Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness - Tabular View

Tracking Information
First Received Date ^ICMJE	December 26, 2008
Last Updated Date	December 26, 2008
Start Date ^ICMJE	September 2006
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 26, 2008)	Maximum inspiratory pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: December 26, 2008)	Peak exercise oxigen consumption [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] pulmonary function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] autonomic modulation assessed by heart rate variability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness
Official Title ^ICMJE	Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness: A Randomized, Controlled Clinical Trial
Brief Summary	The purpose of the study is to determine if inspiratory muscle training improves inspiratory muscle strength of type 2 diabetes mellitus patients with inspiratory muscle weakness.
Detailed Description	In congestive heart failure patients, inspiratory muscle weakness can be reversed by developing diaphragmatic hypertrophy through inspiratory muscle training, improving functional capacity and quality of life. In type 2 diabetes mellitus patients the frequency of inspiratory muscle weakness is unknown, as well as the response to inspiratory muscle training. For this reason, the present study evaluated the inspiratory muscle strength in type 2 diabetes mellitus patients and the effect of inspiratory muscle training on inspiratory muscle strength, pulmonary function, functional capacity and autonomic modulation assessed through heart rate variability.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Diabetes Complications Inspiratory Muscle Weakness
Intervention ^ICMJE	Behavioral: Inspiratory muscle training Behavioral: Inpiratory muscle training placebo
Study Arms / Comparison Groups
Publications *	Chiappa GR, Roseguini BT, Vieira PJ, Alves CN, Tavares A, Winkelmann ER, Ferlin EL, Stein R, Ribeiro JP. Inspiratory muscle training improves blood flow to resting and exercising limbs in patients with chronic heart failure. J Am Coll Cardiol. 2008 Apr 29;51(17):1663-71.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date	September 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: diabetes melittus sedentary inspiratory muscle weakness with PImax < 70% of the predicted Exclusion Criteria: mass index > 33 kg/m2 exercise-induced asthma history infectious disease osteoarticular disease regular alcohol or tobacco consumption in the past 6 months cardiac disease pulmonary disease
Gender	Both
Ages	40 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT ID ^ICMJE	NCT00815178
Responsible Party	Hospital de Clínicas de Porto Alegre
Study ID Numbers ^ICMJE	Inspiratory training diabetes
Study Sponsor ^ICMJE	Hospital de Clinicas de Porto Alegre
Collaborators ^ICMJE	Coordenação de aperfeiçoamento do pessoal de nível superior (CAPES)
Investigators ^ICMJE
Information Provided By	Hospital de Clinicas de Porto Alegre
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP