NCT00752440

Brief Summary

This study describes a controlled randomized clinical trial to evaluate the effect of inspiratory muscle training in patients with diabetic autonomic neuropathy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_4 diabetes-mellitus

Timeline
Completed

Started Aug 2006

Typical duration for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 16, 2008

Status Verified

September 1, 2008

Enrollment Period

2.3 years

First QC Date

September 12, 2008

Last Update Submit

September 15, 2008

Conditions

Diabetes MellitusDiabetic Autonomic Neuropathy

Keywords

Diabetes MellitusAutonomic NeuropathyInspiratory Muscle training

Outcome Measures

Primary Outcomes (1)

  • Inspiratory muscle strength

    eight

Secondary Outcomes (1)

  • Variability of heart rate

    eight

Interventions

Inspiratory muscle training (IMT)OTHER

IMT (30 min 7 times per week, for 8 weeks)

Also known as: Diabetic autonomic neuropathy;, Inspiratory muscle function testing;, forced vital capacity and forced expiratory volume;, Maximal functional capacity with incremental exercise test;, variability of the heart frequency.

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic autonomic neuropathy
  • Age between 36 and
  • years old and signed in informed consent form

You may not qualify if:

  • Presence of congestive heart failure
  • Chronic obstructive pulmonary disease (FEV1 \< 70% and/or FEV1%\< 80
  • Class II or III obesity (body mass index \> 35)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institudo de Cardiologia do Rio Grande do Sul

Porto Alegre, RGS, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusDiabetic Neuropathies

Interventions

Vital CapacityForced Expiratory Volume

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

Total Lung CapacityLung Volume MeasurementsRespiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaPulmonary Ventilation

Study Officials

  • Beatriz D Schann, MD, ScD

    Institudo de cardiologia de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz D Schaan, MD, ScD

CONTACT

555132303600beatrizschann@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 15, 2008

Study Start

August 1, 2006

Primary Completion

November 1, 2008

Study Completion

July 1, 2009

Last Updated

September 16, 2008

Record last verified: 2008-09

Locations

BR(1)