IMT in Ventilatory Muscle Metaboreflex in COPD

NCT01945398 | Completed

• 1 other identifier: 120489
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary Rehabilitation; Inspiratory Muscle Training; Inspiratory Muscle Strength; Vascular Resistance; Exercise; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Calf blood flow

  8 weeks

Secondary Outcomes (5)

• Time to exercise tolerance (tlim)

  8 weeks

• Maximum Inspiratory Pressure

  8 weeks

• The St George's Respiratory Questionnaire

  8 weeks

• Baseline Dyspnea Index/Transitional Dyspnea Index

  8 weeks

• Calf vascular resistance

  8 weeks

Study Arms (2)

Inspiratory Muscle Training (IMT)

EXPERIMENTAL

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.

Other: Inspiratory Muscle Training

Sham IMT

PLACEBO COMPARATOR

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.

Other: SHAM

Interventions

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.

Inspiratory Muscle Training (IMT)

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.

Sham IMT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those selected must be classified as GOLD II-IV, with moderate to severe expiratory flow obstruction.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Hospital de Clinicas de Porto Alegre: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

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

Location

Related Publications (34)

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  BACKGROUND

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Study Officials

• Danilo C Berton, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 15, 2013
• First Posted: September 18, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

BR (1)