NCT01747395

Brief Summary

The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits compared to isolated exercise training or respiratory training in chronic heart failure patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

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, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

7.7 years

First QC Date

December 6, 2012

Last Update Submit

April 27, 2021

Conditions

Heart Failure

Keywords

Heart FailureExercise and Physical Fitness

Outcome Measures

Primary Outcomes (1)

  • Autonomic control

    Exercise training associated with inspiratory muscle training will reduce sympathetic nerve activity.

    4 months

Secondary Outcomes (5)

  • Functional Capacity

    4 months

  • Quality of life

    4 months

  • Blood inflammatory markers

    4 months

  • Muscular evaluation

    4 months

  • Respiratoy muscle function

    4 months

Study Arms (4)

Control Group

NO INTERVENTION

No exercise group (sedentary)

Aerobic Exercise Training

EXPERIMENTAL

Group undergoing isolate aerobic exercise training 3 times/week, during 40 minutes, for 04 mouths

Other: Exercise training

Inspiratory Muscle Training

EXPERIMENTAL

Group undergoing isolate inspiratory muscle training 7 times/week, during 30 minutes, for 04 mouths

Other: Exercise training

Aerobic+Inspiratory Muscle Training

EXPERIMENTAL

Group undergoing aerobic exercise training (3 times/week during 40 minutes) associate inspiratory muscle training (7 times/week during 30 minutes) for 04 mounths

Other: Exercise training

Interventions

Exercise trainingOTHER

The heart failure patients are subjected to differents protocols of physical training

Aerobic Exercise TrainingAerobic+Inspiratory Muscle TrainingInspiratory Muscle Training

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração - HC/FMUSP

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Antunes-Correa LM, Trevizan PF, Bacurau AVN, Ferreira-Santos L, Gomes JLP, Urias U, Oliveira PA, Alves MJNN, de Almeida DR, Brum PC, Oliveira EM, Hajjar L, Kalil Filho R, Negrao CE. Effects of aerobic and inspiratory training on skeletal muscle microRNA-1 and downstream-associated pathways in patients with heart failure. J Cachexia Sarcopenia Muscle. 2020 Feb;11(1):89-102. doi: 10.1002/jcsm.12495. Epub 2019 Nov 19.

    PMID: 31743617DERIVED

MeSH Terms

Conditions

Heart FailureMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Carlos Eduardo Negrão

    InCor, HCFMUSP

    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

Study Record Dates

First Submitted

December 6, 2012

First Posted

December 11, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2020

Study Completion

July 1, 2021

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations

BR(1)