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

Primary Purpose

Diabetes Mellitus, Type 2, Rehabilitation, Respiratory Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cardiovascular Rehabilitation
Initial and Final assessment
Sponsored by
União Educacional do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 Diabetes Mellitus, Heart Rate Variability, Rehabilitation, Hemoglobin Glycated

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • União Educacional do NorteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control Group

Interventional Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change from baseline of Heart rate variability at 3 months
With a specific heart rate monitor, Heart Rate Variability (also called RR variability) is the measure of heart rate variation between each pair of heart beats at a given time interval. The results of the heart rate variability analysis are divided into two groups: time domain results and frequency domain results. They are numbers related to the "rhythm" in which the variations occur: VLF - Very Low Frequency: power contained in the range below 0.04Hz. LF - Low Frequency: power contained in the range of 0.04 to 0.15Hz. HF - High Frequency: power contained in the range of 0.15 to 0.4Hz. LF / HF: Ratio between LF and HF powers.
Change from baseline of Glycated Hemoglobin at 3 months
The HbA1c test counts the number of red blood cells that are glycated, that is, linked to a glucose molecule.

Secondary Outcome Measures

Change from baseline of pulse oximetry at every intervention session
With the use of pulse oximetry we will observe the percentage of oxygen that the blood is carrying, compared to the maximum of its transport capacity. Ideally, more than 89% of your red cells should be carrying oxygen.
Change from baseline of subjective sensation of respiratory discomfort at every intervention session
Used on the modified borg scale cr 410 that goes with a score of 0 to 10 where the patient will identify their degree of discomfort after the protocol in which it was submitted;
Change from baseline of Blood Pressure at every intervention session
The expression blood pressure (BP) or blood pressure refers to the pressure exerted by the blood against the wall of the arteries. Blood pressure as well as that of the whole circulatory system is usually slightly above atmospheric pressure, the pressure difference being responsible for keeping the arteries and other vessels not collapsed. In a healthy person, the amount of pressure can vary continuously, depending on the stress, the emotion or if you are doing physical activity.
Change from baseline of the distance traveled at 3 months.
This will be measured in meters during a six-minute walk test in a 30-meter runner where the participant should walk as mush as he/she can in six minutes.

Full Information

First Posted
February 25, 2017
Last Updated
March 22, 2017
Sponsor
União Educacional do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03094767
Brief Title
Cardiorespiratory Parameters and Glycated Hemoglobin of Patients With Type 2 Diabetes After a Rehabilitation Program
Official Title
Cardiorespiratory Parameters and Glycated Hemoglobin of Patients With Type 2 Diabetes After a Rehabilitation Program
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
União Educacional do Norte

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Rehabilitation, Respiratory Therapy
Keywords
Type 2 Diabetes Mellitus, Heart Rate Variability, Rehabilitation, Hemoglobin Glycated

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Interventional Group
Arm Type
Experimental
Arm Description
Patients will participate in the cardiovascular rehabilitation program during 12 weeks.
Intervention Type
Other
Intervention Name(s)
Cardiovascular Rehabilitation
Intervention Description
Aerobic and anaerobic exercises performed for 12 weeks, 3x/week, of 60 minutes each.
Intervention Type
Other
Intervention Name(s)
Initial and Final assessment
Intervention Description
Measuring blood preassure, heart rate, Borg scale, respiratory rate, oxygen saturation and HbA1C in the first day of assessment and after 12 weeks.
Primary Outcome Measure Information:
Title
Change from baseline of Heart rate variability at 3 months
Description
With a specific heart rate monitor, Heart Rate Variability (also called RR variability) is the measure of heart rate variation between each pair of heart beats at a given time interval. The results of the heart rate variability analysis are divided into two groups: time domain results and frequency domain results. They are numbers related to the "rhythm" in which the variations occur: VLF - Very Low Frequency: power contained in the range below 0.04Hz. LF - Low Frequency: power contained in the range of 0.04 to 0.15Hz. HF - High Frequency: power contained in the range of 0.15 to 0.4Hz. LF / HF: Ratio between LF and HF powers.
Time Frame
three months
Title
Change from baseline of Glycated Hemoglobin at 3 months
Description
The HbA1c test counts the number of red blood cells that are glycated, that is, linked to a glucose molecule.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Change from baseline of pulse oximetry at every intervention session
Description
With the use of pulse oximetry we will observe the percentage of oxygen that the blood is carrying, compared to the maximum of its transport capacity. Ideally, more than 89% of your red cells should be carrying oxygen.
Time Frame
three months
Title
Change from baseline of subjective sensation of respiratory discomfort at every intervention session
Description
Used on the modified borg scale cr 410 that goes with a score of 0 to 10 where the patient will identify their degree of discomfort after the protocol in which it was submitted;
Time Frame
three months
Title
Change from baseline of Blood Pressure at every intervention session
Description
The expression blood pressure (BP) or blood pressure refers to the pressure exerted by the blood against the wall of the arteries. Blood pressure as well as that of the whole circulatory system is usually slightly above atmospheric pressure, the pressure difference being responsible for keeping the arteries and other vessels not collapsed. In a healthy person, the amount of pressure can vary continuously, depending on the stress, the emotion or if you are doing physical activity.
Time Frame
three months
Title
Change from baseline of the distance traveled at 3 months.
Description
This will be measured in meters during a six-minute walk test in a 30-meter runner where the participant should walk as mush as he/she can in six minutes.
Time Frame
three months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia da Silva Freitas Marques, Master
Phone
015 55 68 999726363
Email
nataliafreitas2@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo Daminello Raimundo, Doctor
Phone
015 55 11 996957579
Email
rodaminello@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia da Silva Freitas Marques, Master
Organizational Affiliation
União Educacional do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
União Educacional do Norte
City
Rio Branco
State/Province
Acre
ZIP/Postal Code
69915-497
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natália da Silva Freitas Marques, Master
Phone
015 55 68 999726363
Email
nataliafreitas2@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29465549
Citation
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.
Results Reference
derived

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

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