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Inspiratory Muscle Training in Patients With Autonomic Neuropathic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00752440
Recruitment Status : Unknown
Verified September 2008 by Instituto de Cardiologia do Rio Grande do Sul.
Recruitment status was:  Recruiting
First Posted : September 15, 2008
Last Update Posted : September 16, 2008
Information provided by:
Instituto de Cardiologia do Rio Grande do Sul

Brief Summary:
This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Autonomic Neuropathy Other: Inspiratory muscle training (IMT) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Training in Patients With Autonomic Neuropathic: a Randomized Trial
Study Start Date : August 2006
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : July 2009

Intervention Details:
  • Other: Inspiratory muscle training (IMT)
    IMT (30 min 7 times per week, for 8 weeks)
    Other Names:
    • 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.

Primary Outcome Measures :
  1. Inspiratory muscle strength [ Time Frame: eight ]

Secondary Outcome Measures :
  1. Variability of heart rate [ Time Frame: eight ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00752440

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Contact: Beatriz D Schaan, MD, ScD 555132303600 ext 3757

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Institudo de Cardiologia do Rio Grande do Sul Recruiting
Porto Alegre, RGS, Brazil
Contact: Beatriz D Schann, MD, ScD    555132303600 ext 3757   
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
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Principal Investigator: Beatriz D Schann, MD, ScD Institudo de cardiologia de Porto Alegre
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Responsible Party: Organization: Intituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia, Beatriz Schann Identifier: NCT00752440    
Other Study ID Numbers: 3865/06
First Posted: September 15, 2008    Key Record Dates
Last Update Posted: September 16, 2008
Last Verified: September 2008
Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
Diabetes Mellitus
Autonomic Neuropathy
Inspiratory Muscle training
Additional relevant MeSH terms:
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Respiratory Aspiration
Diabetic Neuropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications