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

Diabetes Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00815178
• Other study ID #: Inspiratory training diabetes
• Status: Completed
• Phase: N/A
• First received: December 26, 2008
• Last updated: December 26, 2008
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: December 2008
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Inspiratory Muscle Weakness
• Muscle Weakness
• Paresis
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum inspiratory pressure		8 weeks	No
Secondary	Peak exercise oxigen consumption		8 weeks	No
Secondary	pulmonary function		8 weeks	No
Secondary	autonomic modulation assessed by heart rate variability		8 weeks	No