Clinical trial NCT03094767: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Rehabilitation
Respiratory Therapy
Keywords: Type 2 Diabetes Mellitus
Heart Rate Variability
Rehabilitation
Hemoglobin Glycated
Lead sponsor: União Educacional do Norte
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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;

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.

Primary outcomes:
measure: Change from baseline of Heart rate variability at 3 months
timeFrame: three months
measure: Change from baseline of Glycated Hemoglobin at 3 months
timeFrame: three months
Secondary outcomes:
measure: Change from baseline of pulse oximetry at every intervention session
timeFrame: three months
measure: Change from baseline of subjective sensation of respiratory discomfort at every intervention session
timeFrame: three months
measure: Change from baseline of Blood Pressure at every intervention session
timeFrame: three months
measure: Change from baseline of the distance traveled at 3 months.
timeFrame: three months
Other outcomes:
Locations:
city: Rio Branco
country: Brazil
facility: União Educacional do Norte
state: Acre
Study officials:
affiliation: União Educacional do Norte
name: Natalia da Silva Freitas Marques, Master
role: PRINCIPAL_INVESTIGATOR
References:
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.