Inspiratory Muscle Training in Patients With Autonomic Neuropathic

Phase 4

• Conditions: Diabetes Mellitus; Diabetic Autonomic Neuropathy

• Registration Number: NCT00752440
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

Brief Summary

This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy.

Detailed Description

The diabetic autonomic neuropathy (NAD) is a common complication of diabetes mellitus (DM), both of the type 1 diabetes mellitus (DM1) as of the type 2 diabetes mellitus (DM2). The results of this study, would help to reveal the degree of commitment generated by NAD in respiratory muscle strength, can also enable the development of a new therapeutic approach, such non-pharmacological (respiratory muscle training), with a view to improve the respiratory muscle strength and alleviate the autonomic dysfunction in these patients.

Study Timeline

• Study Start: 2006-08
• Status Verified: 2008-09
• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-15
• Last Update Submitted: 2008-09-15
• Last Update Posted: 2008-09-16
• Primary Completion: 2008-11
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Diabetic autonomic neuropathy
• Age between 36 and
• 70 years old and signed in informed consent form

Exclusion Criteria

• Presence of congestive heart failure
• Chronic obstructive pulmonary disease (FEV1 < 70% and/or FEV1%< 80
• Class II or III obesity (body mass index > 35)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Inspiratory muscle strength	eight

Secondary Outcome Measures

Name	Time	Method
Variability of heart rate	eight

Trial Locations

Locations (1)

Institudo de Cardiologia do Rio Grande do Sul; 🇧🇷 Porto Alegre, RGS, Brazil