Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00815178
First received: December 26, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted

December 26, 2008
December 26, 2008
September 2006
September 2008   (final data collection date for primary outcome measure)
Maximum inspiratory pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness
Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness: A Randomized, Controlled Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes Complications
  • Inspiratory Muscle Weakness
  • Behavioral: Inspiratory muscle training
    For Inspiratory muscle training (IMT)patients carried out the IMT on a daily basis for eight weeks, with duration of 30 minutes and intensity corresponding to 30% of resting PImax, with a linear pressure resistance device (Threshold®). Weekly maximum inspiratory pressure (PImax) evaluations and workload adjustments were performed. Inspiratory load was adjusted on a weekly basis to maintain 30% of the subject's PImax. Training sessions were carried out at home for both groups and supervised once a week at the hospital.
  • Behavioral: Inpiratory muscle training placebo
    Inspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load.
  • Experimental: Inspiratory muscle training
    Intervention: Behavioral: Inspiratory muscle training
  • Placebo Comparator: Placebo
    Intervention: Behavioral: Inpiratory muscle training placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00815178
Inspiratory training diabetes
No
Hospital de Clínicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Not Provided
Hospital de Clinicas de Porto Alegre
December 2008

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