Ignite Creation Date:
2024-05-06 @ 7:31 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02541838
Status:
TERMINATED
Last Update Posted:
2022-01-31
First Post:
2015-09-01
Brief Title:
Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
High Intensity Muscle Power and Balance Perturbation Training to Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DPN
Brief Summary:
Type 2 diabetes results in a host of neuromuscular muscular and autonomic system impairments that accelerate age-associated limitations in functional independence and the risk of falls Diabetic peripheral neuropathy DPN contributes to functional declines in balance and mobility because of limitations metabolic abnormalities The constellation of impairments accompanying type 2 diabetes diminishes muscle function and performance including strength and power Loss of strength at higher speeds of movement deficit in power occurs in neural activation of muscles changes in muscle properties and through in older individuals with DPN compared to older controls Consequently this deficit in speed dependent muscle power production leads to limitations in rapidly responding to sudden loss of balance stability to prevent falling The goal of this pilot research program is to determine the feasibility and effectiveness of a mechanism-based therapeutic intervention fro improving balance and mobility functions and preventing falls in older adults with DPN The investigators pan to use the results from this pilot study to design and implement a larger randomized control trial
Detailed Description:
The long-term goal of this research is to establish the effectiveness of a mechanism-based therapeutic intervention for improving balance and mobility functions and preventing falls in older adults with type 2 diabetic peripheral neuropathy DPN
Specific Aim 1 will determine if combined high intensity isolated leg muscle power exercise with balance perturbation training ActiveStep and aerobic exercise achieves greater improvements in balance stabilization protective stepping behavior and kinematics and mobility function gait parameters and timed functional measures than a lifestyle based intervention that primarily focuses on aerobic exercise through underlying mechanisms of improved neuromuscular activation rate and magnitude and sensorimotor control improved muscle quality and increased blood flow to enhance neuromuscular and sensorimotor performance in people with DPN
Specific Aim 2 To determine if a neuromotor balance training program combined with muscle power exercise training and aerobic exercise leading to improved neuromuscular and sensorimotor mechanisms is more effective in improving clinical tests of balance and mobility functions in those with DPN compared with a traditional exercise intervention
Specific Aim 1 will determine if combined high intensity isolated leg muscle power exercise with balance perturbation training ActiveStep and aerobic exercise achieves greater improvements in balance stabilization protective stepping behavior and kinematics and mobility function gait parameters and timed functional measures than a lifestyle based intervention that primarily focuses on aerobic exercise through underlying mechanisms of improved neuromuscular activation rate and magnitude and sensorimotor control improved muscle quality and increased blood flow to enhance neuromuscular and sensorimotor performance in people with DPN
Specific Aim 2 To determine if a neuromotor balance training program combined with muscle power exercise training and aerobic exercise leading to improved neuromuscular and sensorimotor mechanisms is more effective in improving clinical tests of balance and mobility functions in those with DPN compared with a traditional exercise intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None