Cardiorespiratory Parameters and Glycated Hemoglobin of Patients With Type 2 Diabetes After a Rehabilitation Program

NCT ID: NCT03094767

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-11-30

Brief Summary

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Cardiovascular autonomic dysfunction reflects the pathophysiology of Diabetes Mellitus in this patient group favors an increase in morbidity and mortality related to cardiovascular events, and for this reason has been one of the most studied clinical entities.

Therefore this work aims to analyze the cardiorespiratory parameters and glycated hemoglobin after the commission of a rehabilitation program in patients with diabetes mellitus type 2.

The collection protocol is to check the heart rate, blood pressure, double product, Borg scale, variability heart rate and glycated hemoglobin of patients with type 2 diabetes This project this is an experimental study, the type randomized clinical trial on the hemodynamic response and glucose levels in patients with DM2 institutionalized in Acre Hospital Foundation submitted to one rehabilitation program consisting of aerobic and anaerobic exercises performed for 12 weeks in three weekly meetings, of 60 minutes each.

Detailed Description

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Background: Built with evidence that makes it possible to work in cardiac rehabilitation programs in patients with type 2 diabetes with more security, guaranteeing them an improvement in cardiorespiratory fitness, the hemodynamic and glycemic variables, allowing them a better quality of life

Method/Design: The research instrument is applied before and after the practice of the proposed exercise program (consisting of aerobic and anaerobic exercises performed for 12 weeks in three weekly meetings, of 60 minutes each). The instrument is based on the following collection protocol: assessment of BP, HR, Borg scale, respiratory rate (RR), oxygen saturation (SAT), the DP calculation and will be carried out the examination to check HbA1C Will be performed for 12 weeks in three weekly meetings, of 60minutes each, in total of 36 sessions with antecipated 60 pacients splited in 2 groups "Control" and "intervention"

Discussion: Correlate the variability of heart rate behavior and glycated hemoglobin after the exercise program; To demonstrate the possible association between the change of the cardiorespiratory parameters according to the variation of glycated hemoglobin; Demonstrate the possibility of association between the variation of the cardiorespiratory parameters and glycated hemoglobin according to sex;

Conditions

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Diabetes Mellitus, Type 2 Rehabilitation Respiratory Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Patients will be submitted only to the initial protocol of rehabilitation, i. e., they will have only one session on the initial day and one session on the final day, after 12 weeks.

Group Type EXPERIMENTAL

Initial and Final assessment

Intervention Type OTHER

Measuring blood preassure, heart rate, Borg scale, respiratory rate, oxygen saturation and HbA1C in the first day of assessment and after 12 weeks.

Interventional Group

Patients will participate in the cardiovascular rehabilitation program during 12 weeks.

Group Type EXPERIMENTAL

Cardiovascular Rehabilitation

Intervention Type OTHER

Aerobic and anaerobic exercises performed for 12 weeks, 3x/week, of 60 minutes each.

Initial and Final assessment

Intervention Type OTHER

Measuring blood preassure, heart rate, Borg scale, respiratory rate, oxygen saturation and HbA1C in the first day of assessment and after 12 weeks.

Interventions

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Cardiovascular Rehabilitation

Aerobic and anaerobic exercises performed for 12 weeks, 3x/week, of 60 minutes each.

Intervention Type OTHER

Initial and Final assessment

Measuring blood preassure, heart rate, Borg scale, respiratory rate, oxygen saturation and HbA1C in the first day of assessment and after 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* type 2 Diabetes
* Sedentary
* Non-smoker
* with medical prescription for rehabilitation program.

Exclusion Criteria

* Neurological disease
* Acute heart failure
* Morbid obesity
* Atrial fibrillation
* Sick sinus syndrome
* Atrioventricular block grade II or III
* Who used beta-blockers
* Who used antiarrhythmic medication.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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União Educacional do Norte

OTHER

Sponsor Role lead

Responsible Party

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NATÁLIA DA SILVA FREITAS MARQUES

Principal Investigator, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natalia da Silva Freitas Marques, Master

Role: PRINCIPAL_INVESTIGATOR

União Educacional do Norte

Locations

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União Educacional do Norte

Rio Branco, Acre, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Natalia da Silva Freitas Marques, Master

Role: CONTACT

015 55 68 999726363

Rodrigo Daminello Raimundo, Doctor

Role: CONTACT

015 55 11 996957579

Facility Contacts

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Natália da Silva Freitas Marques, Master

Role: primary

015 55 68 999726363

References

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Marques NDSF, Abreu LC, Santos BVD, Neto CFR, Silva JRCD, Braga KKS, Uchoa KDS, Moraes LMS, Ferreira LCP, Ribeiro NG, Santos SLD, Silva TAD, Andrade PE, Raimundo RD. Cardiorespiratory parameters and glycated hemoglobin of patients with type 2 diabetes after a rehabilitation program. Medicine (Baltimore). 2018 Feb;97(8):e9321. doi: 10.1097/MD.0000000000009321.

Reference Type DERIVED
PMID: 29465549 (View on PubMed)

Other Identifiers

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1.616.721

Identifier Type: -

Identifier Source: org_study_id

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