Cardiorespiratory Parameters and Glycated Hemoglobin of Patients With Type 2 Diabetes After a Rehabilitation Program
- Conditions
- RehabilitationDiabetes Mellitus, Type 2Respiratory Therapy
- Interventions
- Other: Cardiovascular RehabilitationOther: Initial and Final assessment
- Registration Number
- NCT03094767
- Lead Sponsor
- União Educacional do Norte
- 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;
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- type 2 Diabetes
- Sedentary
- Non-smoker
- with medical prescription for rehabilitation program.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Interventional Group Cardiovascular Rehabilitation Patients will participate in the cardiovascular rehabilitation program during 12 weeks. Control Group Initial and Final assessment 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. Interventional Group Initial and Final assessment Patients will participate in the cardiovascular rehabilitation program during 12 weeks.
- Primary Outcome Measures
Name Time Method Change from baseline of Glycated Hemoglobin at 3 months three months The HbA1c test counts the number of red blood cells that are glycated, that is, linked to a glucose molecule.
Change from baseline of Heart rate variability at 3 months 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.
- Secondary Outcome Measures
Name Time Method Change from baseline of pulse oximetry at every intervention session 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.
Change from baseline of subjective sensation of respiratory discomfort at every intervention session 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;
Change from baseline of Blood Pressure at every intervention session 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.
Change from baseline of the distance traveled at 3 months. 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.
Trial Locations
- Locations (1)
União Educacional do Norte
🇧🇷Rio Branco, Acre, Brazil