Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by:
Faculdade Evangelica do Parana
ClinicalTrials.gov Identifier:
NCT01056081
First received: January 22, 2010
Last updated: January 25, 2010
Last verified: March 2006
  Purpose

Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary disease. In this study the investigators investigate whether IMT associated with exercise training would be better than exercise training alone, with regard to exercise capacity, inspiratory muscle strength and dyspnea.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Other: Inspiratory muscle training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disease Undergoing a Pulmonary Rehabilitation Program

Resource links provided by NLM:


Further study details as provided by Faculdade Evangelica do Parana:

Primary Outcome Measures:
  • Inspiratory muscle strength [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Dyspnea [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inspiratory muscle training

The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA).

The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training.

Other: Inspiratory muscle training

The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA).

The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training.

Other Name: IMT

Detailed Description:

Study design: A double-blind parallel controlled trial Setting: outpatient clinic Inclusion criteria: Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program, with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).

Outcome measurements: Inspiratory muscle strength (using maximal inspiratory pressure, MIP), exercise capacity (using six-minute walk test) and dyspnea were measured.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
  • In a stable condition (without exacerbations or infections for at least a month)
  • Had to be former smokers (> 6 months without smoking)
  • subjects referred by a physician to the Pulmonary Rehabilitation Program

Exclusion Criteria:

  • Subjects with a known history of asthma, or severe and/or unstable heart disease or any other pathological condition that could impair their physical activities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056081

Sponsors and Collaborators
Faculdade Evangelica do Parana
Investigators
Study Chair: Silvia R Valderramas, PhD Evangelical Faculty of Paraná
  More Information

No publications provided

Responsible Party: Silvia Valderramas, Faculdade Evangélica do Paraná
ClinicalTrials.gov Identifier: NCT01056081     History of Changes
Other Study ID Numbers: FEPAR 1768
Study First Received: January 22, 2010
Last Updated: January 25, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Faculdade Evangelica do Parana:
COPD
inspiratory muscles
diaphragm

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014