IMT in Ventilatory Muscle Metaboreflex in COPD

Federal University of Rio Grande do Sul

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: SHAM; Other: Inspiratory Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01945398

120489

Details and patient eligibility

About

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).

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups, including a placebo group

Inspiratory Muscle Training (IMT)

Experimental group

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.

Treatment:

Other: Inspiratory Muscle Training

Sham IMT

Placebo Comparator group

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.

Treatment:

Other: SHAM