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NCT00752440 Clinical Trial

Inspiratory Muscle Training in Patients With Autonomic Neuropathic

Diabetes Mellitus Clinical Trial

Official title:
Inspiratory Muscle Training in Patients With Autonomic Neuropathic: a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00752440
Other study ID # 3865/06
Secondary ID
Status Recruiting
Phase Phase 4
First received September 12, 2008
Last updated September 15, 2008
Start date August 2006
Est. completion date July 2009

Study information
Verified date September 2008
Source Instituto de Cardiologia do Rio Grande do Sul
Contact Beatriz D Schaan, MD, ScD
Phone 555132303600
Email beatrizschann@gmail.com
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date July 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Inspiratory muscle training (IMT)
IMT (30 min 7 times per week, for 8 weeks)

Locations
Country Name City State
Brazil Institudo de Cardiologia do Rio Grande do Sul Porto Alegre RGS

Sponsors (1)
Lead Sponsor Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inspiratory muscle strength eight Yes
Secondary Variability of heart rate eight Yes
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