- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00752440
Inspiratory Muscle Training in Patients With Autonomic Neuropathic
September 15, 2008 updated by: Instituto de Cardiologia do Rio Grande do Sul
Inspiratory Muscle Training in Patients With Autonomic Neuropathic: a Randomized Trial
This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Beatriz D Schaan, MD, ScD
- Phone Number: 3757 555132303600
- Email: beatrizschann@gmail.com
Study Locations
-
-
RGS
-
Porto Alegre, RGS, Brazil
- Recruiting
- Institudo de Cardiologia do Rio Grande do Sul
-
Contact:
- Beatriz D Schann, MD, ScD
- Phone Number: 3757 555132303600
- Email: beatrizschann@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inspiratory muscle strength
Time Frame: eight
|
eight
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Variability of heart rate
Time Frame: eight
|
eight
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Beatriz D Schann, MD, ScD, Institudo de cardiologia de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Anticipated)
November 1, 2008
Study Completion (Anticipated)
July 1, 2009
Study Registration Dates
First Submitted
September 12, 2008
First Submitted That Met QC Criteria
September 12, 2008
First Posted (Estimate)
September 15, 2008
Study Record Updates
Last Update Posted (Estimate)
September 16, 2008
Last Update Submitted That Met QC Criteria
September 15, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Endocrine System Diseases
- Diabetes Complications
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Diabetes Mellitus
- Respiratory Aspiration
- Diabetic Neuropathies
Other Study ID Numbers
- 3865/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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