ENGAGE for Brain Health
Condition: Motoric Cognitive Risk Syndrome
Study type: Interventional

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.
    

Intervention name(s): Physical Activity (PA) Intervention; Healthy Aging Education (HE) Intervention
Intervention type(s): Other; Other
Intervention description(s): The PA intervention will consist of a twice per week group- based moderate-intensity multimodal program that includes aerobic, strength, flexibility, and balance training, as previously described. The Community Health Promoter will be trained and certified by Dr. Reid to deliver the PA intervention. PA will be conducted at the Holland Street Senior Center in Somerville, MA. The center is equipped with a large dining hall and corridors which will be utilized to perform the various components of the PA intervention for ENGAGE-B. This real-world approach was shown to be safe, feasible and effective in the initial ENGAGE study among older adults with severe mobility-limitations. Throughout PA, walking will be the primary mode of exercise, given its widespread applicabilityThe study staff will administer an Adverse Event/Concomitant Medication Questionnaire biweekly to all PA subjects.; The HE intervention will also be conducted at the Holland Street Senior Center in Somerville, MA. Participants will receive bimonthly lifestyle counseling workshops in a group setting. Participants will receive information on a variety of topics of relevance to older adults (e.g., nutrition for brain health, effective negotiation of the health care system, dietary guidelines for older adults, safe travel, age-appropriate preventive services and screenings, resources for reliable health information, etc.). All intervention materials will be submitted for IRB approval prior to the presentation. In addition to educational offerings, an instructor led program (5-10 minutes) of gentle upper extremity stretching exercises and relaxation techniques are to be performed during each class.
The study staff will administer an Adverse Event/Concomitant Medication Questionnaire biweekly to all HE subjects.
Allocation: Randomized
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Other