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

March 6, 2008 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge P. Ribeiro, MD, ScD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: G2
Inspiratory muscle training added by aerobic training to aerobic training alone
Other: Inspiratory muscle added by aerobic to aerobic alone
Inspiratory muscle added by aerobic to aerobic alone
Other Names:
  • Aerobic: G1
  • Inspiratory muscle added by aerobic: G2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Jorge P. Ribeiro, MD, ScD, Associate Professor and Chief of Non-invasive Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Anticipated)

March 1, 2008

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 13, 2008

Last Update Submitted That Met QC Criteria

March 6, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCPA2004-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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