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

União Educacional do Norte

Status: Unknown

Conditions: Rehabilitation; Respiratory Therapy; Diabetes Mellitus, Type 2

Treatments: Other: Cardiovascular Rehabilitation; Other: Initial and Final assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT03094767

1.616.721

Details and patient eligibility

About

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.

Full 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;

Enrollment: 60 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control Group

Experimental group

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.

Treatment:

Other: Initial and Final assessment

Interventional Group

Experimental group

Description:

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

Treatment:

Other: Cardiovascular Rehabilitation

Other: Initial and Final assessment