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
Recruitment status was Recruiting
Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
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
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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:
Detailed Description:
-
Other: Inspiratory muscle training (IMT)
- 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.
IMT (30 min 7 times per week, for 8 weeks)
Other Names:
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 | 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:
|
Respiratory Aspiration Diabetes Mellitus Nervous System Diseases Diabetic Neuropathies Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Diabetes Complications |
ClinicalTrials.gov processed this record on May 21, 2013