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

NCT ID: NCT00815178

Last Updated: 2008-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-09-30

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.

Conditions

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Diabetes Complications Inspiratory Muscle Weakness

Keywords

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inspiratory muscle weakness autonomic modulation diabetes mellitus heart rate variability functional capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Inspiratory muscle training

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type BEHAVIORAL

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.

Placebo

Group Type PLACEBO_COMPARATOR

Inpiratory muscle training placebo

Intervention Type BEHAVIORAL

Inspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load.

Interventions

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Inspiratory muscle training

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

Inpiratory muscle training placebo

Inspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Hospital de Clínicas de Porto Alegre

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 18436118 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21200342 (View on PubMed)

Other Identifiers

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Inspiratory training diabetes

Identifier Type: -

Identifier Source: org_study_id