Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03917576
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2019-04-07
Brief Title:
Heart Rate During Exercise in Type 2 Diabetes
Sponsor:
Universidad de Los Lagos
Organization:
Universidad de Los Lagos
Study Overview
Official Title:
Heart Rate Changes in Response to an Exercise Test and to a High Intensity Interval Training Session in Subjects With Normoglycaemic Prediabetes and Type 2 Diabetes Mellitus State
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HRinT2DM
Brief Summary:
Exercise training is a cornerstone for the prevention and treatment of metabolic disorders and associated cardiometabolic complications such as type 2 diabetes mellitus T2D and hypertension Similar to the beneficial health effects after performing conventional continuous exercise modalities high intensity interval training HIIT has been reported as an effective alternative exercise-modality to improve glucose homeostasis in both prediabetes subjects and individuals with T2D diagnosed In this regard although multiple HIIT-based interventions commonly report acute and long term benefits on body composition cardiorespiratory fitness and insulin sensitivity in metabolically compromised subjects little is known about the acute cardiovascular response ie at heart rate level during HIIT in subjects with different glucose control
HIIT is described as performing brief periods of exercise at vigorous or maximal intensity interspersed with inactive or low intensity recovery phases of variable duration In order to characterize different HIIT-based protocols exercise intensity is usually defined as relative percentages of individual maximal cardiorespiratory fitness VO2max or relative maximal power output values Nevertheless the need for specific technological equipment to assess these parameters usually limit the prescription and recommendations of HIIT in clinical settings and other public health contexts at massive level Additionally the use of self-perceived exertion scales and heart rate HR variations upon HIIT have been demonstrating to be accessible and feasible strategies to regulate exercise intensity during HIIT For example it was reported that HR and self-perceived exertion scores increased progressively in T2D subjects parallel to the oxygen consumption rate throughout an acute HIIT session performed on cycle ergometer Consequently it is conceivable to hypothesize that determining HR variations during HIIT might optimize the recommendation of this training methodology in metabolically compromised subjects as those at risk or with T2D diagnosed Therefore the aim of the present study was To describe and compare the acute heart rate changes in response to an incremental maximal exercise test and a single HIIT session between normoglycaemic NG prediabetes Pre-T2D and type 2 diabetes mellitus T2D subjects
HIIT is described as performing brief periods of exercise at vigorous or maximal intensity interspersed with inactive or low intensity recovery phases of variable duration In order to characterize different HIIT-based protocols exercise intensity is usually defined as relative percentages of individual maximal cardiorespiratory fitness VO2max or relative maximal power output values Nevertheless the need for specific technological equipment to assess these parameters usually limit the prescription and recommendations of HIIT in clinical settings and other public health contexts at massive level Additionally the use of self-perceived exertion scales and heart rate HR variations upon HIIT have been demonstrating to be accessible and feasible strategies to regulate exercise intensity during HIIT For example it was reported that HR and self-perceived exertion scores increased progressively in T2D subjects parallel to the oxygen consumption rate throughout an acute HIIT session performed on cycle ergometer Consequently it is conceivable to hypothesize that determining HR variations during HIIT might optimize the recommendation of this training methodology in metabolically compromised subjects as those at risk or with T2D diagnosed Therefore the aim of the present study was To describe and compare the acute heart rate changes in response to an incremental maximal exercise test and a single HIIT session between normoglycaemic NG prediabetes Pre-T2D and type 2 diabetes mellitus T2D subjects
Detailed Description:
This cross-sectional study will use a non-probabilistic sample of 75 adult subjects characterized as healthy normoglycaemic and others with disturbed glucose homeostasis subjects all referred by a physician to the exercise programme of our research centre The present study will be carried out in accordance with the Declaration of Helsinki and was approved by the Scientific Ethics Committee of the Universidad de La Frontera All volunteers read and signed an informed consent The inclusion criteria will be a aged 18-60 y b previously screened by physician professional c diagnosed with normoglycaemic prediabetes or T2D state d and living in Temuco city The exclusion criteria will be a low maximal cardiorespiratory fitness defined as VO2max 21 mlkg-1min-1 below the expected value for the subjects sex and age 11 b not receiving pharmacologic hypotensive treatment with β-blockers and c having no musculoskeletal limitations to perform exercise cycling The total sample size will be divided in three groups according to the standard glycaemic classification 12 normoglycaemic NG n 32 pre-diabetes Pre-T2D n 30 and type 2 diabetes T2D n 13 The study considered three stages of measurements enrollment exercise test single HIIT session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None