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Clinical Trials/NCT01945398
NCT01945398
Completed
Not Applicable

Effect of Inspiratory Muscle Training in the Ventilatory Muscle Metaboreflex in Chronic Obstructive Pulmonary Disease Patients.

Federal University of Rio Grande do Sul1 site in 1 country13 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Federal University of Rio Grande do Sul
Enrollment
13
Locations
1
Primary Endpoint
Calf blood flow
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This research intends to evaluate if inspiratory muscle training (IMT) reduces inspiratory muscle metaboreflex through the decrease of calf vascular resistance and increase of calf blood flow in Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description

Patients will be selected from the Hospital de Clinicas de Porto Alegre's COPD ambulatory, by convenience. Afterwards, patients will be submitted to pulmonary function test (spirometry) and cardiopulmonary exercise tests (incremental and submaximal), maximal inspiratory pressure evaluation and induction of the inspiratory muscle metaboreflex through venous occlusion plethysmography. Disease specific health related quality of life questionnaire (Saint George Respiratory Questionnaire) and daily life dyspnea questionnaire (Baseline Dyspnea Index and Transitional Dyspnea Index) will be administered at the first and last visit of each subject. Patients will undergo inspiratory muscle training for 30 minutes per day, 7 times a week, for 8 weeks, with Inspiratory Muscle Trainer device (PowerBreath Inc.). There will be a weekly follow up at the institution's Clinical Research Center, where maximal inspiratory pressure (PImax) and inspiratory training techniques will be reevaluated. After this period, tests of pulmonary function, questionnaires exercise tolerance and induction of the inspiratory muscle metaboreflex will be reevaluated.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
February 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Rio Grande do Sul
Responsible Party
Principal Investigator
Principal Investigator

Danilo C Berton

MD

Federal University of Rio Grande do Sul

Eligibility Criteria

Inclusion Criteria

  • Selection of subjects will be made through the Hospital de Clinicas de Porto Alegre Pneumology Service's COPD ambulatory. The inclusion criteria consist of -patients with COPD with functional confirmation through spirometry as by previously defined criteria.
  • Those selected must be classified as GOLD II-IV, with moderate to severe expiratory flow obstruction.

Exclusion Criteria

  • Patients will be considered ineligible for this study if they
  • develop COPD exacerbation 8 weeks prior to recruitment
  • if systemic corticosteroids are utilized (in the last three months)
  • if there is history of acute myocardial infarction (in the last three months)
  • if there is presence of neuromuscular disease
  • history of cardiovascular disease or active smoking (in the last 6 months)
  • clinical history of peripheral vascular disease and if age is equal or superior to 85 years

Outcomes

Primary Outcomes

Calf blood flow

Time Frame: 8 weeks

Secondary Outcomes

  • Time to exercise tolerance (tlim)(8 weeks)
  • Maximum Inspiratory Pressure(8 weeks)
  • The St George's Respiratory Questionnaire(8 weeks)
  • Calf vascular resistance(8 weeks)
  • Baseline Dyspnea Index/Transitional Dyspnea Index(8 weeks)

Study Sites (1)

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