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

March 22, 2017 updated by: NATÁLIA DA SILVA FREITAS MARQUES, União Educacional do Norte

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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;

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Acre
      • Rio Branco, Acre, Brazil, 69915-497
        • Recruiting
        • União Educacional do Norte
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
EXPERIMENTAL: Interventional Group
Patients will participate in the cardiovascular rehabilitation program during 12 weeks.
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.
Other: Cardiovascular Rehabilitation
Aerobic and anaerobic exercises performed for 12 weeks, 3x/week, of 60 minutes each.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Heart rate variability at 3 months
Time Frame: three 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.
three months
Change from baseline of Glycated Hemoglobin at 3 months
Time Frame: three months
The HbA1c test counts the number of red blood cells that are glycated, that is, linked to a glucose molecule.
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of pulse oximetry at every intervention session
Time Frame: three months
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.
three months
Change from baseline of subjective sensation of respiratory discomfort at every intervention session
Time Frame: three months
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;
three months
Change from baseline of Blood Pressure at every intervention session
Time Frame: three months
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.
three months
Change from baseline of the distance traveled at 3 months.
Time Frame: three 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.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

União Educacional do Norte

Investigators

  • Principal Investigator: Natalia da Silva Freitas Marques, Master, União Educacional do Norte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

November 1, 2017

Study Registration Dates

First Submitted

February 25, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (ACTUAL)

March 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.616.721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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