Skip to main content
OpenTrials
Completed

NCT Number: NCT01945398

IMT in Ventilatory Muscle Metaboreflex in COPD

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

Other

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.

SHAM

Other

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 outcomes

  1. Calf blood flow

    Time frame: 8 weeks

Secondary outcomes

  1. Time to exercise tolerance (tlim)

    Time frame: 8 weeks

    Exercise time during high intensity submaximal Cardiopulmonary exercise testing

  2. Maximum Inspiratory Pressure

    Time frame: 8 weeks

  3. The St George's Respiratory Questionnaire

    Time frame: 8 weeks

  4. Baseline Dyspnea Index/Transitional Dyspnea Index

    Time frame: 8 weeks

  5. Calf vascular resistance

    Time frame: 8 weeks

    Calf blood flow/mean arterial pressure

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Collaborators

  • Hospital de Clinicas de Porto Alegre

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 18, 2013
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.