IMT in Ventilatory Muscle Metaboreflex in COPD

N/ACompletedNCT01945398

Federal University of Rio Grande do Sul13 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Inspiratory Muscle TrainingOTHER

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.

SHAMOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Calf blood flow

Time frame: 8 weeks

Secondary Outcomes

Time to exercise tolerance (tlim)

Exercise time during high intensity submaximal Cardiopulmonary exercise testing

Time frame: 8 weeks

Maximum Inspiratory Pressure

Time frame: 8 weeks

The St George's Respiratory Questionnaire

Time frame: 8 weeks

Baseline Dyspnea Index/Transitional Dyspnea Index

Time frame: 8 weeks

Calf vascular resistance

Calf blood flow/mean arterial pressure

Time frame: 8 weeks

Data from ClinicalTrials.gov

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