Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes
Effect of Inspiratory Muscle Training on Glycemic Control in Individuals With Type 2 Diabetes:Randomized Clinical Trial
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedStudy Start
First participant enrolled
July 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedAugust 14, 2017
August 1, 2017
1.5 years
June 15, 2017
August 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Glycated hemoglobin in 8 weeks
Glycated hemoglobin concentration after 8 weeks of inspiratory muscle training
Evaluated in 8 weeks of inspiratory muscle training
Glycated hemoglobin in 12 weeks
Glycated hemoglobin concentration after 12 weeks of inspiratory muscle training
Evaluated in 12 weeks of inspiratory muscle training
Secondary Outcomes (6)
Glucose in 8 weeks
Evaluated in 8 weeks of inspiratory muscle training
Glucose in 12 weeks
Evaluated in 12 weeks of inspiratory muscle training
Respiratory muscle strength in 8 weeks
Evaluated in 8 weeks of inspiratory muscle training
Respiratory muscle strength in 12 weeks
Evaluated in 12 weeks of inspiratory muscle training
Ventilatory muscle resistance
Evaluated in 12 weeks of inspiratory muscle training
- +1 more secondary outcomes
Study Arms (2)
Inspiratory muscle training
EXPERIMENTALPatients will perform the inspiratory muscle training using a load moderate of 30% of maximal inspiratory pressure (MIP 30%).
Placebo inspiratory muscle
PLACEBO COMPARATORPatients will perform the inspiratory muscle training using a load of 2% of maximal inspiratory pressure (MIP 2%).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes;
- years and older;
- HbA1c from 7,5 to 10%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil
Related Publications (1)
Pinto MB, Bock PM, Schein ASO, Portes J, Monteiro RB, Schaan BD. Inspiratory Muscle Training on Glucose Control in Diabetes: A Randomized Clinical Trial. Int J Sport Nutr Exerc Metab. 2021 Jan 1;31(1):21-31. doi: 10.1123/ijsnem.2020-0175. Epub 2020 Nov 27.
PMID: 33248438DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beatriz D'Agord Schaan, PhD
Hospital de Clinicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2017
First Posted
June 19, 2017
Study Start
July 11, 2017
Primary Completion
December 31, 2018
Study Completion
January 31, 2019
Last Updated
August 14, 2017
Record last verified: 2017-08