Back to resultsNatriuretic Brain Pro-peptid Changes in Patients With Chronic Heart Failure Within a Cardiac Rehabilitation Program
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
controlled, supervised exercise protocol
exercise protocol no supervised
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring chronic heart failure, cardiac rehabilitation, exercise, Natriuretic Brain Pro-peptid
Eligibility Criteria
Inclusion Criteria:
- Patients older than 18 years, diagnosed with heart failure (NYHA) II-IV for more than six months
Exclusion Criteria:
- patients with NYHA functional class I, who had attended a cardiac rehabilitation program previously, patients with decompensated diabetes mellitus, hypertension difficult to control, ischemic heart disease in the last month, prior pulmonary embolism, chronic obstructive pulmonary disease, restrictive lung disease , aortic stenosis, new episode of atrial fibrillation and musculoskeletal diseases that limit the performance of physical activity
Sites / Locations
- Universidad de Antioquia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
controlled, supervised exercise protocol
community based exercise
Arm Description
controlled, supervised exercise protocol within a cardiac rehabilitation program
educational program and not supervises exercise program
Outcomes
Primary Outcome Measures
Natriuretic Brain Pro-peptid
Secondary Outcome Measures
Oxygen Consumption
Full Information
NCT ID
NCT02087670
First Posted
March 12, 2014
Last Updated
February 9, 2016
Sponsor
Grupo Rehabilitacion en Salud
Collaborators
Clinica Las Americas
1. Study Identification
Unique Protocol Identification Number
NCT02087670
Brief Title
Natriuretic Brain Pro-peptid Changes in Patients With Chronic Heart Failure Within a Cardiac Rehabilitation Program
Official Title
Natriuretic Brain Pro-peptid (Pro-BNP)Changes in Patients With Chronic Heart Failure Enroled in a Controlled, Supervised Exercise Protocol Within a Cardiac Rehabilitation Program
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grupo Rehabilitacion en Salud
Collaborators
Clinica Las Americas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, cardiac rehabilitation, exercise, Natriuretic Brain Pro-peptid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
controlled, supervised exercise protocol
Arm Type
Active Comparator
Arm Description
controlled, supervised exercise protocol within a cardiac rehabilitation program
Arm Title
community based exercise
Arm Type
Placebo Comparator
Arm Description
educational program and not supervises exercise program
Intervention Type
Other
Intervention Name(s)
controlled, supervised exercise protocol
Intervention Description
exercise program within a cardiac rehabilitation program
Intervention Type
Other
Intervention Name(s)
exercise protocol no supervised
Intervention Description
Exercise program at the community
Primary Outcome Measure Information:
Title
Natriuretic Brain Pro-peptid
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Oxygen Consumption
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 18 years, diagnosed with heart failure (NYHA) II-IV for more than six months
Exclusion Criteria:
patients with NYHA functional class I, who had attended a cardiac rehabilitation program previously, patients with decompensated diabetes mellitus, hypertension difficult to control, ischemic heart disease in the last month, prior pulmonary embolism, chronic obstructive pulmonary disease, restrictive lung disease , aortic stenosis, new episode of atrial fibrillation and musculoskeletal diseases that limit the performance of physical activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Alberto Plata Contreras, physiatrist
Organizational Affiliation
Rehabilitation in health research group. Universidad de Antioquia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana Milena García Montoya, Resident
Organizational Affiliation
Universidad de Antioquia,Rehabilitation in health research group
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sigifredo Ospina, Doctor
Organizational Affiliation
Hospital Universitario San Vicente Fundación
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luz Helena Lugo Agudelo, physiatrist
Organizational Affiliation
Universidad de Antioquia, Rehabilitation in health research group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Antioquia
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050010
Country
Colombia
12. IPD Sharing Statement
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Natriuretic Brain Pro-peptid Changes in Patients With Chronic Heart Failure Within a Cardiac Rehabilitation Program
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