ENGAGE for Brain Health

NCT03750682 | Completed

• 1 other identifier: 13136
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Motoric Cognitive Risk Syndrome

Outcome Measures

Primary Outcomes (2)

• Measuring the safety of a 6 month PA or HE intervention in a community setting in older adults with MCR

  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.

  6 Months

• Measuring the success (feasibility) of integrating clinical exercise programs into real-world community-based settings.

  Feasibility will be measured by adherence to PA by percent attendance. Successful adherence will be defined by an attendance rate of \>60%.

  6 Months

Secondary Outcomes (8)

• fNIRS (Functional Near-Infrared Spectroscopy) assessment and submaximal cycle ergometry

  6 Months

• Accelerometry

  6 Months

• 6-Minute Walk Test (6MWT)

  6 Months

• Grip Strength Test

  6 Months

• Complex Walking Tasks (CWT's)

  6 Months

Study Arms (2)

Physical Activity Intervention (PA)

ACTIVE COMPARATOR

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

Other: Physical Activity (PA) Intervention

Health Education Intervention (HE)

PLACEBO COMPARATOR

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.

Other: Healthy Aging Education (HE) Intervention

Interventions

Physical Activity (PA) Intervention 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.

Physical Activity Intervention (PA)

Healthy Aging Education (HE) Intervention 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.

Health Education Intervention (HE)

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• Boston Older Americans Independence Center: collaborator
• Somerville Council on Aging, Massachusetts: collaborator

Study Sites (1)

Jean Mayer Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (9)

• 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.

  PMID: 30010808 BACKGROUND

• 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.

  PMID: 27583652 BACKGROUND

• 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.

  PMID: 29255839 BACKGROUND

• Gates N, Fiatarone Singh MA, Sachdev PS, Valenzuela M. The effect of exercise training on cognitive function in older adults with mild cognitive impairment: a meta-analysis of randomized controlled trials. Am J Geriatr Psychiatry. 2013 Nov;21(11):1086-97. doi: 10.1016/j.jagp.2013.02.018. Epub 2013 Jul 3.

  PMID: 23831175 BACKGROUND

• 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.

  PMID: 26248559 BACKGROUND

• 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.

  PMID: 22987797 BACKGROUND

• 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.

  PMID: 23886735 BACKGROUND

• 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.

  PMID: 24866862 BACKGROUND

• Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.

  PMID: 7183759 BACKGROUND

MeSH Terms

Interventions

Exercise; Methods; Helium

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• Kieran Reid, PhD, MPH

  Jean Mayer Human Nutrition Research Center on Aging at Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No one is blinded during this study.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist II

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 23, 2018
• Study Start: January 1, 2019
• Primary Completion: March 13, 2020
• Study Completion: November 27, 2020
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)