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Inspiratory Muscle Training in Patients With Autonomic Neuropathic

NCT ID: NCT00752440

Last Updated: 2008-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus Diabetic Autonomic Neuropathy

Keywords

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Diabetes Mellitus Autonomic Neuropathy Inspiratory Muscle training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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Inspiratory muscle training (IMT)

IMT (30 min 7 times per week, for 8 weeks)

Intervention Type OTHER

Other Intervention Names

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Diabetic autonomic neuropathy; Inspiratory muscle function testing; forced vital capacity and forced expiratory volume; Maximal functional capacity with incremental exercise test; variability of the heart frequency.

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Beatriz Schann

Principal Investigators

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Beatriz D Schann, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

Institudo de cardiologia de Porto Alegre

Locations

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Institudo de Cardiologia do Rio Grande do Sul

Porto Alegre, RGS, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Beatriz D Schaan, MD, ScD

Role: CONTACT

Phone: 555132303600

Email: [email protected]

Facility Contacts

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Beatriz D Schann, MD, ScD

Role: primary

Other Identifiers

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3865/06

Identifier Type: -

Identifier Source: org_study_id