IMT in Ventilatory Muscle Metaboreflex in COPD

December 2, 2015 updated by: Danilo C Berton, Federal University of Rio Grande do Sul

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

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
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inspiratory Muscle Training (IMT)
Patients from the inspiratory muscle training group will utilize a linear pressoric resistance equipment with an inspiratory charge of 30% of maximum inspiratory pressure (adjusted weekly), during 7 days of the week, session duration of 30 minutes, during 8 weeks.
Other: Inspiratory Muscle Training
Patients will receive IMT for 30 min, 7 times per week, for 8 weeks using Inspiratory Muscle Trainer device (PowerBreath Inc.). During training, patients will be instructed to maintain diaphragmatic breathing, with a breathing rate at 15 to 20 breaths/min. Inspiratory load was set at 30% of maximal static inspiratory pressure, and weekly training loads were adjusted to maintain 30% of the PImax. Each week, six training sessions were performed at home and one training session was supervised at the hospital.
Placebo Comparator: Sham IMT
Patients in the placebo group will be submitted to inspiratory muscle training with the same equipment as the intervention group, however without a resistance generating spring.
Other: SHAM
Patients will receive SHAM training for 30 min, 7 times per week, for 8 weeks using Inspiratory Muscle Trainer device (PowerBreath Inc.) without load. Patients will be instructed to maintain diaphragmatic breathing, with a breathing rate at 15 to 20 breaths/min. Each week, six training sessions were performed at home and one training session was supervised at the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Calf blood flow
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to exercise tolerance (tlim)
Time Frame: 8 weeks
Exercise time during high intensity submaximal Cardiopulmonary exercise testing
8 weeks
Maximum Inspiratory Pressure
Time Frame: 8 weeks
8 weeks
The St George's Respiratory Questionnaire
Time Frame: 8 weeks
8 weeks
Baseline Dyspnea Index/Transitional Dyspnea Index
Time Frame: 8 weeks
8 weeks
Calf vascular resistance
Time Frame: 8 weeks
Calf blood flow/mean arterial pressure
8 weeks

Collaborators and Investigators

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

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Danilo C Berton, PhD, Hospital de Clinicas de Porto Alegre

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

June 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 15, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimate)

September 18, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120489

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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