Status:
COMPLETED
Investigating My Active and Healthy Aging
Lead Sponsor:
University of Turin, Italy
Conditions:
Frail Elderly Syndrome
Cognitive Impairment
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
In the past decade, frailty has attracted great attention of the scientific community and public health organizations as precursor and contributor of age-related diseases. Frailty is a common clinical...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA for pre-screening
- Age: over 60 yrs
- Able to stand and walk unassisted
- Free of significant cognitive impairment (age-corrected Mini Mental State Examination Test ≥ 24)
- Free of clinically significant mood disturbance (HADS-Anxiety \<15; HADS-depression \< 15)
- Free of any acute or unstable medical conditions
- Able to understand directions and participate in the protocol
- 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
- cannot stand and ambulate unassisted
- painful arthritis, spinal stenosis, amputation, or painful foot lesions that limits balance and mobility,
- Concurrent chronic disease independently contributing to frailty
- suffers from a significant neurodegenerative disorder, e.g.
- Alzheimer's disease
- Lewy body dementia
- Frontotemporal Lobar Degeneration, Fronto-Temporal Dementia
- Parkinson's disease
- multiple sclerosis
- progressive supranuclear palsy
- amyotrophic lateral sclerosis
- hydrocephalus
- Huntington's disease
- prion diseases
- affected by severe peripheral nervous system and/or neuromuscular disorders, e.g.
- chronic inflammatory demyelinating polyneuropathy
- myasthenia gravis
- multiple sclerosis
- polymyositis
- Concomitant injury or disease known
- clinical evidence or history of stroke (within 2 yrs) to impact independently cognitive,
- clinical evidence or history of transient ischemic attack (within 6 months) psychological or physical function
- significant head injury with associated loss of consciousness, skull fracture or persisting cognitive impairment (2 years)
- epilepsy (a single prior seizure is considered acceptable)
- if meet Diagnostic and Statistical Manual 5 (DSM-5) criteria for:
- major depressive disorder (current)
- schizophrenia or other psychotic disorders (lifetime)
- bipolar disorder (within the past 5 years
- substance (including alcohol) related disorders (within the past 2 years)
- Presence of cognitive, sensory or
- have language deficits that impair testing perceptual deficits that interfere with assessment tasks
- have significant visual impairment
- have a significant hearing loss
- Presence of other conditions or diseases that will compromise ability to undertake interventions (especially physical)
- have clinically significant cardiovascular disease, i.e:
- hospitalization for acute coronary syndrome (acute myocardial infarction or unstable, angina)
- symptoms consistent with angina pectoris, within the 12 months
- signs or symptoms of clinical heart failure within the 12 months
- evidence of uncontrolled atrial fibrillation
- a cardiac pacemaker
- preexisting or current signs or symptoms of respiratory failure, e.g.
- chronic obstructive pulmonary disease
- bronchial asthma
- lung fibrosis
- other respiratory disease
- untreated hypertension
- metastatic cancer or immunosuppressive therapy
- 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
Exclusion
Key Trial Info
Start Date :
May 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03342976
Start Date
May 3 2018
End Date
December 31 2020
Last Update
November 30 2023
Active Locations (1)
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1
Aging Brain and Memory Clinic, Department of Neuroscience, University of Torino
Torino, Italy, 10126