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IMT in Ventilatory Muscle Metaboreflex in COPD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01945398
Enrollment
13
Registered
2013-09-18
Start date
2013-06-30
Completion date
2015-02-28
Last updated
2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

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.

Interventions

OTHERInspiratory Muscle Training

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.

OTHERSHAM

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.

Sponsors

Hospital de Clinicas de Porto Alegre
CollaboratorOTHER
Federal University of Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Calf blood flow8 weeks

Secondary

MeasureTime frameDescription
Time to exercise tolerance (tlim)8 weeksExercise time during high intensity submaximal Cardiopulmonary exercise testing
Maximum Inspiratory Pressure8 weeks
The St George's Respiratory Questionnaire8 weeks
Baseline Dyspnea Index/Transitional Dyspnea Index8 weeks
Calf vascular resistance8 weeksCalf blood flow/mean arterial pressure

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026