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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2008

Detailed Description

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.

Interventions

  • Behavioral: 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Inspiratory muscle training
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Maximum inspiratory pressure
    • Time Frame: 8 weeks

Secondary Measures

  • Peak exercise oxigen consumption
    • Time Frame: 8 weeks
  • pulmonary function
    • Time Frame: 8 weeks
  • autonomic modulation assessed by heart rate variability
    • Time Frame: 8 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital de Clinicas de Porto Alegre
  • Collaborator
    • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Provider of Information About this Clinical Study

References

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.

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