listed)
- 80 years of age and over
- Patients included in cardiac rehabilitation programs
- Moderate and high risk patients
- Patients with handicaps for exercising
- Patients unable to attend the supervised exercise sessions
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 |
|---|---|---|
| Supervised exercise on a stationary bicycle, 3-5 days a weekSupervised exercise on a stationary bicycle, 3-5 days a week, plus a secondary prevention program for coronary heart disease | Behavioural | Supervised exercise |
| Secondary prevention program for coronary heart diseaseSecondary prevention program for coronary heart disease | Behavioural | Control |
Primary outcome
Functional capacity (exercise treadmill test)
Time frame: 6 months follow-up
2 secondary outcomes
Health Related Quality of life (SF-36)
Time frame: 6 months follow-up
Cardiovascular risk factor control
Time frame: 6 months follow-up
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 1 Jun 2011.
- Background: PubMed 15456577Ortega Sanchez-Pinilla R. [Differences in intensity of effort between supervised and non-supervised exercise of patients with ischaemic cardiopathy]. Aten Primaria. 2004 Sep 30;34(5):265-6. doi: 10.1016/s0212-6567(04)70847-1. No abstract available. Spanish.
- Derived from this study: PubMed 24142481Ortega R, Garcia-Ortiz L, Torcal J, Echevarria P, Vargas-Machuca C, Gomez A, Salcedo F, Lekuona I, Montoya I, Grandes G; ESCAP Group. Supervised exercise for acute coronary patients in primary care: a randomized clinical trial. Fam Pract. 2014 Feb;31(1):20-9. doi: 10.1093/fampra/cmt059. Epub 2013 Oct 19.
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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.
Ricardo Ortega, Dr. principal investigator
Santa Barbara primary care center (Castilla La Mancha Health Service)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supervised exercise on a stationary bicycle, 3-5 days a week and Secondary prevention program for coronary heart disease in people with Coronary Heart Disease, run by Basque Health Service 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 2 inclusion and 22 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 1 Jun 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional capacity (exercise treadmill test) (time frame: 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00146315, which also lists 2 linked publications.
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 1 Jun 2011.