Cardiorespiratory Parameters and Glycated Hemoglobin of Patients With Type 2 Diabetes After a Rehabilitation Program
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 25, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedMarch 29, 2017
March 1, 2017
8 months
February 25, 2017
March 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
three months
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.
three months
Secondary Outcomes (4)
Change from baseline of pulse oximetry at every intervention session
three months
Change from baseline of subjective sensation of respiratory discomfort at every intervention session
three months
Change from baseline of Blood Pressure at every intervention session
three months
Change from baseline of the distance traveled at 3 months.
three months
Study Arms (2)
Control Group
EXPERIMENTALPatients 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
EXPERIMENTALPatients will participate in the cardiovascular rehabilitation program during 12 weeks.
Interventions
Aerobic and anaerobic exercises performed for 12 weeks, 3x/week, of 60 minutes each.
Measuring blood preassure, heart rate, Borg scale, respiratory rate, oxygen saturation and HbA1C in the first day of assessment and after 12 weeks.
Eligibility Criteria
You may qualify if:
- type 2 Diabetes
- Sedentary
- Non-smoker
- with medical prescription for rehabilitation program.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
União Educacional do Norte
Rio Branco, Acre, 69915-497, Brazil
Related Publications (1)
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.
PMID: 29465549DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natalia da Silva Freitas Marques, Master
União Educacional do Norte
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Research
Study Record Dates
First Submitted
February 25, 2017
First Posted
March 29, 2017
Study Start
October 1, 2016
Primary Completion
June 1, 2017
Study Completion
November 1, 2017
Last Updated
March 29, 2017
Record last verified: 2017-03