NCT02087670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 7, 2014

Completed
Last Updated

March 10, 2016

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

March 12, 2014

Results QC Date

April 22, 2014

Last Update Submit

February 9, 2016

Conditions

Chronic Heart Failure

Keywords

chronic heart failurecardiac rehabilitationexerciseNatriuretic Brain Pro-peptid

Outcome Measures

Primary Outcomes (1)

  • Natriuretic Brain Pro-peptid

    8 weeks

Secondary Outcomes (1)

  • Oxygen Consumption

    8 weeks

Study Arms (2)

controlled, supervised exercise protocol

ACTIVE COMPARATOR

controlled, supervised exercise protocol within a cardiac rehabilitation program

Other: controlled, supervised exercise protocol

community based exercise

PLACEBO COMPARATOR

educational program and not supervises exercise program

Other: exercise protocol no supervised

Interventions

controlled, supervised exercise protocolOTHER

exercise program within a cardiac rehabilitation program

controlled, supervised exercise protocol
exercise protocol no supervisedOTHER

Exercise program at the community

community based exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years, diagnosed with heart failure (NYHA) II-IV for more than six months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Antioquia

Medellín, Antioquia, 050010, Colombia

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Results Point of Contact

Title
Jesus Alberto Plata Contreras
Organization
Universidad de Antioquia
rehabilitacionsalud@siu.udea.edu.co
5742196478

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D Epidemiologist

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 14, 2014

Study Start

March 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

March 10, 2016

Results First Posted

August 7, 2014

Record last verified: 2016-02

Locations

CO(1)