NCT02219451

Brief Summary

The purpose of this study is to verify the effects of exercise training on sympathetic modulation and arterial baroreflex control in patients with chronic heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

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

August 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

8 months

First QC Date

August 4, 2014

Last Update Submit

August 18, 2014

Conditions

Keywords

Chronic heart failureexercise trainingSympathetic modulationarterial baroreflex control

Outcome Measures

Primary Outcomes (1)

  • Autonomic control

    To asses the effects of exercise training on sympathetic modulation by analyze of autonomic control in chronic heart failure patients after 4 months protocol.Time series of muscle sympathetic nerve activity and systolic arterial pressure were analyzed by autoregressive spectral analysis

    4 months

Secondary Outcomes (1)

  • Arterial baroreflex control

    4 months

Study Arms (1)

exercise training

EXPERIMENTAL

We studied twenty-six chronic heart failure outpatients and they were assigned to 2 groups: Untrained (n=13) and trained (n=13).

Other: exercise training

Interventions

exercise training

exercise training

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic heart failure
  • Age 30 to 70 years
  • Functional class II to III of New York Heart Association
  • Left ventricular ejection fraction (LVEF) ≤40%
  • Peak oxygen uptake (VO2) ≤20

You may not qualify if:

  • Recent myocardial infarction or unstable angina (\<3 months)
  • heart failure duration (\<3 months)
  • Permanent pacemaker dependence
  • Atrial fibrillation
  • Skeletal muscle abnormality (e.g., arthritis)
  • Participation in a regular exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração - HC/FMUSP

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (1)

  • Groehs RV, Toschi-Dias E, Antunes-Correa LM, Trevizan PF, Rondon MU, Oliveira P, Alves MJ, Almeida DR, Middlekauff HR, Negrao CE. Exercise training prevents the deterioration in the arterial baroreflex control of sympathetic nerve activity in chronic heart failure patients. Am J Physiol Heart Circ Physiol. 2015 May 1;308(9):H1096-102. doi: 10.1152/ajpheart.00723.2014. Epub 2015 Mar 6.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Heart Institute HC/FMUSP, HC/FMUSP

    Heart Institute, University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 19, 2014

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

August 19, 2014

Record last verified: 2014-08

Locations