Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-27
Brief Title:
Intensive Aerobic and Resistance Exercise Program IAREP
Sponsor:
National University of Singapore
Organization:
National University of Singapore
Study Overview
Official Title:
Metabolic Inflammatory Cognitive Risk Stratification and Intensive Aerobic and Resistance Exercise Intervention for Middle-aged and Older Adults With Type 2 Diabetes Mellitus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
A 12-weeks Intensive Aerobic and Resistance Exercise Program IAREP intervention will be implemented on high-risk and low-risk of cognitive impairment subjects in type 2 Diabetes Mellitus The study aim to evaluate the effectiveness of IAREP on cognition metabolic health physical health and psychological health in Type 2 Diabetes Mellitus population
Detailed Description:
Purpose A single-site non-randomized prospective clinical trial is proposed to determine the significance of an Intensive Aerobic and Resistance Exercise Program on cognitive function metabolic health and inflammatory conditions in individuals with Type 2 diabetes mellitus T2DM who present with high-risk and low-risk cognitive impairment
Background and Significance T2DM is a leading cause of morbidity and mortality among adults worldwide with approximately 5 million diabetes-related deaths accounting for 128 of all-cause mortality in 2015 The prevalence of T2DM in Asia is on the rise with an anticipated increase from 78 million in 2015 to 140 million by 2040 Asia therefore is emerging as the diabetes epicenter due to rapid economic development urbanization and nutrition transition T2DM is a complex disease with environmental and genetic contributions that cause many severe complications in middle-aged and older adults including a higher susceptibility to mild cognitive impairment MCI and dementia The prevalence of cognitive impairment in T2DM ranges from 218 to 675 worldwide in all adults Our previous study developed a risk stratification score RSS to quickly screen the T2DM population for high-risk or low-risk cognitive impairment Exercise intervention plays an important role in T2DM management Aerobic exercise has multiple benefits to metabolic functions including increasing cardiovascular fitness improving skeletal muscle capillary density and reducing body fat Resistance training is considered a promising intervention for reversing the loss of muscle function and deterioration of muscle structure associated with aging Intervention strategies such as the proposed combined aerobic and resistance training program will provide a guideline to prescribe exercise dosage for individuals with T2DM who are at risk of cognitive impairment
Methods Research Plan The study will recruit 80 subjects who will be assigned to either the exercise intervention group or the non-exercise control group according to their availability The intervention group will receive a 12-week Intensive Aerobic and Resistance Exercise Program IAREP while the control group will not have IAREP exercise and will continue to receive usual care from Jurong National University Polyclinics The primary outcomes include cognition metabolic health inflammatory conditions and physical and psychological health
Background and Significance T2DM is a leading cause of morbidity and mortality among adults worldwide with approximately 5 million diabetes-related deaths accounting for 128 of all-cause mortality in 2015 The prevalence of T2DM in Asia is on the rise with an anticipated increase from 78 million in 2015 to 140 million by 2040 Asia therefore is emerging as the diabetes epicenter due to rapid economic development urbanization and nutrition transition T2DM is a complex disease with environmental and genetic contributions that cause many severe complications in middle-aged and older adults including a higher susceptibility to mild cognitive impairment MCI and dementia The prevalence of cognitive impairment in T2DM ranges from 218 to 675 worldwide in all adults Our previous study developed a risk stratification score RSS to quickly screen the T2DM population for high-risk or low-risk cognitive impairment Exercise intervention plays an important role in T2DM management Aerobic exercise has multiple benefits to metabolic functions including increasing cardiovascular fitness improving skeletal muscle capillary density and reducing body fat Resistance training is considered a promising intervention for reversing the loss of muscle function and deterioration of muscle structure associated with aging Intervention strategies such as the proposed combined aerobic and resistance training program will provide a guideline to prescribe exercise dosage for individuals with T2DM who are at risk of cognitive impairment
Methods Research Plan The study will recruit 80 subjects who will be assigned to either the exercise intervention group or the non-exercise control group according to their availability The intervention group will receive a 12-week Intensive Aerobic and Resistance Exercise Program IAREP while the control group will not have IAREP exercise and will continue to receive usual care from Jurong National University Polyclinics The primary outcomes include cognition metabolic health inflammatory conditions and physical and psychological health
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