Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness - Full Text View

Sponsors and Collaborators:	Hospital de Clinicas de Porto Alegre Coordenação de aperfeiçoamento do pessoal de nível superior (CAPES)
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00815178

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

Genetics Home Reference related topics: adenosine monophosphate deaminase deficiency

MedlinePlus related topics: Diabetes Diabetes Complications

Drug Information available for: Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness: A Randomized, Controlled Clinical Trial

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
Inspiratory muscle training: Experimental	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: Placebo Comparator	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

Assigned Interventions

Inspiratory muscle training: Experimental

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: Placebo Comparator

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

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

Locations

Brazil, Rio Grande do Sul
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 do pessoal de nível superior (CAPES)

More Information

Publications:

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.

Responsible Party:	Hospital de Clínicas de Porto Alegre
Study ID Numbers:	Inspiratory training diabetes
Study First Received:	December 26, 2008
Last Updated:	December 26, 2008
ClinicalTrials.gov Identifier:	NCT00815178
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

Study placed in the following topic categories:

Metabolic Diseases
Asthenia
Benzocaine
Diabetes Mellitus
Endocrine System Diseases
Muscle Weakness
Signs and Symptoms
Muscular Diseases

Musculoskeletal Diseases
Diabetes Mellitus, Type 2
Neurologic Manifestations
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Diabetes Complications

Additional relevant MeSH terms:

Neuromuscular Manifestations
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009