Clinical trial NCT01945398: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary Rehabilitation
Inspiratory Muscle Training
Inspiratory Muscle Strength
Vascular Resistance
Exercise
Chronic Obstructive Pulmonary Disease
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
First posted: 2013-09-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Calf blood flow
timeFrame: 8 weeks
Secondary outcomes:
measure: Time to exercise tolerance (tlim)
timeFrame: 8 weeks
measure: Maximum Inspiratory Pressure
timeFrame: 8 weeks
measure: The St George's Respiratory Questionnaire
timeFrame: 8 weeks
measure: Baseline Dyspnea Index/Transitional Dyspnea Index
timeFrame: 8 weeks
measure: Calf vascular resistance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Danilo C Berton, PhD
role: PRINCIPAL_INVESTIGATOR
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