Effects of Inspiratory Muscle Training on Type 2 Diabetes Mellitus Patients With Inspiratory Muscle Weakness
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 26, 2008
CompletedFirst Posted
Study publicly available on registry
December 29, 2008
CompletedDecember 29, 2008
December 1, 2008
2 years
December 26, 2008
December 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum inspiratory pressure
8 weeks
Secondary Outcomes (3)
Peak exercise oxigen consumption
8 weeks
pulmonary function
8 weeks
autonomic modulation assessed by heart rate variability
8 weeks
Study Arms (2)
Inspiratory muscle training
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Inspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load.
Eligibility Criteria
You may qualify if:
- diabetes melittus
- sedentary
- inspiratory muscle weakness with PImax \< 70% of the predicted
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Related Publications (2)
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.
PMID: 18436118BACKGROUNDCorrea AP, Ribeiro JP, Balzan FM, Mundstock L, Ferlin EL, Moraes RS. Inspiratory muscle training in type 2 diabetes with inspiratory muscle weakness. Med Sci Sports Exerc. 2011 Jul;43(7):1135-41. doi: 10.1249/MSS.0b013e31820a7c12.
PMID: 21200342DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 26, 2008
First Posted
December 29, 2008
Study Start
September 1, 2006
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 29, 2008
Record last verified: 2008-12