Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness
This study has been completed.
Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborator:
Coordenação de aperfeiçoamento do pessoal de nível superior (CAPES)
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
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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
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 do pessoal de nível superior (CAPES)
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 Signs and Symptoms, Respiratory |
Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013