ENGAGE for Brain Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-11-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Motoric Cognitive Risk Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

No one is blinded during this study.

Study Groups

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Physical Activity Intervention (PA)

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

Group Type ACTIVE_COMPARATOR

Physical Activity (PA) Intervention

Intervention Type OTHER

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.

Health Education Intervention (HE)

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.

Group Type PLACEBO_COMPARATOR

Healthy Aging Education (HE) Intervention

Intervention Type OTHER

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.

Interventions

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Physical Activity (PA) Intervention

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.

Intervention Type OTHER

Healthy Aging Education (HE) Intervention

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes