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

Primary Purpose

Diabetes Complications, Inspiratory Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle training
Inpiratory muscle training placebo
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Complications focused on measuring inspiratory muscle weakness, autonomic modulation, diabetes mellitus, heart rate variability, functional capacity

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inspiratory muscle training

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Maximum inspiratory pressure

Secondary Outcome Measures

Peak exercise oxigen consumption
pulmonary function
autonomic modulation assessed by heart rate variability

Full Information

First Posted
December 26, 2008
Last Updated
December 26, 2008
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT00815178
Brief Title
Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness
Official Title
Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness: A Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications, Inspiratory Muscle Weakness
Keywords
inspiratory muscle weakness, autonomic modulation, diabetes mellitus, heart rate variability, functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Inspiratory muscle training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Inpiratory muscle training placebo
Intervention Description
Inspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load.
Primary Outcome Measure Information:
Title
Maximum inspiratory pressure
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Peak exercise oxigen consumption
Time Frame
8 weeks
Title
pulmonary function
Time Frame
8 weeks
Title
autonomic modulation assessed by heart rate variability
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
18436118
Citation
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. doi: 10.1016/j.jacc.2007.12.045.
Results Reference
background
PubMed Identifier
21200342
Citation
Correa AP, Ribeiro JP, Balzan FM, Mundstock L, Ferlin EL, Moraes RS. Inspiratory muscle training in type 2 diabetes with inspiratory muscle weakness. Med Sci Sports Exerc. 2011 Jul;43(7):1135-41. doi: 10.1249/MSS.0b013e31820a7c12.
Results Reference
derived

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

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