Motoric Cognitive Risk Syndrome Clinical Trial
— ENGAGE-BOfficial title:
ENhancing Independence Using Group-Based Community Interventions for Healthy AGing Elders: The ENGAGE for Brain Health Pilot Study
NCT number | NCT03750682 |
Other study ID # | 13136 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | November 27, 2020 |
Verified date | February 2022 |
Source | Tufts University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | November 27, 2020 |
Est. primary completion date | March 13, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 89 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Jean Mayer Human Nutrition Research Center on Aging at Tufts University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts University | Boston Older Americans Independence Center, Somerville Council on Aging, Massachusetts |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Wimo A, Guerchet M, Ali GC, Wu YT, Prina AM, Winblad B, Jönsson 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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. | 6 Months | |
Secondary | 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. | 6 Months | |
Secondary | 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. | 6 Months | |
Secondary | 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. | 6 Months | |
Secondary | 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. | 6 Months | |
Secondary | 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. | 6 Months | |
Secondary | 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. | 6 Months | |
Secondary | Fall History | Participants will be asked about any recent falls they have experienced at each assessment visit. | 6 Months |
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