Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340659
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-08
Brief Title:
Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimers in At-risk Older Adults The Exergames Telerehabilitation Study
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Concurrent Aerobic Exercise and Cognitive Training to Prevent Alzheimers in At-risk Older Adults The Exergames Telerehabilitation Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Significance of Research QuestionPurpose Subjective cognitive decline SCD is regarded as the first clinical manifestation in the AD-dementia continuum and currently has a prevalence of 112 in adults over the age of 45 with incidence increasing with greater age Furthermore population-based studies suggest that between 50 and 80 of older individuals aged 70 years and older who perform normally on cognitive tests report some form of perceived decline in cognitive functioning when asked The SCD state is unique as this population is more likely than their healthy peers to present with AD biomarkers such as neurodegeneration and amyloid burden and therefore represents probable preclinical AD relative to other causes of SCD Likewise growing evidence suggests that a significant proportion of those adults are subsequently found to develop MCI or AD following the classic SCD-MCI-AD trajectory with SCD increasing MCI risk 15-3 fold Preventing Alzheimers disease AD is arguably the most important approach to address the dementia epidemic worldwide because 996 of drug trials failed and no drugs can yet prevent cure or even slow AD A treatment that delays the onset of AD by five years could save 89 billion in 2030This highlights an urgent and pressing need to develop behavioral interventions to prevent AD and slow its progression
This study will use a randomized 2-parallel group trial design that is guided by the Consolidated Standards of Reporting Trials CONSORTand the SPIRIT checklist We will randomize 104 community-dwelling older adults to one of two arms for 3 months home-based asynchronous telerehabilitation Exergame HbExergame or home-based asynchronous telerehabilitation aerobic exercise HbAEx Randomization will allocate subjects on a 11 allocation ratio within each age stratum 65-74 and 75 and will use permuted blocks of 8 and 4 We do not expect equal numbers of subjects in each age stratum but want to balance the groups for each age Investigators will be blinded to group assignment All participants will be blinded to study aims and reminded as needed not to discuss their experiences with outcome assessors Outcome assessors also blinded to group allocations will measure 1 feasibility attendance adherence to exercise dose systems usability scale 2 preliminary cognition fluid cognition primary outcome attention episodic memory and processing speed secondary outcomes using the NIH Toolbox cognition battery and aerobic fitness VO2peak and 6-minute walk distance and 3 blood neurotrophic biomarkers
This study will use a randomized 2-parallel group trial design that is guided by the Consolidated Standards of Reporting Trials CONSORTand the SPIRIT checklist We will randomize 104 community-dwelling older adults to one of two arms for 3 months home-based asynchronous telerehabilitation Exergame HbExergame or home-based asynchronous telerehabilitation aerobic exercise HbAEx Randomization will allocate subjects on a 11 allocation ratio within each age stratum 65-74 and 75 and will use permuted blocks of 8 and 4 We do not expect equal numbers of subjects in each age stratum but want to balance the groups for each age Investigators will be blinded to group assignment All participants will be blinded to study aims and reminded as needed not to discuss their experiences with outcome assessors Outcome assessors also blinded to group allocations will measure 1 feasibility attendance adherence to exercise dose systems usability scale 2 preliminary cognition fluid cognition primary outcome attention episodic memory and processing speed secondary outcomes using the NIH Toolbox cognition battery and aerobic fitness VO2peak and 6-minute walk distance and 3 blood neurotrophic biomarkers
Detailed Description:
None
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