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Inspiratory Muscle Training in Patients With Autonomic Neuropathic

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Instituto de Cardiologia do Rio Grande do Sul.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00752440
First received: September 12, 2008
Last updated: September 15, 2008
Last verified: September 2008
History of Changes

September 12, 2008
September 15, 2008
August 2006
November 2008   (final data collection date for primary outcome measure)
Inspiratory muscle strength [ Time Frame: eight ] [ Designated as safety issue: Yes ]
Maximal static inspiratory pressure [ Time Frame: twelve months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00752440 on ClinicalTrials.gov Archive Site
Variability of heart rate [ Time Frame: eight ] [ Designated as safety issue: Yes ]
Analysis of heart rate variability (HRV) [ Time Frame: twelve months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Inspiratory Muscle Training in Patients With Autonomic Neuropathic
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Diabetic Autonomic Neuropathy
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
July 2009
November 2008   (final data collection date for primary outcome measure)

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)
Both
35 Years to 75 Years
No
Contact: Beatriz D Schaan, MD, ScD 555132303600 ext 3757 beatrizschann@gmail.com
Brazil
 
NCT00752440
3865/06
Yes
Organization: Intituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia, Beatriz Schann
Instituto de Cardiologia do Rio Grande do Sul
Not Provided
Principal Investigator: Beatriz D Schann, MD, ScD Institudo de cardiologia de Porto Alegre
Instituto de Cardiologia do Rio Grande do Sul
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP