Table 3.
My-AHA RCT inclusion and exclusion criteria for participant screening
| Inclusion criteria | |
| 1. Age: over 60 yrs | |
| 2. Familiar with use of smartphones and/or tablet computers | |
| 3. Meet criteria for physical prefrailty (Table 1) | |
| 4. Ambulatory—able to stand and walk unassisted (Table 4) | |
| 5. Free of significant cognitive impairment (Table 2) | |
| 6. Free of clinically significant mood disturbance (Table 2) | |
| 7. Free of any acute or unstable medical conditions (Table 4) | |
| 8. Able to understand directions and participate in the protocol | |
| 9. Able to sign informed consent | |
| Exclusion criteria | Participant excluded if meets 1 or more of below: |
| Mobility problems | 1. Unable 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 CNS disorder (e.g., dementia, Parkinson's disease, multiple sclerosis, progressive supranuclear palsy, amyotrophic lateral sclerosis, hydrocephalus, Huntington's disease, and prion diseases) |
| 2. Affected by severe peripheral nervous system and/or neuromuscular disorders, e.g., CIDP, myasthenia gravis, multiple sclerosis, and polymyositis | |
| Concomitant injury or disease known to impact independently cognitive, psychological, or physical function | 1. Clinical evidence or history of stroke (within 2 yrs) |
| 2. Clinical evidence or history of transient ischemic attack (within 6 months) | |
| 3. Significant head injury with loss of consciousness, skull fracture or persisting cognitive impairment (2 years) | |
| 4. Epilepsy (a single prior seizure is considered acceptable) | |
| 5. If meets DSM-5 criteria for the following: major depressive disorder (current), schizophrenia or other psychotic disorders (lifetime), bipolar disorder (within the past 5 years), and substance (including alcohol)-related disorders (within the past 2 years) | |
| Presence of deficits that interfere with assessment validity | 1. Have language deficits that impair testing |
| 2. Have significant visual impairment | |
| 3. Have a significant hearing loss | |
| Presence of other conditions or diseases that will compromise participants ability to undertake interventions (especially physical) | 1. Have clinically significant cardiovascular disease (e.g., 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). |
| 2. Preexisting or current signs or symptoms of respiratory failure (e.g., chronic obstructive pulmonary disease, bronchial asthma, lung fibrosis, and 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 mm Hg or fall in diastolic blood pressure of greater than 20 mm Hg on standing compared to sitting) at the time of screening. Participants 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 |
Abbreviations: My-AHA, My Active and Healthy Aging; RCT, randomized controlled trial; CNS, central nervous system; CIDP, chronic inflammatory demyelinating polyneuropathy; DSM5, Diagnostic and Statistical Manual of Mental Disorders 5th edition.