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Exercise Training Associated With Inspiratory Muscle Training in Heart Failure

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Exercise and Physical Fitness

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Instituto do Coração - HC/FMUSP

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control Group

Aerobic Exercise Training

Inspiratory Muscle Training

Aerobic+Inspiratory Muscle Training

Arm Description

No exercise group (sedentary)

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional Capacity
Exercise training associated with inspiratory muscle training will improve peak oxygen consumption
Quality of life
Exercise training associated with inspiratory muscle training will improve quality of life
Blood inflammatory markers
Exercise training associated with inspiratory muscle training will reduces blood inflammatory markers
Muscular evaluation
Exercise training associated with inspiratory muscle training will increase skeletal muscle strength
Respiratoy muscle function
Exercise training associated with inspiratory muscle training will increase inspitarory muscle strength and endurance.

Full Information

First Posted
December 6, 2012
Last Updated
April 27, 2021
Sponsor
University of Sao Paulo General Hospital
Collaborators
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01747395
Brief Title
Exercise Training Associated With Inspiratory Muscle Training in Heart Failure
Official Title
Effects of Aerobic Exercise Training Associated With Inspiratory Muscle Training in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The investigators hypothesize that aerobic exercise training associated with respiratory muscle training will cause additional benefits in the autonomic control and respiratory function compared to isolated exercise training or respiratory training in chronic heart failure patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Exercise and Physical Fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No exercise group (sedentary)
Arm Title
Aerobic Exercise Training
Arm Type
Experimental
Arm Description
Group undergoing isolate aerobic exercise training 3 times/week, during 40 minutes, for 04 mouths
Arm Title
Inspiratory Muscle Training
Arm Type
Experimental
Arm Description
Group undergoing isolate inspiratory muscle training 7 times/week, during 30 minutes, for 04 mouths
Arm Title
Aerobic+Inspiratory Muscle Training
Arm Type
Experimental
Arm Description
Group undergoing aerobic exercise training (3 times/week during 40 minutes) associate inspiratory muscle training (7 times/week during 30 minutes) for 04 mounths
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
The heart failure patients are subjected to differents protocols of physical training
Primary Outcome Measure Information:
Title
Autonomic control
Description
Exercise training associated with inspiratory muscle training will reduce sympathetic nerve activity.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Functional Capacity
Description
Exercise training associated with inspiratory muscle training will improve peak oxygen consumption
Time Frame
4 months
Title
Quality of life
Description
Exercise training associated with inspiratory muscle training will improve quality of life
Time Frame
4 months
Title
Blood inflammatory markers
Description
Exercise training associated with inspiratory muscle training will reduces blood inflammatory markers
Time Frame
4 months
Title
Muscular evaluation
Description
Exercise training associated with inspiratory muscle training will increase skeletal muscle strength
Time Frame
4 months
Title
Respiratoy muscle function
Description
Exercise training associated with inspiratory muscle training will increase inspitarory muscle strength and endurance.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Eduardo Negrão
Organizational Affiliation
InCor, HCFMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Coração - HC/FMUSP
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31743617
Citation
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.
Results Reference
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Exercise Training Associated With Inspiratory Muscle Training in Heart Failure

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