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
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Autonomic Neuropathy, Inspiratory Muscle training
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)
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
NCT ID
NCT00752440
First Posted
September 12, 2008
Last Updated
September 15, 2008
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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
Learn more about this trial
Inspiratory Muscle Training in Patients With Autonomic Neuropathic
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