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The Effects of the Inspiratory Muscle Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients.

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle added by aerobic to aerobic alone
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Systolic dysfunction, Inspiratory muscle weakness

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • previous history of symptomatic heart failure caused by left ventricular systolic dysfunction
  • inspiratory muscle weakness (PImax < 70% of the predicted)
  • clinical stability, including no change in medications for the past three months

Exclusion Criteria:

  • unstable angina
  • myocardial infarction, or cardiac surgery within the previous three months
  • chronic metabolic, orthopedic, or infectious diseases
  • treatments with steroids, hormones, or cancer chemotherapy
  • history of exercise-induced asthma, chronic obstructive pulmonary disease
  • smokers

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

G2

Arm Description

Inspiratory muscle training added by aerobic training to aerobic training alone

Outcomes

Primary Outcome Measures

To compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness.

Secondary Outcome Measures

To compare effects between the training groups evaluating strength and endurance of inspiratory muscles; functional capacity; the physical and psychological perceptions of quality of life and heart rate variability and sleep apnea.

Full Information

First Posted
March 6, 2008
Last Updated
March 6, 2008
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT00634296
Brief Title
The Effects of the Inspiratory Muscle Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients.
Official Title
The Effects of the Inspiratory Muscle Training Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients With Inspiratory Muscle Weakness.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness. To do so, strength and endurance of inspiratory muscles, functional capacity, quality of life, heart rate variability and sleep apnea evaluations will be conducted in patients with heart failure.
Detailed Description
A sample comprising at least 30 individuals is necessary. These subjects will be randomized in two groups, one consisting of inspiratory muscle training plus aerobic training, whereas the other will consist of the aerobic training alone. This prospective, randomized, controlled trial will include patients with the diagnosis of chronic heart failure attributable to left ventricular systolic dysfunction who will be recruited from the Heart Failure Clinic. Entry criteria for the study are a previous history of symptomatic heart failure caused by left ventricular systolic dysfunction, inspiratory muscle weakness (PImax < 70% of the predicted), and clinical stability, including no change in medications for the past three months. Exclusion criteria will be unstable angina, myocardial infarction, or cardiac surgery within the previous three months, chronic metabolic, orthopedic, or infectious diseases, treatments with steroids, hormones, or cancer chemotherapy, history of exercise-induced asthma, chronic obstructive pulmonary disease and smokers will be not recruited. The protocol was approved by the Committee for Ethics in Research of Hospital de Clinics de Porto Alegre and Ijuí University and all subjects are required to sign an informed consent form. Variables will be measured by strength and endurance (progressive and constant load), 6-min walk test, cardiopulmonary exercise testing, quality of life questionnaire, evaluation of the heart rate variability and sleep apnea. The inspiratory muscle training plus aerobic training will consist of cycle exercise (3 sessions/week) and inspiratory exercise by using Threshold equipment for 30 min, 7 times per week, whereas aerobic training group will perform only cycle exercise. Both treatments will last 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Systolic dysfunction, Inspiratory muscle weakness

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
G2
Arm Type
Active Comparator
Arm Description
Inspiratory muscle training added by aerobic training to aerobic training alone
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle added by aerobic to aerobic alone
Other Intervention Name(s)
Aerobic: G1, Inspiratory muscle added by aerobic: G2
Intervention Description
Inspiratory muscle added by aerobic to aerobic alone
Primary Outcome Measure Information:
Title
To compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness.
Time Frame
one year
Secondary Outcome Measure Information:
Title
To compare effects between the training groups evaluating strength and endurance of inspiratory muscles; functional capacity; the physical and psychological perceptions of quality of life and heart rate variability and sleep apnea.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: previous history of symptomatic heart failure caused by left ventricular systolic dysfunction inspiratory muscle weakness (PImax < 70% of the predicted) clinical stability, including no change in medications for the past three months Exclusion Criteria: unstable angina myocardial infarction, or cardiac surgery within the previous three months chronic metabolic, orthopedic, or infectious diseases treatments with steroids, hormones, or cancer chemotherapy history of exercise-induced asthma, chronic obstructive pulmonary disease smokers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge P. Ribeiro, MD, ScD
Phone
+55 51 9982 4984
Email
jpribeiro@cpovo.net
First Name & Middle Initial & Last Name or Official Title & Degree
Eliane R. Winkelmann, MS
Phone
+55 55 9922 4402
Email
elianew@unijui.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge P. Ribeiro, MD, ScD
Organizational Affiliation
Associate Professor and Chief of Non-invasive Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge P. Ribeiro, MD, ScD
Phone
+55 51 9982 4984
Email
jpribeiro@cpovo.net
First Name & Middle Initial & Last Name & Degree
Eliane Winkelmann, MS
Phone
+55 55 9922 4402
Email
elianew@unijui.edu.br
First Name & Middle Initial & Last Name & Degree
Jorge P. Ribeiro, MD, ScD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19853695
Citation
Winkelmann ER, Chiappa GR, Lima CO, Viecili PR, Stein R, Ribeiro JP. Addition of inspiratory muscle training to aerobic training improves cardiorespiratory responses to exercise in patients with heart failure and inspiratory muscle weakness. Am Heart J. 2009 Nov;158(5):768.e1-7. doi: 10.1016/j.ahj.2009.09.005. Epub 2009 Oct 2.
Results Reference
derived

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The Effects of the Inspiratory Muscle Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients.

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