Clinical trial NCT03750682: ENGAGE for Brain Health
Official title: ENhancing Independence Using Group-Based Community Interventions for Healthy AGing Elders: The ENGAGE for Brain Health Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motoric Cognitive Risk Syndrome
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Boston Older Americans Independence Center
name: Somerville Council on Aging, Massachusetts
First posted: 2018-11-23
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The ENGAGE for Brain Health is designed as a single blind, randomized-controlled, parallel group pilot study. This study plans to enroll up to 40 participants to be randomized into the PA or HE intervention group.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measuring the safety of a 6 month PA or HE intervention in a community setting in older adults with MCR
timeFrame: 6 Months
measure: Measuring the success (feasibility) of integrating clinical exercise programs into real-world community-based settings.
timeFrame: 6 Months
Secondary outcomes:
measure: fNIRS (Functional Near-Infrared Spectroscopy) assessment and submaximal cycle ergometry
timeFrame: 6 Months
measure: Accelerometry
timeFrame: 6 Months
measure: 6-Minute Walk Test (6MWT)
timeFrame: 6 Months
measure: Grip Strength Test
timeFrame: 6 Months
measure: Complex Walking Tasks (CWT's)
timeFrame: 6 Months
measure: Quality of Well Being
timeFrame: 6 Months
measure: Falls Efficacy Scale-International
timeFrame: 6 Months
measure: Fall History
timeFrame: 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Jean Mayer Human Nutrition Research Center on Aging at Tufts University
name: Kieran Reid, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reid KF, Laussen J, Bhatia K, Englund DA, Kirn DR, Price LL, Manini TM, Liu CK, Kowaleski C, Fielding RA. Translating the Lifestyle Interventions and Independence for Elders Clinical Trial to Older Adults in a Real-World Community-Based Setting. J Gerontol A Biol Sci Med Sci. 2019 May 16;74(6):924-928. doi: 10.1093/gerona/gly152.
citation: Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jonsson L, Liu Z, Prince M. The worldwide costs of dementia 2015 and comparisons with 2010. Alzheimers Dement. 2017 Jan;13(1):1-7. doi: 10.1016/j.jalz.2016.07.150. Epub 2016 Aug 29.
citation: Brasure M, Desai P, Davila H, Nelson VA, Calvert C, Jutkowitz E, Butler M, Fink HA, Ratner E, Hemmy LS, McCarten JR, Barclay TR, Kane RL. Physical Activity Interventions in Preventing Cognitive Decline and Alzheimer-Type Dementia: A Systematic Review. Ann Intern Med. 2018 Jan 2;168(1):30-38. doi: 10.7326/M17-1528. Epub 2017 Dec 19.
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citation: Allali G, Ayers EI, Verghese J. Motoric Cognitive Risk Syndrome Subtypes and Cognitive Profiles. J Gerontol A Biol Sci Med Sci. 2016 Mar;71(3):378-84. doi: 10.1093/gerona/glv092. Epub 2015 Aug 6.
citation: Verghese J, Wang C, Lipton RB, Holtzer R. Motoric cognitive risk syndrome and the risk of dementia. J Gerontol A Biol Sci Med Sci. 2013 Apr;68(4):412-8. doi: 10.1093/gerona/gls191. Epub 2012 Sep 17.
citation: Rosano C, Chang YF, Kuller LH, Guralnik JM, Studenski SA, Aizenstein HJ, Gianaros PJ, Lopez OL, Longstreth WT Jr, Newman AB. Long-term survival in adults 65 years and older with white matter hyperintensity: association with performance on the digit symbol substitution test. Psychosom Med. 2013 Sep;75(7):624-31. doi: 10.1097/PSY.0b013e31829c1df2. Epub 2013 Jul 25.
citation: Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD; LIFE study investigators. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA. 2014 Jun 18;311(23):2387-96. doi: 10.1001/jama.2014.5616.
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