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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Inspiratory Muscle Training in Patients With Autonomic Neuropathic: a Randomized Trial

Resource links provided by NLM:


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)
    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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752440

Contacts
Contact: Beatriz D Schaan, MD, ScD 555132303600 ext 3757 beatrizschann@gmail.com

Locations
Brazil
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

No publications provided

Responsible Party: Organization: Intituto de Cardiologia do Rio Grande do Sul/ Fundação Universitária de Cardiologia, Beatriz Schann
ClinicalTrials.gov Identifier: NCT00752440     History of Changes
Other Study ID Numbers: 3865/06
Study First Received: September 12, 2008
Last Updated: September 15, 2008
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Neuropathies
Nervous System Diseases
Respiratory Aspiration
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014