Cognitive Impairment Clinical Trial
— my-AHAOfficial title:
Evaluation of an ICT-based Platform for Early Detection and Intervention to Prevent Frailty in Older Adults
Verified date | November 2023 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter, multicultural, randomized control trial. Participants will be recruited from 10 centers located in Italy, Germany, Austria, Spain, United Kingdom, Belgium, Sweden, Japan, South Korea and Australia. The main objective of the study is to examine the efficacy of a sensor-based platform (my-AHA platform) to assess frailty risks and to deliver tailored interventions in order to prevent in elderly subjects conversion from a pre-frail status to a frailty status.
Status | Completed |
Enrollment | 201 |
Est. completion date | December 31, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | INCLUSION CRITERIA for pre-screening 1. Age: over 60 yrs 2. Able to stand and walk unassisted 3. Free of significant cognitive impairment (age-corrected Mini Mental State Examination Test = 24) 4. Free of clinically significant mood disturbance (HADS-Anxiety <15; HADS-depression < 15) 5. Free of any acute or unstable medical conditions 6. Able to understand directions and participate in the protocol 7. Able to sign informed consent Subjects will be enrolled in the study if they meet one or two of the Fried et al. (2001) criteria for Frailty (Pre-Frailty status). 1. Shrinking, evidenced by weight loss (unintentional) = 4.5 kg unintentional in prior 12 months; or at follow-up assessment = 5% of body weight in prior 12 months. 2, Weakness. Grip strength in lowest 20% at baseline adjusted for gender and BMI. 3. Poor endurance and energy. Self-report of exhaustion as indicated by responses to 2 questions on Center for Epidemiologic Studies Depression (CES-D) scale. 4. Slowness .Time to walk 15ft (4.57m) = slowest 20% adjusted for gender and standing height. 5. Low physical activity level. Lowest quintile (25%) by gender for weighted kcal expenditure per week at baseline. EXCLUSION CRITERIA Participant excluded if meets 1 or more of below: Mobility problems 1. cannot stand and ambulate unassisted 2. painful arthritis, spinal stenosis, amputation, or painful foot lesions that limits balance and mobility, Concurrent chronic disease independently contributing to frailty 1. suffers from a significant neurodegenerative disorder, e.g. 1. Alzheimer's disease 2. Lewy body dementia 3. Frontotemporal Lobar Degeneration, Fronto-Temporal Dementia 4. Parkinson's disease 5. multiple sclerosis 6. progressive supranuclear palsy 7. amyotrophic lateral sclerosis 8. hydrocephalus 9. Huntington's disease 10. prion diseases 2. affected by severe peripheral nervous system and/or neuromuscular disorders, e.g. 1. chronic inflammatory demyelinating polyneuropathy 2. myasthenia gravis 3. multiple sclerosis 4. polymyositis Concomitant injury or disease known 1. clinical evidence or history of stroke (within 2 yrs) to impact independently cognitive, 2. clinical evidence or history of transient ischemic attack (within 6 months) psychological or physical function 3. significant head injury with associated loss of consciousness, skull fracture or persisting cognitive impairment (2 years) 4. epilepsy (a single prior seizure is considered acceptable) 5. if meet Diagnostic and Statistical Manual 5 (DSM-5) criteria for: 1. major depressive disorder (current) 2. schizophrenia or other psychotic disorders (lifetime) 3. bipolar disorder (within the past 5 years 4. substance (including alcohol) related disorders (within the past 2 years) Presence of cognitive, sensory or 1. have language deficits that impair testing perceptual deficits that interfere with assessment tasks 2. have significant visual impairment 3. have a significant hearing loss Presence of other conditions or diseases that will compromise ability to undertake interventions (especially physical) 1. have clinically significant cardiovascular disease, i.e: 1. hospitalization for acute coronary syndrome (acute myocardial infarction or unstable, angina) 2. symptoms consistent with angina pectoris, within the 12 months 3. signs or symptoms of clinical heart failure within the 12 months 4. evidence of uncontrolled atrial fibrillation 5. a cardiac pacemaker 2. preexisting or current signs or symptoms of respiratory failure, e.g. 1. chronic obstructive pulmonary disease 2. bronchial asthma 3. lung fibrosis 4. other respiratory disease 3. untreated hypertension 4. metastatic cancer or immunosuppressive therapy 5. concurrent acute or chronic clinically significant immunologic, hepatic (such as presence of encephalopathy or ascites), or endocrine disease (not adequately treated). Unacceptable Test/Laboratory Values 1. Postural hypotension (fall in systolic blood pressure of greater than 30 mmHg or fall in diastolic blood pressure of greater than 20 mmHg on standing compared to sitting) at the time of screening. Subjects who present at the time of screening with postural hypotension yet have no known history of postural hypotension, nor underlying medical condition related to hypotension, may be rescreened |
Country | Name | City | State |
---|---|---|---|
Italy | Aging Brain and Memory Clinic, Department of Neuroscience, University of Torino | Torino |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Choi J, Ahn A, Kim S, Won CW. Global Prevalence of Physical Frailty by Fried's Criteria in Community-Dwelling Elderly With National Population-Based Surveys. J Am Med Dir Assoc. 2015 Jul 1;16(7):548-50. doi: 10.1016/j.jamda.2015.02.004. Epub 2015 Mar 14. — View Citation
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. — View Citation
Kojima G, Taniguchi Y, Iliffe S, Walters K. Frailty as a Predictor of Alzheimer Disease, Vascular Dementia, and All Dementia Among Community-Dwelling Older People: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Oct 1;17(10):881-8. doi: 10.1016/j.jamda.2016.05.013. Epub 2016 Jun 17. — View Citation
Panza F, Solfrizzi V, Frisardi V, Maggi S, Sancarlo D, Adante F, D'Onofrio G, Seripa D, Pilotto A. Different models of frailty in predementia and dementia syndromes. J Nutr Health Aging. 2011 Aug;15(8):711-9. doi: 10.1007/s12603-011-0126-1. — View Citation
Shamliyan T, Talley KM, Ramakrishnan R, Kane RL. Association of frailty with survival: a systematic literature review. Ageing Res Rev. 2013 Mar;12(2):719-36. doi: 10.1016/j.arr.2012.03.001. Epub 2012 Mar 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conversion rate from a pre-frail status to a frail status (Fried criteria) | Comparison of conversion rate in cases and controls between pre-frail status fo frail status | 18 months |
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