Seniors Health and Activity Research Program-Pilot

Completed · Not applicable

Conditions studied: Cognitive Function

In brief

The purpose of this pilot study is to develop and conduct well-designed trial to assess whether a multi-factorial intervention involving physical activity and cognitive training reduces the risk of significant cognitive decline in older individuals.

Key facts

Study ID

NCT00688155

Run by

Wake Forest University Health Sciences

People needed

73

Starts

2008-05-01

Expected to finish

2010-06-30

Last updated by the study team

2018-01-04

Who can join

Age: 70 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 70 to 85 years
• Summary score between 88 (80 for less than 8 years of education) and 95 on the Modified Mini-Mental Exam
• Sedentary lifestyle, i.e., not actively participating in a formal exercise program within the past 3 months (defined as 30 minutes or more of formal exercise at least once a week; brisk walks will be considered formal exercise, leisurely walks will not)
• Fluency in standard American English (to limit staffing and translation costs in this pilot)
• Willingness to be randomized to any of the four intervention conditions

You may not qualify if…

• Failure to provide the name of a personal physician
• Living in a nursing home; persons living in assisted or independent housing will not be excluded
• Unable to communicate because of severe hearing loss or speech disorder
• Severe visual impairment, which would preclude completion of the assessments and/or intervention
• Neurologic disease, e.g. Alzheimer's (or other types of dementia), stroke that required hospitalization, Parkinson's, multiple sclerosis, amyotrophic lateral sclerosis, or prior diagnosis of mild cognitive impairment (MCI)
• Abnormal functioning based on the modified Telephone Interview for Cognitive Status (less than 30)
• Positive screen for MCI or dementia
• Scores greater than or equal to 1.5 standard deviations below normal on memory and non-memory domain tests (speed of processing, and verbal fluency)
• Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease
• Terminal illness with life expectancy less than 8 months, as determined by a physician
• Severe pulmonary disease, e.g., on home oxygen or chronic steroids
• Severe cardiac disease, including New York Health Association 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
• Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe or acute psychiatric disorder (e.g. bipolar disorder or major depression, schizophrenia), excessive alcohol use (more than 14 drinks per wk); persons with managed depression (on stable dosage for at least 3 months) will not be excluded
• Baseline Geriatric Depression Scale score greater than 6
• 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, and current use of cognitive enhancing prescription or investigational medications (e.g., donepezil, selegiline, tacrine)
• Member of household is already enrolled
• Lives distant from the study site or is planning to move out of the area in next 3 years or leave the area for more than 3 months during the next year
• History of participation in a cognitive program in the last 2 years (includes research studies involving memory training)
• Myocardial infarction, coronary artery bypass graft, or valve replacement within past 6 months
• Serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia
• Pulmonary embolism or deep venous thrombosis within past 6 months
• Stroke, hip fracture, hip or knee replacement, or spinal surgery within past 4 months
• Receiving physical therapy for gait, balance, or other lower extremity training
• Severe hypertension, e.g., systolic blood pressure over 160 mmHg, diastolic blood pressure over 110 mmHg
• Other temporary intervening events, such as sick spouse, bereavement, or recent move

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.