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

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ClinicalTrials.gov Identifier: NCT03191435
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: Inspiratory muscle training. Device: Placebo inspiratory muscle Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Randomized clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes:Randomized Clinical Trial
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.

  6. Lung functions [ Time Frame: Evaluated in 12 weeks of inspiratory muscle training ]
    Capacity and volumes lung after 12 weeks of inspiratory muscle training.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191435


Contacts
Contact: Beatriz D'Agord Schaan, PhD 55 51993138534 bschaan@hcpa.edu.br
Contact: Mariana Brutto de Pinto 55 51 981512270 maribpinto@yahoo.com.br

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio grande do sul, Brazil, 90.035-903
Contact: Beatriz D'agord Schaan, PhD       bschaan@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Beatriz D'Agord Schaan, PhD Hospital de Clinicas de Porto Alegre

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03191435     History of Changes
Other Study ID Numbers: 61986916.9.0000.5327
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
Diabetes mellitus, type 2
Inspiratory muscle training
Glycemic control
Glucose
Exercise
Diaphragm exercise
Inspiratory loading

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Respiratory Aspiration
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes