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Inspiratory Muscle Training in Patients With Autonomic Neuropathic

Primary Purpose

Diabetes Mellitus, Diabetic Autonomic Neuropathy

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle training (IMT)
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Autonomic Neuropathy, Inspiratory Muscle training

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institudo de Cardiologia do Rio Grande do SulRecruiting

Outcomes

Primary Outcome Measures

Inspiratory muscle strength

Secondary Outcome Measures

Variability of heart rate

Full Information

First Posted
September 12, 2008
Last Updated
September 15, 2008
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT00752440
Brief Title
Inspiratory Muscle Training in Patients With Autonomic Neuropathic
Official Title
Inspiratory Muscle Training in Patients With Autonomic Neuropathic: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2008 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Autonomic Neuropathy
Keywords
Diabetes Mellitus, Autonomic Neuropathy, Inspiratory Muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training (IMT)
Other Intervention Name(s)
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.
Intervention Description
IMT (30 min 7 times per week, for 8 weeks)
Primary Outcome Measure Information:
Title
Inspiratory muscle strength
Time Frame
eight
Secondary Outcome Measure Information:
Title
Variability of heart rate
Time Frame
eight

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatriz D Schaan, MD, ScD
Phone
555132303600
Ext
3757
Email
beatrizschann@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz D Schann, MD, ScD
Organizational Affiliation
Institudo de cardiologia de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institudo de Cardiologia do Rio Grande do Sul
City
Porto Alegre
State/Province
RGS
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz D Schann, MD, ScD
Phone
555132303600
Ext
3757
Email
beatrizschann@gmail.com

12. IPD Sharing Statement

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Inspiratory Muscle Training in Patients With Autonomic Neuropathic

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