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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00815178
Enrollment
25
Registered
2008-12-29
Start date
2006-09-30
Completion date
2008-09-30
Last updated
2008-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Complications, Inspiratory Muscle Weakness

Keywords

inspiratory muscle weakness, autonomic modulation, diabetes mellitus, heart rate variability, functional capacity

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.

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

BEHAVIORALInspiratory 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.

BEHAVIORALInpiratory muscle training placebo

Inspiratory muscle training was carried out on the same basis as in the intervention group but with no inspiratory load.

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Maximum inspiratory pressure8 weeks

Secondary

MeasureTime frame
Peak exercise oxigen consumption8 weeks
pulmonary function8 weeks
autonomic modulation assessed by heart rate variability8 weeks

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026