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| Name | Class |
|---|---|
| Clinica Las Americas | OTHER |
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Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in patients with chronic heart failure after participating in an exercise program and compare them baseline and 2 months, with another group who underwent an educational program.
Clinical controlled trial with a double blinded with a aleatory number sequence as the randomization method, patients will be assigned to one of two groups, intervention program (supervises exercise program) and control group (community based exercise)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| controlled, supervised exercise protocol | Active Comparator | controlled, supervised exercise protocol within a cardiac rehabilitation program |
|
| community based exercise | Placebo Comparator | educational program and not supervises exercise program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| controlled, supervised exercise protocol | Other | exercise program within a cardiac rehabilitation program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Natriuretic Brain Pro-peptid | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Consumption | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesus Alberto Plata Contreras, physiatrist | Rehabilitation in health research group. Universidad de Antioquia | Principal Investigator |
| Ana Milena García Montoya, Resident | Universidad de Antioquia,Rehabilitation in health research group | Study Chair |
| Sigifredo Ospina, Doctor | Hospital Universitario San Vicente Fundación | Principal Investigator |
| Luz Helena Lugo Agudelo, physiatrist | Universidad de Antioquia, Rehabilitation in health research group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Antioquia | Medellín | Antioquia | 050010 | Colombia |
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Outpatient with heart failure were recruited since March 2005 to January 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Controlled, Supervised Exercise Protocol | controlled, supervised exercise protocol within a cardiac rehabilitation program controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program |
| FG001 | Community Based Exercise |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| exercise protocol no supervised | Other | Exercise program at the community |
|
educational program and not supervises exercise program |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Controlled, Supervised Exercise Protocol | controlled, supervised exercise protocol within a cardiac rehabilitation program controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program |
| BG001 | Community Based Exercise | educational program and not supervises exercise program |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Natriuretic Brain pro-peptide | Median | Full Range | pg/ml |
| |||||||||||||||||
| Oxygen Consumption | Mean | Standard Deviation | ml/min |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Natriuretic Brain Pro-peptid | Posted | Median | Full Range | pg/ml | 8 weeks |
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| Secondary | Oxygen Consumption | Posted | Mean | Standard Deviation | ml/min | 8 weeks |
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from March 2005 to January 2008 (2 years and 10 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Controlled, Supervised Exercise Protocol | controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program | 0 | 20 | 0 | 20 | ||
| EG001 | Community Based Exercise | educational program and not supervises exercise program | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jesus Alberto Plata Contreras | Universidad de Antioquia | 5742196478 | rehabilitacionsalud@siu.udea.edu.co |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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| >=65 years |
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| Male |
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