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Inspiratory Muscle Training Effectiveness in Sympathetic Activity and Functional Capacity in Patients With Heart Failure

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Myocardial scintigraphy
Cardiopulmonary test
AVD-Glittre Test
Diaphragm ultrasound
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Heart Failure;
  • Lower left ventricular ejection fraction 45% (LVEF <45%) assessed by simple and recent echocardiogram;
  • Functional Class II and III by the New York Heart Association (NYHA)
  • Clinically stable;
  • Ex-smokers over five years;
  • Maximal inspiratory pressure (MIP) <70% of predicted;
  • Forced expiratory volume/Forced vital capacity (FEV1 / FVC) > 70% of predicted;

Exclusion Criteria:

  • Unstable angina;
  • Myocardial infarction and heart surgery up to three months before the survey;
  • Chronic respiratory diseases;
  • Hemodynamic instability;
  • Trauma recent face, nausea and vomiting.
  • Orthopedic and neurological diseases that may preclude the achievement of the cardiopulmonary test and Cardiac Rehabilitation exercises;
  • Psychological and / or cognitive impairments that restrict them to respond to questionnaires;

Sites / Locations

  • Physiology laboratory and cardiopulmonary physiotherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Sympathetic myocardial activity after IMT

Maximal functional capacity after IMT

submaximal functional capacity after IMT

Thickness and mobility of the diaphragm after IMT

Arm Description

Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the modulation of sympathetic myocardial activity of patients with HF

Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the maximal functional capacity of patients with HF

Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the submaximal functional capacity of patients with HF

Assess the impact of Inspiratory Muscle Training in combination with a cardiac rehabilitation program on the thickness and mobility of the diaphragm in patients with heart failure.

Outcomes

Primary Outcome Measures

Adrenergic tone of the heart muscle
Measured by the integrity and activity of the sympathetic nervous pre synaptic terminals.
Change from Functional capacity
Measured by cardiopulmonary exercise testing

Secondary Outcome Measures

Change from Submaximal functional capacity
Measured by Glittre Test
Mobility of the diaphragm
Reviewed from the ultrasound
Diaphragm thickness
Reviewed from the ultrasound

Full Information

First Posted
November 4, 2015
Last Updated
October 27, 2019
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02600000
Brief Title
Inspiratory Muscle Training Effectiveness in Sympathetic Activity and Functional Capacity in Patients With Heart Failure
Official Title
Effectiveness of Inspiratory Muscle Training Associated With a Cardiac Rehabilitation Program in Sympathetic Activity and Functional Capacity in Patients With Heart Failure: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Heart failure (HF) is configured major problem for public health in the country. Affected individuals may experience fatigue, dyspnea, respiratory muscle weakness, overstimulation of the sympathetic myocardial activity, among others. In relation to the treatment of patients with heart failure with symptoms mentioned above a great alternative is the implantation of cardiac rehabilitation programs, these programs can also be associated with other muscle training measures, among these there is inspiratory muscle training (IMT), as the weakness of these muscles is rather found in this population and this directly related to signs and symptoms. OBJECTIVE: To evaluate the efficacy of inspiratory muscle training associated with a cardiac rehabilitation program in the modulation of sympathetic myocardial activity and maximal and submaximal functional capacity of patients with HF between 21-60 years. METHODOLOGY: This is a clinical trial, controlled, randomized, double-blind being developed in partnership with the Department of Physical Therapy, Federal University of Pernambuco (UFPE) and the Hospital das Clinicas (HC) of Pernambuco, whose patients will be accrued on the Recife's main referral centers in caring for patients with heart failure. Patients will undergo the evaluation of pulmonary function and respiratory muscle strength (spirometry and digital Manovacuometry) as well as on the functional capacity (Ergospirometry), cardiac innervation (myocardial scintigraphy), mobility and diaphragm thickness (ultrasound) and quality of life. After the evaluation will be randomly allocated into two groups: The control group will perform cardiac rehabilitation associated with the Sham of IMT, and the experimental group cardiac rehabilitation associated with the IMT at 30% of maximal inspiratory pressure. The intervention will last three months for both groups and after this phase patients will be submitted again to the assessment tools. EXPECTED RESULTS: To clarify the association between physical exercise associated with specific respiratory training in modulating the autonomic nervous system of patients with HF and what the relationship with reflected cardiorespiratory fitness in maximal and submaximal functional capacity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sympathetic myocardial activity after IMT
Arm Type
Experimental
Arm Description
Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the modulation of sympathetic myocardial activity of patients with HF
Arm Title
Maximal functional capacity after IMT
Arm Type
Experimental
Arm Description
Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the maximal functional capacity of patients with HF
Arm Title
submaximal functional capacity after IMT
Arm Type
Experimental
Arm Description
Evaluate the effectiveness of Muscle Training Inspiratory associated with a cardiac rehabilitation program in the submaximal functional capacity of patients with HF
Arm Title
Thickness and mobility of the diaphragm after IMT
Arm Type
Experimental
Arm Description
Assess the impact of Inspiratory Muscle Training in combination with a cardiac rehabilitation program on the thickness and mobility of the diaphragm in patients with heart failure.
Intervention Type
Radiation
Intervention Name(s)
Myocardial scintigraphy
Intervention Description
Myocardial scintigraphy with Iodo123-Metaiodobenzylguanidine (MIBG) to assess the Sympathetic myocardial activity
Intervention Type
Device
Intervention Name(s)
Cardiopulmonary test
Intervention Description
Assessment of maximal functional capacity
Intervention Type
Device
Intervention Name(s)
AVD-Glittre Test
Intervention Description
Evaluation of submaximal functional capacity after inspiratory muscle training.
Intervention Type
Device
Intervention Name(s)
Diaphragm ultrasound
Intervention Description
Evaluation of thickness and diaphragmatic mobility
Primary Outcome Measure Information:
Title
Adrenergic tone of the heart muscle
Description
Measured by the integrity and activity of the sympathetic nervous pre synaptic terminals.
Time Frame
Change from Baseline and Three months after
Title
Change from Functional capacity
Description
Measured by cardiopulmonary exercise testing
Time Frame
Change from Baseline and Three months after
Secondary Outcome Measure Information:
Title
Change from Submaximal functional capacity
Description
Measured by Glittre Test
Time Frame
Change from Baseline and Three months after
Title
Mobility of the diaphragm
Description
Reviewed from the ultrasound
Time Frame
Change from Baseline and Three months after
Title
Diaphragm thickness
Description
Reviewed from the ultrasound
Time Frame
Change from Baseline and Three months after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Heart Failure; Lower left ventricular ejection fraction 45% (LVEF <45%) assessed by simple and recent echocardiogram; Functional Class II and III by the New York Heart Association (NYHA) Clinically stable; Ex-smokers over five years; Maximal inspiratory pressure (MIP) <70% of predicted; Forced expiratory volume/Forced vital capacity (FEV1 / FVC) > 70% of predicted; Exclusion Criteria: Unstable angina; Myocardial infarction and heart surgery up to three months before the survey; Chronic respiratory diseases; Hemodynamic instability; Trauma recent face, nausea and vomiting. Orthopedic and neurological diseases that may preclude the achievement of the cardiopulmonary test and Cardiac Rehabilitation exercises; Psychological and / or cognitive impairments that restrict them to respond to questionnaires;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniella C Brandão, Doctor
Phone
+55 81 998036255
Email
daniellacunha@hotmail.com
Facility Information:
Facility Name
Physiology laboratory and cardiopulmonary physiotherapy
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica C Leite, graduate
Phone
+55 83 988667323
Email
jesewev@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32532283
Citation
Leite JC, Brandao DC, Brandao SCS, Fuzari HKB, Vidal TM, Frutuoso J, Remigio MI, de Araujo BTS, Campos SL, Dornelas de Andrade A. Effectiveness of inspiratory muscle training associated with a cardiac rehabilitation program on sympathetic activity and functional capacity in patients with heart failure: a study protocol for a randomized controlled trial. Trials. 2020 Jun 12;21(1):519. doi: 10.1186/s13063-020-04363-6.
Results Reference
derived

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Inspiratory Muscle Training Effectiveness in Sympathetic Activity and Functional Capacity in Patients With Heart Failure

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