Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness

Not Applicable

Completed

• Conditions: Diabetes Complications; Inspiratory Muscle Weakness
• Interventions: Behavioral: Inspiratory muscle training; Behavioral: Inpiratory muscle training placebo

• Registration Number: NCT00815178
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

The purpose of the study is to determine if inspiratory muscle training improves inspiratory muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.

Detailed Description

In congestive heart failure patients, inspiratory muscle weakness can be reversed by developing diaphragmatic hypertrophy through inspiratory muscle training, improving functional capacity and quality of life. In type 2 diabetes mellitus patients the frequency of inspiratory muscle weakness is unknown, as well as the response to inspiratory muscle training. For this reason, the present study evaluated the inspiratory muscle strength in type 2 diabetes mellitus patients and the effect of inspiratory muscle training on inspiratory muscle strength, pulmonary function, functional capacity and autonomic modulation assessed through heart rate variability.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-12
• Study First Submitted: 2008-12-26
• Study First Submitted QC: 2008-12-26
• Last Update Submitted: 2008-12-26
• Study First Posted: 2008-12-29
• Last Update Posted: 2008-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• diabetes melittus
• sedentary
• inspiratory muscle weakness with PImax < 70% of the predicted

Exclusion Criteria

• mass index > 33 kg/m2
• exercise-induced asthma history
• infectious disease
• osteoarticular disease
• regular alcohol or tobacco consumption in the past 6 months
• cardiac disease
• pulmonary disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle training	Inspiratory muscle training	-
Placebo	Inpiratory muscle training placebo	-

Primary Outcome Measures

Name	Time	Method
Maximum inspiratory pressure	8 weeks

Secondary Outcome Measures

Name	Time	Method
Peak exercise oxigen consumption	8 weeks
pulmonary function	8 weeks
autonomic modulation assessed by heart rate variability	8 weeks

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil