N/A
N=73
Seniors Health and Activity Research Program-Pilot
Cognitive Function
Bottom Line
View on ClinicalTrials.gov: NCT00688155 ↗Enrolled (actual)
73
Serious AEs
1.4%
Results posted
Dec 2017
Primary outcome: Primary: Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. — 0.71; 0.62; 0.71; 0.65 z-scores (e.g.Standard Deviation Units) — p=0.66
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical Activity Training (Behavioral); Cognitive Training (Behavioral); Healthy Aging Education (Behavioral)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Cognitive Function in Z-scores (i.e. Which Converts Raw Data to Standard Deviation (SD) Units: [Score-mean]/SD]). This Composite is Formed by Averaging the Z-scores From Individual Tests. |
0.71; 0.62; 0.71; 0.65 | 0.66 |
| SECONDARY Change in Executive Function: Z-score Formed by Averaging the Individual Z-scores From the Five Tests Listed Below. |
0.32; 0.58; 0.60; 0.58 | — |
| SECONDARY Composite Episodic Memory |
0.84; 0.42; 0.56; 0.47 | 0.23 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Participation in another intervention trial; participation in an observational study may be permitted
- Inability to commit to intervention schedule requirements
Data sourced from ClinicalTrials.gov (NCT00688155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.