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Exercise Training Associated With Inspiratory Muscle Training in Heart Failure

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01747395
Collaborator
Federal University of São Paulo (Other)
40
Enrollment
1
Location
4
Arms
107
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise training
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Aerobic Exercise Training Associated With Inspiratory Muscle Training in Patients With Heart Failure
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

No exercise group (sedentary)
Experimental: Aerobic Exercise Training

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

Other: Exercise training
The heart failure patients are subjected to differents protocols of physical training
Experimental: Inspiratory Muscle Training

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

Other: Exercise training
The heart failure patients are subjected to differents protocols of physical training
Experimental: Aerobic+Inspiratory Muscle Training

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

Outcome Measures

Primary Outcome Measures

  1. Autonomic control [4 months]

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

Secondary Outcome Measures

  1. Functional Capacity [4 months]

    Exercise training associated with inspiratory muscle training will improve peak oxygen consumption

  2. Quality of life [4 months]

    Exercise training associated with inspiratory muscle training will improve quality of life

  3. Blood inflammatory markers [4 months]

    Exercise training associated with inspiratory muscle training will reduces blood inflammatory markers

  4. Muscular evaluation [4 months]

    Exercise training associated with inspiratory muscle training will increase skeletal muscle strength

  5. Respiratoy muscle function [4 months]

    Exercise training associated with inspiratory muscle training will increase inspitarory muscle strength and endurance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto do Coração - HC/FMUSP São Paulo SP Brazil

Sponsors and Collaborators

  • University of Sao Paulo General Hospital
  • Federal University of São Paulo

Investigators

  • Principal Investigator: Carlos Eduardo Negrão, InCor, HCFMUSP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patricia Fernandes Trevizan, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01747395
Other Study ID Numbers:
  • ICRESP814/10
First Posted:
Dec 11, 2012
Last Update Posted:
Apr 30, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Patricia Fernandes Trevizan, PhD, University of Sao Paulo General Hospital
Heart Failure
Exercise and Physical Fitness
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Apr 30, 2021