ENhancing Independence Using Group-Based Community Interventions for Healthy AGing Elders: The ENGAGE for Brain Health Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tufts University
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Measuring the safety of a 6 month PA or HE intervention in a community setting in older adults with MCR
Study Overview
Brief Summary
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.
Detailed Description
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, accelerometry-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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
No one is blinded during this study.
Eligibility Criteria
- Ages
- 60 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Measuring the safety of a 6 month PA or HE intervention in a community setting in older adults with MCR
Time Frame: 6 Months
Safety will be measured by the number of adverse events and serious adverse events. The investigators will compare the rates of adverse events and serious adverse events between the physical activity and healthy aging education intervention randomized arms.
Measuring the success (feasibility) of integrating clinical exercise programs into real-world community-based settings.
Time Frame: 6 Months
Feasibility will be measured by adherence to PA by percent attendance. Successful adherence will be defined by an attendance rate of \>60%.
Secondary Outcomes
- Grip Strength Test(6 Months)
- Complex Walking Tasks (CWT's)(6 Months)
- fNIRS (Functional Near-Infrared Spectroscopy) assessment and submaximal cycle ergometry(6 Months)
- 6-Minute Walk Test (6MWT)(6 Months)
- Accelerometry(6 Months)
- Quality of Well Being(6 Months)
- Falls Efficacy Scale-International(6 Months)
- Fall History(6 Months)
Investigators
Kieran Reid
Scientist II
Tufts University