Inspiratory Muscle Training in Patients With Autonomic Ne... | NCT00752440

Studies
Inspiratory Muscle Training in Patients With Autonomic Neuropathic

NCT00752440

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Status

Unknown status

Last Update Posted

Sep 16, 2008Estimated

Enrollment

24Estimated

Phase

Phase 4

Conditions

Diabetes Mellitus
Diabetic Autonomic Neuropathy

Interventions

Inspiratory muscle training (IMT)

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Nov 2008Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Sep 12, 2008

First Submission Date that Met QC Criteria

Sep 12, 2008

First Posted Date

Sep 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2008

Last Update Posted Date

Sep 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Inspiratory muscle training (IMT)	Other	IMT (30 min 7 times per week, for 8 weeks)		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.

Measure	Description	Time Frame
Inspiratory muscle strength		eight

Measure	Description	Time Frame
Variability of heart rate		eight

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Beatriz D Schaan, MD, ScD	Contact	555132303600	3757	beatrizschann@gmail.com

Overall Officials

Name	Affiliation	Role
Beatriz D Schann, MD, ScD	Institudo de cardiologia de Porto Alegre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institudo de Cardiologia do Rio Grande do Sul	Recruiting	Porto Alegre	RGS		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003929	Diabetic Neuropathies

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014797	Vital Capacity
D005541	Forced Expiratory Volume

Ancestor Terms

ID	Term
D014109	Total Lung Capacity
D008176	Lung Volume Measurements
D012129	Respiratory Function Tests
D003948	Diagnostic Techniques, Respiratory System

Browse Leaves

Not provided

Browse Branches

Not provided