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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness: A Randomized, Controlled Clinical Trial

Conditions
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Diabetes Complications, Inspiratory Muscle Weakness

Intervention / Treatment
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* Behavioral: Inspiratory muscle training
* Behavioral: Inpiratory muscle training placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory muscle training<br> | Behavioral: Inspiratory muscle training<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Behavioral: Inpiratory muscle training placebo<br>* Inspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum inspiratory pressure |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak exercise oxigen consumption |  | 8 weeks | 
| pulmonary function |  | 8 weeks | 
| autonomic modulation assessed by heart rate variability |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inspiratory muscle weakness, autonomic modulation, diabetes mellitus, heart rate variability, functional capacity