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Motoric Cognitive Risk SyndromeENGAGE-BNCT03750682

ENGAGE for Brain Health

A study testing Physical Activity (PA) Intervention and Healthy Aging Education (HE) Intervention in people with Motoric Cognitive Risk Syndrome, run by Tufts University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Motoric Cognitive Risk Syndrome
What is being tested?
Physical Activity (PA) Intervention and Healthy Aging Education (HE) Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
1 Jan 2019to 27 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • 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

Who cannot join

  • • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Jean Mayer Human Nutrition Research Center on Aging at Tufts University

    Boston, Massachusetts, 02111

Other trials in United States

About this study

Official title: ENhancing Independence Using Group-Based Community Interventions for Healthy AGing Elders: The ENGAGE for Brain Health Pilot Study

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.

Read the 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.

Being tested
Physical Activity (PA) Intervention, Healthy Aging Education (HE) Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity (PA) InterventionOther

    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.

  • Healthy Aging Education (HE) InterventionOther

    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.

Study groups in NCT03750682
Study groupRoleWhat they receive
Physical Activity Intervention (PA)Active comparatorThe PA intervention will consist of a twice per week group-based moderate-intensity program that includes aerobic, strength, flexibility, and balance training.
Receives: Other: Physical Activity (PA) Intervention
Health Education Intervention (HE)Placebo comparatorThe 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.
Receives: Other: Healthy Aging Education (HE) Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 Months

  2. 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%.

    Measured: 6 Months

Secondary outcomes (8)

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

    We will utilize Functional Near-Infrared Spectroscopy (fNIRS) to non-invasively evaluate the brain hemodynamics of participants during a single bout of moderate intensity submaximal cycling exercise.

    Measured: 6 Months

  2. Accelerometry

    Regular activity level will be measured using accelerometry (GT3X+, Actigraph, Pensacola, FL). The actigraph, attached to an elastic belt, will be worn around the waist of the participant. These accelerometers are small enough to be unobtrusive and produce little interference with normal physical activity. Participants will be instructed to wear the actigraph for a 7-day period during waking hours and remove it for sleep and bathing only. Activity will be recorded using 1-second epochs.

    Measured: 6 Months

  3. 6-Minute Walk Test (6MWT)

    The 6MWT tests functional exercise capacity by measuring the distance a participant can walk within a 6 minute time period. The 6MWT is a beneficial tool in assessing functional exercise capacity in older adults. The 6MWT will be performed in a corridor of the Holland Street Senior Center in Somerville, MA on a 40 meter course. Participants will be instructed to walk as far as they can in six minutes without running or jogging. Cones will be set up at each turnaround point of the course and participants will be instructed to complete as many laps as they can without overexerting themselves. The test will be stopped if any of the following symptoms occur: chest pain, severe dyspnea, muscle cramping, diaphoresis, or any other symptom the investigator deems unsafe. Subjects' walking distance will be recorded.

    Measured: 6 Months

  4. Grip Strength Test

    Hand grip strength will be measured in the dominant hand with a Jamar Handheld Dynamometer (Patterson Medical, Warrenville, IL). The participants will perform the test while sitting comfortably with shoulder adducted and neutrally rotated, the elbow supported on a table and flexed to 90 degrees, forearm and wrist in neutral position. The patients will be instructed to perform a maximal isometric contraction. The test will be repeated after 10 sec. and the highest value will be recorded.

    Measured: 6 Months

  5. Complex Walking Tasks (CWT's)

    During the CWTs, subjects will first be asked to walk on an even surface for 7 meters, as fast as possible while remaining safe. Subjects will be then asked to repeat the walk in their usual pace at the same time as subtracting 3 from 50 and keep subtracting until the 7 meters walk is completed. Subjects' complex walking speed will be timed with a stopwatch and each subtraction will be recorded.

    Measured: 6 Months

  6. Quality of Well Being

    The self-administered version of the Quality of Well-Being Scale will be used to assess general quality of life. This instrument provides a comprehensive measure of health-related quality of life that assesses health symptoms and functioning. This scale has 6 parts. Part 1: acute and chronic symptoms, part 2: self care, part 3: mobility, part 4: physical activity, part 5: usual activity, part 6: general health. There are 79 questions total. Each question is uses the scale: have you... in the past 0 days, 1 day, 2 days, 3 days. There is no scoring or total scoring mechanism. Outcome depends on the question being asked. For example, if a participant reports no hospital visits in the past 3 days that is considered better than reporting no hospital visits in the past 1 day.

    Measured: 6 Months

  7. Falls Efficacy Scale-International

    The Falls Efficacy Scale-International is a questionnaire that evaluates the fear of falling among community dwelling older adults. This questionnaire will be administered at baseline and 24 weeks.

    Measured: 6 Months

  8. Fall History

    Participants will be asked about any recent falls they have experienced at each assessment visit.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2018
  2. Study start1 Jan 2019
  3. Primary completion13 Mar 2020
  4. Study completion27 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
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)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03750682
Sponsor's protocol ID
13136
Acronym
ENGAGE-B
Status last verified
Feb 2022
First submitted
19 Nov 2018
Last updated
14 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30010808

  • 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.

    PubMed 27583652

  • 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.

    PubMed 29255839

  • 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.

    PubMed 23831175

  • 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.

    PubMed 26248559

  • 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.

    PubMed 22987797

  • 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.

    PubMed 23886735

  • 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.

    PubMed 24866862

  • 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.

    PubMed 7183759

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity (PA) Intervention and Healthy Aging Education (HE) Intervention in people with Motoric Cognitive Risk Syndrome, run by Tufts University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring the safety of a 6 month PA or HE intervention in a community setting in older adults with MCR (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03750682, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.

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