Full Text View
Tabular View
No Study Results Posted
Related Studies
The Effects of the Inspiratory Muscle Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients.
This study is currently recruiting participants.
Verified by Hospital de Clinicas de Porto Alegre, March 2008
First Received: March 6, 2008   No Changes Posted
Sponsored by: Hospital de Clinicas de Porto Alegre
Information provided by: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00634296
  Purpose

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.


Condition Intervention
Heart Failure
Other: Inspiratory muscle added by aerobic to aerobic alone

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: March 2005
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
G2: Active Comparator
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634296

Contacts
Contact: Jorge P. Ribeiro, MD, ScD +55 51 9982 4984 jpribeiro@cpovo.net
Contact: Eliane R. Winkelmann, MS +55 55 9922 4402 elianew@unijui.edu.br

Locations
Brazil, RS
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Jorge P. Ribeiro, MD, ScD     +55 51 9982 4984     jpribeiro@cpovo.net    
Contact: Eliane Winkelmann, MS     +55 55 9922 4402     elianew@unijui.edu.br    
Principal Investigator: Jorge P. Ribeiro, MD, ScD            
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Jorge P. Ribeiro, MD, ScD Associate Professor and Chief of Non-invasive Cardiology
  More Information

No publications provided

Responsible Party: Hospital de Clínicas de Porto Alegre ( Jorge Pinto Ribeiro )
Study ID Numbers: HCPA2004-302
Study First Received: March 6, 2008
Last Updated: March 6, 2008
ClinicalTrials.gov Identifier: NCT00634296     History of Changes
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital de Clinicas de Porto Alegre:
Heart failure
Systolic dysfunction
Inspiratory muscle weakness

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Asthenia
Muscle Weakness

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009