NCT01884142

Brief Summary

The investigators hypothesize that exercise training would improve the mechanoreflex and metaboreflex control in heart failure patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable heart-failure

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, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

4.8 years

First QC Date

March 27, 2013

Last Update Submit

April 26, 2021

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Autonomic Control

    Mechanoreceptors were activated by passive exercise and metaboreceptors by post-exercise circulatory arrest

    4 months

  • Muscular Evaluation

    Muscular evaluation will be done by muscle gene expression

    4 months

Secondary Outcomes (3)

  • Functional Capacity

    4 months

  • Muscle Blood Flow

    4 months

  • Blood Pressure

    4 months

Study Arms (2)

Heart Failure Untrained Group

NO INTERVENTION

Control Group

Heart Failure Exercise-trained Group

EXPERIMENTAL

Aerobic Exercise Training

Other: Aerobic Exercise Training

Interventions

Aerobic Exercise TrainingOTHER
Heart Failure Exercise-trained Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with systolic heart failure;
  • New York Heart Association (NYHA) class II-III;
  • Left ventricular ejection fraction less than 40%;
  • Peak Oxygen Consumption less than 20 ml/Kg/min;
  • Stable Clinical Status.

You may not qualify if:

  • Chronic Obstructive Pulmonary Disease;
  • Neuromuscular Diseases;
  • Orthopedic Diseases;
  • Neurologic Diseases;
  • Neoplastic Diseases;
  • Recent myocardial infarction or cardiac surgery (less than 6 months);
  • Unstable angina pectoris;
  • Atrial Fibrillation;
  • Pacemakers users;
  • Changing medication or hospital admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute (InCor), University of Sao Paulo Medical School

São Paulo, 05403-904, Brazil

Location

Related Publications (1)

  • Unable to connect to PubMed to validate , last attempt on June 19, 2013 at 12:03 PM EDT

    BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Carlos E Negrão, PhD

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

March 27, 2013

First Posted

June 21, 2013

Study Start

March 1, 2008

Primary Completion

December 1, 2012

Study Completion

January 1, 2014

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

BR(1)