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

This study has been completed.
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00815178
First received: December 26, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Complications
Inspiratory Muscle Weakness
Behavioral: Inspiratory muscle training
Behavioral: Inpiratory muscle training placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness: A Randomized, Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Maximum inspiratory pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak exercise oxigen consumption [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • pulmonary function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • autonomic modulation assessed by heart rate variability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inspiratory muscle training 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.
Placebo Comparator: Placebo 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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815178

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00815178     History of Changes
Other Study ID Numbers: Inspiratory training diabetes
Study First Received: December 26, 2008
Last Updated: December 26, 2008
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital de Clinicas de Porto Alegre:
inspiratory muscle weakness
autonomic modulation
diabetes mellitus
heart rate variability
functional capacity

Additional relevant MeSH terms:
Respiratory Aspiration
Asthenia
Diabetes Mellitus
Diabetes Mellitus, Type 2
Muscle Weakness
Paresis
Diabetes Complications
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on August 19, 2014