Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146036
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-11-13
Brief Title:
Effects of Different Exercise Snacking Modalities on Glycemic Control in Patients With Type 2 Diabetes
Sponsor:
University of Nis
Organization:
University of Nis
Study Overview
Official Title:
A Comparison of the Acute Effects of Two Exercise Snacking Modalities on Glycemic Control in Overweight Patients With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
Patients with type 2 diabetes T2DM face an increased risk of obesity hypertension and hyperglycemia attributed to impaired cardiorespiratory fitness elevated Hb1AC levels and impaired lipid status Therefore effective prevention of complications and T2DM-related diseases is crucial for increasing the life expectancy of T2DM patients Regular exercise plays a crucial role in the prevention and management of diabetes and its associated complications However most T2DM patients are not engaged in exercise The most common causes are a lack of time monotonous training patterns and the severe exhaustion patients experience after recently developed and effective HIIT and SIT programs Therefore recent studies have explored the concept of exercise snacking brief isolated bouts 1 min of intense exercise spread throughout the day
as a promising strategy to improve glycemic control functional capacity and cardiometabolic health among clinical and healthy populations However the type intensity and volume of exercise bouts that result in the best improvement are unknown Therefore we hypothesize that these exercise modalities may also acutely improve glycaemic control in sedentary overweight patients with T2DM
1 This study will examine the acute impact of two modalities of Exercise Snacking compared with a no-exercise control CON on glycemic control and blood pressure
2 Compare the acute effects of two Exercise Snacking modalities
3 Collect data on individuals perceptions of each workout mode using measures of Rate of Perceived Exertion RPE enjoyment affect and adverse events
as a promising strategy to improve glycemic control functional capacity and cardiometabolic health among clinical and healthy populations However the type intensity and volume of exercise bouts that result in the best improvement are unknown Therefore we hypothesize that these exercise modalities may also acutely improve glycaemic control in sedentary overweight patients with T2DM
1 This study will examine the acute impact of two modalities of Exercise Snacking compared with a no-exercise control CON on glycemic control and blood pressure
2 Compare the acute effects of two Exercise Snacking modalities
3 Collect data on individuals perceptions of each workout mode using measures of Rate of Perceived Exertion RPE enjoyment affect and adverse events
Detailed Description:
A randomized crossover design will be used for the acute effects study
Prior to the experimental protocols participants will be asked to come to the lab on four separate days which will be scheduled to meet individual schedules
Day one An electrocardiography stress test ECG test will be performed to assess if participants could enroll in the study The test will be conducted monitored and reviewed by a Cardiologist and written approval will be necessary for further inclusion in the study Moreover during the first visit a continuous glucose monitoring iCGM device - will be inserted on the participants non-dominant upper arm according to the manual guidelines The accuracy of the iCGM devices will be validated using capillary vs interstitial iCGM measurements
Day two The participants will be tested for anthropometric characteristics height and body composition This procedure is necessary to determine the BMI most validly All tests will be conducted in the laboratory of the Faculty of Sports and Physical Education
Day three The maximal incremental test on the cycle ergometer will be used to determine the cardiorespiratory fitness level VO2max VO2peak as well as the resting heart rate HRrest maximum HR HRmax and HR recovery HRRTEST These parameters primarily HRmax will be crucial when implementing the intensity of the session which will not be done in an all effort manner Participants will be familiarized with wearing the heart rate monitors and using the rating of perceived exertion scale RPE too Briefly after a 5-minute warm-up at 50 W the intensity will be increased by 15 Wmin until the tempo can no longer be maintained at 50 rpm Cardiorespiratory fitness will be measured using an online gas analysis system Cosmed Quark CPET Rome Italy VO2peak will be determined as the highest ten-breath rolling average and accepted if two or more of the following criteria were met 1 voluntary exhaustion 2 a plateau in VO2 despite increasing intensity 3 maximal heart rate within 10 beats of the age-predicted maximum This protocol already has been used in patients with T2DM
Day four On the fourth day the familiarization process will be conducted Briefly participants will be given the opportunity to try on the exercise sessions that we will use in the main protocols
Main experimental protocols Before each trial participants will be asked to avoid any strenuous exercise at least for 72 hours After 7 days of baseline assessment participants will come to the laboratory Each of these trials will be separated by at least 5-7 days Before and after each protocol blood glucose levels SBP and DPB will be measured as well as RPE enjoyment affect and adverse events using the standardized questionaries and rating scales Moreover HR will be measured continuously during each exercise session
1 Participants will come to the laboratory three times a day and the protocols will not last longer than half an hour Therefore after a short-term warm-up on the cycle ergometer 5 minutes the intensity was determined by the participants themselves short-term intense bouts of cycling 6x1 minute at 90 HR max with a minute of active break between bouts will be performed at 50 W Recovery will last 3 minutes also at the self-paced The whole process will be repeated two more times during the day with intervals of 1-4 hours
2 For the SS group training will consist of three separate sprints on the cycle ergometer separated by 1-4 h The SS exercise bouts will consist of a 2-minute warm-up followed by a 20-s sprint and then a 1-minute cooldown three separate workout sessions each lasting 3 min 20 s The warm-up cooldown and recovery periods will all be performed at 50 W Each sprint will be performed at a resistance of 021 N mkg and include a 10-s period when participants will be advised to accelerate the number of rpm as fast as possible
3 Control - During CON participants will come to the lab and remain sedentary throughout this entire period
Prior to the experimental protocols participants will be asked to come to the lab on four separate days which will be scheduled to meet individual schedules
Day one An electrocardiography stress test ECG test will be performed to assess if participants could enroll in the study The test will be conducted monitored and reviewed by a Cardiologist and written approval will be necessary for further inclusion in the study Moreover during the first visit a continuous glucose monitoring iCGM device - will be inserted on the participants non-dominant upper arm according to the manual guidelines The accuracy of the iCGM devices will be validated using capillary vs interstitial iCGM measurements
Day two The participants will be tested for anthropometric characteristics height and body composition This procedure is necessary to determine the BMI most validly All tests will be conducted in the laboratory of the Faculty of Sports and Physical Education
Day three The maximal incremental test on the cycle ergometer will be used to determine the cardiorespiratory fitness level VO2max VO2peak as well as the resting heart rate HRrest maximum HR HRmax and HR recovery HRRTEST These parameters primarily HRmax will be crucial when implementing the intensity of the session which will not be done in an all effort manner Participants will be familiarized with wearing the heart rate monitors and using the rating of perceived exertion scale RPE too Briefly after a 5-minute warm-up at 50 W the intensity will be increased by 15 Wmin until the tempo can no longer be maintained at 50 rpm Cardiorespiratory fitness will be measured using an online gas analysis system Cosmed Quark CPET Rome Italy VO2peak will be determined as the highest ten-breath rolling average and accepted if two or more of the following criteria were met 1 voluntary exhaustion 2 a plateau in VO2 despite increasing intensity 3 maximal heart rate within 10 beats of the age-predicted maximum This protocol already has been used in patients with T2DM
Day four On the fourth day the familiarization process will be conducted Briefly participants will be given the opportunity to try on the exercise sessions that we will use in the main protocols
Main experimental protocols Before each trial participants will be asked to avoid any strenuous exercise at least for 72 hours After 7 days of baseline assessment participants will come to the laboratory Each of these trials will be separated by at least 5-7 days Before and after each protocol blood glucose levels SBP and DPB will be measured as well as RPE enjoyment affect and adverse events using the standardized questionaries and rating scales Moreover HR will be measured continuously during each exercise session
1 Participants will come to the laboratory three times a day and the protocols will not last longer than half an hour Therefore after a short-term warm-up on the cycle ergometer 5 minutes the intensity was determined by the participants themselves short-term intense bouts of cycling 6x1 minute at 90 HR max with a minute of active break between bouts will be performed at 50 W Recovery will last 3 minutes also at the self-paced The whole process will be repeated two more times during the day with intervals of 1-4 hours
2 For the SS group training will consist of three separate sprints on the cycle ergometer separated by 1-4 h The SS exercise bouts will consist of a 2-minute warm-up followed by a 20-s sprint and then a 1-minute cooldown three separate workout sessions each lasting 3 min 20 s The warm-up cooldown and recovery periods will all be performed at 50 W Each sprint will be performed at a resistance of 021 N mkg and include a 10-s period when participants will be advised to accelerate the number of rpm as fast as possible
3 Control - During CON participants will come to the lab and remain sedentary throughout this entire period
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