Skip to main content
OpenTrials
Completed

NCT Number: NCT00815178

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Complications Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Inspiratory Muscle Weakness Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

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.

Inpiratory muscle training placebo

Behavioral

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

Primary outcomes

  1. Maximum inspiratory pressure

    Time frame: 8 weeks

Secondary outcomes

  1. Peak exercise oxigen consumption

    Time frame: 8 weeks

  2. pulmonary function

    Time frame: 8 weeks

  3. autonomic modulation assessed by heart rate variability

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 29, 2008
Registry last updated
Dec 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.