Skip to main content

Table 1 Exclusion criteria for the Seniors Health and Activity Research Program Pilot Trial.

From: Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P) Study, a randomized controlled trial

Exclusion Criteria Related to Physical Activity

   Telephone Screening Visits

â—¦ Severe rheumatologic or orthopedic diseases

â—¦ Severe pulmonary disease

â—¦ Actively participating in a formal exercise program within the past month (defined as >30 min/week)

â—¦ Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest which required resuscitation, use of a cardiac defibrillator, or uncontrolled angina

â—¦ Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention

â—¦ Receiving physical therapy for gait, balance, or other lower extremity training

â—¦ Myocardial infarction, Coronary Artery Bypass Graft, or valve replacement within past six months

â—¦ Serious conduction disorder (e.g. 3rd degree heart block), uncontrolled arrhythmia

â—¦ Pulmonary embolism or deep venous thrombosis within past 6 months

â—¦ Hip fracture, hip or knee replacement, or spinal surgery within past 4 months

â—¦ Severe hypertension

   Clinic Visits

â—¦ None

Exclusion Criteria Related to Cognition

   Telephone Screening Visits

â—¦ Neurologic disease, e.g. Alzheimer's disease (or other types of dementia), stroke that required hospitalization, Parkinson's, multiple sclerosis, Amyotrophic Lateral Sclerosis, or Mild Cognitive Impairment

◦ Telephone Interview for Cognitive Status (TICS) ≤ 31

â—¦ Current use of cognitive enhancing prescription or investigational medications

â—¦ History of participation in a cognitive training program in the last two years

   Clinic Visits

◦ 3MSE score <88 (<80 for ≤8 years education)

◦ Scores ≥2 standard deviations below normal on memory or non-memory domain tests (speed of processing and verbal fluency)

â—¦ Other significant factors that may affect the ability for cognitive training, including a history of head trauma resulting in a loss of consciousness, current use of benzodiazepines, hypnotic or anticholinergic agents

â—¦ Stroke within past 4 months

◦ Baseline Geriatric Depression Scale score ≥8

Exclusion Criteria Related to Trial Design or Adherence

   Telephone Screening Visits

â—¦ Age <70 or >85 years

â—¦ Unwillingness to be randomized to any of the four intervention conditions

â—¦ Failure to provide the name of a personal physician

â—¦ Living in a nursing home

â—¦ Terminal illness with life expectancy less than 8 months

â—¦ Unable to communicate because of severe hearing loss or speech disorder

â—¦ Severe visual impairment

â—¦ Excessive alcohol use (>14 drinks per week)

â—¦ Member of household is already enrolled

â—¦ Lives distant from the study site or is planning to move out of the area in the next year or leave the area for more than one month during the next year

â—¦ Other temporary intervening events, such as sick spouse, bereavement, or recent move

â—¦ Participation in another intervention trial

   Clinic Visits

â—¦ Inability to commit to intervention schedule requirements

â—¦ Failure to provide informed consent