Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes

August 11, 2017 updated by: Hospital de Clinicas de Porto Alegre

Effect of Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes:Randomized Clinical Trial

In diabetic individuals, changes in ventilatory muscle strength and lung function have been demonstrated over the years. The onset and progression of chronic complications in diabetes should be avoided by reaching glycated hemoglobin (HbA1c) levels below 7%. The control of glycemia through the measurement of HbA1c is fundamental to avoid complications. The inspiratory muscle training has been used in several clinical situations, and may be an alternative for individuals with type 2 diabetes mellitus who have difficulties performing conventional exercises. The long-term effect of inspiratory muscle training on glycemic control has not been tested yet. The aim of this study is to evaluate the effects of inspiratory muscle training on glycemic control in individuals with type 2 diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

An acute high intensity inspiratory muscle exercise session was able to reduce glycemic levels (24%) similarly to an aerobic exercise session (25%) in subjects with type 2 diabetes, demonstrating that this type of exercise inspiratory muscle may have great potential in improving glycemic control.The present study will investigate if training of the inspiratory musculature for 8 and 12 weeks is capable of improving glycated hemoglobin, glucose and inspiratory muscle strength in individuals with type 2 diabetes. In addition, this study will evaluate the effect of inspiratory muscle training, with moderate loading of 30% of the MIP, on volumes and capacities lung in patients with type 2 diabetes. The subjects with type 2 diabetes will be recruited from the ambulatory of the Hospital de Clinicas de Porto Alegre and through newspaper advertisements.

Patients will be submitted to a general evaluation, including clinical history, physical examination, laboratory evaluation and application of the international physical activity questionnaire. Subsequently, individuals will perform assessments of lung functions (lung function assessment, ventilatory muscle strength test, inspiratory muscle strength test) and autonomic assessment (Ewing's tests). Patients will be randomized to perform inspiratory muscle training with a placebo load (MIP 2%) or with moderate intensity (MIP 30%). Upon the randomization, participants will initiate inspiratory musculature training. The exams of HbA1c, glucose and ventilatory muscle strength tests will be performed in three moments: 1) at the initial assessment, 2) in the eighth week of inspiratory muscle training, and 3) at the end of the training (twelfth) week. During inspiratory muscle training, individuals will attend on Hospital de Clinicas de Porto Alegre, once a week, to the supervision of the way the exercise is being performed. Furthermore, it will be set to load on the PowerBreathe ® device for the following week.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio grande do sul
      • Porto Alegre, Rio grande do sul, Brazil, 90.035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes;
  • 30 years and older;
  • HbA1c from 7,5 to 10%.

Exclusion Criteria:

  • Pregnant women;
  • Pulmonary disease (chronic obstructive pulmonary disease, exercise-induced asthma, idiopathic pulmonary fibrosis, sarcoidosis and lung neoplasms);
  • Neuromuscular disease;
  • Body mass index > 35 kg/m²;
  • Individuals who perform physical exercise more than twice a week;
  • Current smoking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inspiratory muscle training
Patients will perform the inspiratory muscle training using a load moderate of 30% of maximal inspiratory pressure (MIP 30%).
Device: Inspiratory muscle training.
Patients will perform the inspiratory muscle training using a moderate load of 30% of maximal inspiratory pressure (MIP 30%). The training will be conducted at home in a period of 30 minutes, 7 times a week, during 12 weeks. During inspiratory muscle training, individuals will attend Hospital de Clinicas de Porto Alegre once a week to the supervision of the way the exercise is being performed. Furthermore, load in the device (powerbreathe) will be adjusted for the individual to use next week.
Placebo Comparator: Placebo inspiratory muscle
Patients will perform the inspiratory muscle training using a load of 2% of maximal inspiratory pressure (MIP 2%).
Device: Placebo inspiratory muscle
Patients will perform the inspiratory muscle training using a very low load of 2% of maximal inspiratory pressure (MIP 2%). The training will be conducted at home in a period of 30 minutes, 7 times a week, in the course of 12 weeks. During inspiratory muscle training, individuals will attend Hospital de Clinicas de Porto Alegre once a week to the supervision of the way the exercise is being performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin in 8 weeks
Time Frame: Evaluated in 8 weeks of inspiratory muscle training
Glycated hemoglobin concentration after 8 weeks of inspiratory muscle training
Evaluated in 8 weeks of inspiratory muscle training
Glycated hemoglobin in 12 weeks
Time Frame: Evaluated in 12 weeks of inspiratory muscle training
Glycated hemoglobin concentration after 12 weeks of inspiratory muscle training
Evaluated in 12 weeks of inspiratory muscle training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose in 8 weeks
Time Frame: Evaluated in 8 weeks of inspiratory muscle training
Fasting plasma glucose concentration after 8 weeks of inspiratory muscle training.
Evaluated in 8 weeks of inspiratory muscle training
Glucose in 12 weeks
Time Frame: Evaluated in 12 weeks of inspiratory muscle training
Fasting plasma glucose concentration after 12 weeks of inspiratory muscle training.
Evaluated in 12 weeks of inspiratory muscle training
Respiratory muscle strength in 8 weeks
Time Frame: Evaluated in 8 weeks of inspiratory muscle training
Maximum respiratory muscle strength after 8 weeks of inspiratory muscle training, through the measurement of the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Evaluated in 8 weeks of inspiratory muscle training
Respiratory muscle strength in 12 weeks
Time Frame: Evaluated in 12 weeks of inspiratory muscle training
Maximum respiratory muscle strength after 12 weeks of inspiratory muscle training, through the measurement of the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP).
Evaluated in 12 weeks of inspiratory muscle training
Ventilatory muscle resistance
Time Frame: Evaluated in 12 weeks of inspiratory muscle training
Muscular endurance ventilatory after 12 weeks of inspiratory muscle training, through analysis of the MIP.
Evaluated in 12 weeks of inspiratory muscle training
Lung functions
Time Frame: Evaluated in 12 weeks of inspiratory muscle training
Capacity and volumes lung after 12 weeks of inspiratory muscle training.
Evaluated in 12 weeks of inspiratory muscle training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Beatriz D'Agord Schaan, PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

January 31, 2019

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61986916.9.0000.5327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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