Inspiratory Muscle Training in Patients With Autonomic Neuropathic
Inspiratory Muscle Training in Patients With Autonomic Neuropathic
November 9, 2008
clinicaltrials.gov
This study is currently recruiting participants.
Verified by Instituto de Cardiologia do Rio Grande do Sul, September 2008
Sponsored by: Instituto de Cardiologia do Rio Grande do Sul
Information provided by: Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT00752440
Purpose
This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy.
Condition Intervention Phase
Diabetes Mellitus
Diabetic Autonomic Neuropathy
Other: Inspiratory muscle training (IMT)
Phase IV
MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Inspiratory Muscle Training in Patients With Autonomic Neuropathic: a Randomized Trial
Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:
Primary Outcome Measures:
Inspiratory muscle strength [ Time Frame: eight ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Variability of heart rate [ Time Frame: eight ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 24
Study Start Date: August 2006
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
Other: Inspiratory muscle training (IMT)
IMT (30 min 7 times per week, for 8 weeks)
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.
Eligibility
Ages Eligible for Study: 35 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752440
Contacts
Contact: Beatriz D Schaan, MD, ScD 555132303600 ext 3757
Locations
Brazil, RGS
Institudo de Cardiologia do Rio Grande do Sul Recruiting
Porto Alegre, RGS, Brazil
Contact: Beatriz D Schann, MD, ScD 555132303600 ext 3757 beatrizschann@gmail.com
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Investigators
Principal Investigator: Beatriz D Schann, MD, ScD Institudo de cardiologia de Porto Alegre
More Information
Responsible Party: Beatriz Schann ( Organization: Intituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia )
Study ID Numbers: 3865/06
First Received: September 12, 2008
Last Updated: September 15, 2008
ClinicalTrials.gov Identifier: NCT00752440
Health Authority: Brazil: National Committee of Ethics in Research
Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
Diabetes Mellitus
Autonomic Neuropathy
Inspiratory Muscle training
Study placed in the following topic categories:
Metabolic Diseases
Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Diabetes Complications
Additional relevant MeSH terms:
Nervous System Diseases
Votes:27
Comments: 0