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IMT in Ventilatory Muscle Metaboreflex in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory Muscle Training
SHAM
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary Rehabilitation, Inspiratory Muscle Training, Inspiratory Muscle Strength, Vascular Resistance, Exercise, Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inspiratory Muscle Training (IMT)

Sham IMT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Calf blood flow

Secondary Outcome Measures

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

Full Information

First Posted
September 15, 2013
Last Updated
December 2, 2015
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01945398
Brief Title
IMT in Ventilatory Muscle Metaboreflex in COPD
Official Title
Effect of Inspiratory Muscle Training in the Ventilatory Muscle Metaboreflex in Chronic Obstructive Pulmonary Disease Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Pulmonary Rehabilitation, Inspiratory Muscle Training, Inspiratory Muscle Strength, Vascular Resistance, Exercise, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training (IMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham IMT
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
SHAM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Calf blood flow
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Time to exercise tolerance (tlim)
Description
Exercise time during high intensity submaximal Cardiopulmonary exercise testing
Time Frame
8 weeks
Title
Maximum Inspiratory Pressure
Time Frame
8 weeks
Title
The St George's Respiratory Questionnaire
Time Frame
8 weeks
Title
Baseline Dyspnea Index/Transitional Dyspnea Index
Time Frame
8 weeks
Title
Calf vascular resistance
Description
Calf blood flow/mean arterial pressure
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danilo C Berton, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

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IMT in Ventilatory Muscle Metaboreflex in COPD

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