ENGAGE for Brain Health (ENGAGE-B)

Tufts University

Status: Completed

Conditions: Motoric Cognitive Risk Syndrome

Treatments: Other: Healthy Aging Education (HE) Intervention; Other: Physical Activity (PA) Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03750682

13136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 60 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 2 patient groups, including a placebo group

Physical Activity Intervention (PA)

Active Comparator group

Description:

The PA intervention will consist of a twice per week group-based moderate-intensity program that includes aerobic, strength, flexibility, and balance training.

Treatment:

Other: Physical Activity (PA) Intervention

Health Education Intervention (HE)

Placebo Comparator group

Description:

The HE intervention will consist of bimonthly lifestyle counseling workshops in a group setting. Participants will receive information on a variety of topics including relevance to older adults, including nutrition, understanding the health care system, dietary guidelines for older adults, safe travel, age-appropriate preventive services, information on resources, etc.

Treatment:

Other: Healthy Aging Education (HE) Intervention