ENGAGE for Brain Health
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 60 - 89 |
| Updated: | 11/24/2018 |
| Start Date: | January 1, 2019 |
| End Date: | November 1, 2019 |
| Contact: | Kieran Reid, PhD, MPH |
| Email: | kieran.reid@tufts.edu |
| Phone: | 617-556-3081 |
ENhancing Independence Using Group-Based Community Interventions for Healthy AGing Elders: The ENGAGE for Brain Health Pilot Study
Age-related cognitive decline has a profound impact on the daily functioning of older adults,
their families and healthcare systems. Despite its significant personal, societal and
economic impact, no pharmacologic therapies presently exist to mitigate age-related cognitive
decline. As the population of older adults continues to rapidly increase, the implementation
of effective and scalable low-cost interventions that may maintain the cognitive independence
of broad populations of older persons are now of urgent public health priority.
their families and healthcare systems. Despite its significant personal, societal and
economic impact, no pharmacologic therapies presently exist to mitigate age-related cognitive
decline. As the population of older adults continues to rapidly increase, the implementation
of effective and scalable low-cost interventions that may maintain the cognitive independence
of broad populations of older persons are now of urgent public health priority.
ENGAGE-B is a single blind, parallel-group, community-based randomized controlled pilot
study. The overall objective of the study is to build on our recently completed ENGAGE pilot
study and further examine and characterize the feasibility and effectiveness of translating
the LIFE study physical activity intervention (PA) into a real-world community-based senior
center setting. ENGAGE-B will target the recruitment of older adults with subjective memory
complaints and slow gait (motoric cognitive risk syndrome (MCR)). Participants with MCR will
be randomized to a 24-week PA intervention (n = 20) or to a healthy aging education control
intervention (HE) (n = 20). ENGAGE-B will also test a highly practical and scalable
innovation for the delivery of exercise programming for at-risk older adults in the community
setting. An existing community-based senior center employee ("Community Health Promoter"),
without a formal background in exercise physiology, will be trained by the study
investigators to deliver the PA intervention among older adults with MCR. The primary
feasibility outcomes will be assessed by quantifying intervention adherence and the
occurrence of adverse events across the PA and HE intervention arms. Secondary and
exploratory outcomes will include the comparative evaluation of specific domains of cognitive
performance (executive function, global cognition, working memory, computerized cognitive
testing and complex walking tasks), non-invasive functional near-infrared spectroscopy
(fNIRS) derived measures of prefrontal brain activation, mobility, acclerometry-derived
estimates of physical activity, depression, quality of life and costs associated with
delivering the respective interventions. Results from this proposed pilot study are intended
as the basis for a larger and more definitive pragmatic trial in older adults. If successful
this pilot work will serve as an exciting preliminary model to potentially target and
mitigate the loss of cognitive independence across a variety of community-based locations.
study. The overall objective of the study is to build on our recently completed ENGAGE pilot
study and further examine and characterize the feasibility and effectiveness of translating
the LIFE study physical activity intervention (PA) into a real-world community-based senior
center setting. ENGAGE-B will target the recruitment of older adults with subjective memory
complaints and slow gait (motoric cognitive risk syndrome (MCR)). Participants with MCR will
be randomized to a 24-week PA intervention (n = 20) or to a healthy aging education control
intervention (HE) (n = 20). ENGAGE-B will also test a highly practical and scalable
innovation for the delivery of exercise programming for at-risk older adults in the community
setting. An existing community-based senior center employee ("Community Health Promoter"),
without a formal background in exercise physiology, will be trained by the study
investigators to deliver the PA intervention among older adults with MCR. The primary
feasibility outcomes will be assessed by quantifying intervention adherence and the
occurrence of adverse events across the PA and HE intervention arms. Secondary and
exploratory outcomes will include the comparative evaluation of specific domains of cognitive
performance (executive function, global cognition, working memory, computerized cognitive
testing and complex walking tasks), non-invasive functional near-infrared spectroscopy
(fNIRS) derived measures of prefrontal brain activation, mobility, acclerometry-derived
estimates of physical activity, depression, quality of life and costs associated with
delivering the respective interventions. Results from this proposed pilot study are intended
as the basis for a larger and more definitive pragmatic trial in older adults. If successful
this pilot work will serve as an exciting preliminary model to potentially target and
mitigate the loss of cognitive independence across a variety of community-based locations.
Inclusion Criteria:
- • Men and Women age 60-89 years, community-dwelling, ambulatory
- Presence of MCR syndrome
- Sedentary (reporting ≤ 20 min/week of regularly structured physical activity in
the past month)
- Written permission from PCP for study participation
- Willingness to be randomized and participate for 24 weeks
Exclusion Criteria:
- • Acute or terminal illness
- Modified Mini-Mental State Examination Score <80(<76 if African American)*
- Myocardial Infarction in the previous 6 months
- Symptomatic coronary artery disease
- Upper or lower extremity fracture in the previous 6 months
- Resting blood pressure >180/100 mmHg
- Unable to communicate due to severe hearing loss or speech disorder
- Severe visual impairment that may preclude participation in the study assessments
or interventions
- Non-English speaking
We found this trial at
1
site
Boston, Massachusetts 02111
Principal Investigator: Kieran Reid, PhD, MPH
Phone: 617-556-3303
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