Seniors Health and Activity Research Program-Pilot

Not Applicable

Completed

Conditions: Cognitive Function

Interventions: Behavioral: Healthy Aging Education
Behavioral: Physical Activity Training
Behavioral: Cognitive Training

Registration Number: NCT00688155

Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description: Evidence from small or uncontrolled studies indicates that physical exercise and cognitive training have considerable promise as prevention strategies, to the extent that they are often recommended; however, their efficacy has not been established by an adequately powered randomized clinical trial.

This pilot study will provide the experience and data to assess whether physical activity and cognitive training separately improve cognitive function over 6 months. It will also determine whether a combination intervention holds promise beyond individual interventions without compromising adherence, and will provide information necessary to design a well-organized and efficient full scale, multi-center randomized clinical trial.

The Physical Activity Training (PAT) will consist of center-based and home-based sessions to include aerobic, strength, flexibility, and balance training. The actual time spent exercising will vary from person to person and will also vary depending on what stage of the study they are in.

The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information and produces changes in performance that transfer to executive function, such as working memory, planning and memory monitoring, as well as long term item memory and cognitive processing speed.

The Healthy Aging Education (HAE) control will combine health education-based lectures with light stretching and toning. HAE will include an experiential component, in which participants will learn how to take charge of their health and seek out appropriate medical services and information. Topics such as medications, foot care, traveling and nutrition will be covered.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 73

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Combined Intervention	Cognitive Training	The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. .
Healthy Aging Education	Healthy Aging Education	The Healthy Aging Education control intervention consisted of weekly lectures based on health education.
Combined Intervention	Physical Activity Training	The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. .
Physical Activity Training	Physical Activity Training	The Physical Activity Training ((PAT) intervention consisted of center-based and home-based sessions comprised of aerobic, strength, flexibility, and balance training with a targeted duration of 150 mins/wk.
Cognitive Training	Cognitive Training	The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information.

Primary Outcome Measures

Name	Time	Method
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.	Changes from baseline at 4 months in z-scores.	6 measures of executive functioning: Self-Ordered Pointing task (24): working memory 1- and 2-Back tests (25-26): working memory Eriksen flanker (27): response inhibition Task Switching (28): attentional flexibility Trail Making (29): executive function z-score=(raw score-mean)/standard deviation 4 measures of episodic memory Hopkins Verbal Learning Test (30) Wechsler Memory Scale-III (31) A composite of 10 scores: dividing each's difference from the baseline mean by the baseline SD, averaging the 6 executive function and 4 episodic memory z-transformed measures, and norming to have SD 1. 24. Petrides. Neuropsych 1982;20:249-62. 25. Dobbs. Psychol Aging 1989;4:500-3. 26. Jonides. J Cog Neurosci 1997;9:462-75. 27. Ericksen. Br J Sports Med 2009;43:22-4. 28. Kramer. Acta Psychologica 1999;101:339-78. 29. Reitan. Per Motor Skills 1958;8:271-6. 30. Brandt. Clin Neuropsych 1991;5:125-42. 31. Wechsler D.1997. Psychological Corporation, Harcourt, Inc: San Antonio.

Secondary Outcome Measures

Name	Time	Method
Change in Executive Function: Z-score Formed by Averaging the Individual Z-scores From the Five Tests Listed Below.	Baseline to 4 months	Composite of 5 tasks: Self-Ordered Pointing Task of planning, working memory, and monitoring. Subjects view 16 abstract shapes and choose a shape so that each is selected by the 16th trial and none is chosen more than once. (Eriksen, Percept Psychophysiology 1974;16:143-49). N-Back Test of working memory. Subjects see individual letters and indicate whether the letter is the same as the nth back letter, with n equal to 1 and 2. (Dobbs, Psychol Aging 1989;4:500-3.) Eriksen flanker task of response incompatibility. Subjects see an arrow facing either right or left and indicate the direction.The target displays can be neutral congruent, or incongruent. (Eriksen, Percept Psychophys 1974;16:143-49.) Trail Making Test-Part B of alternating attention. Subjects connect 25 labeled circles and are scored by completion time. The lower the scores the better the performance. See details in the primary outcome. Raw scores for each test were converted to z-scores.
Composite Episodic Memory	Change a 4 months	Composite of 4 components. The Hopkins Verbal Learning Test (HVLT) of verbal learning. Subjects hear 12 words and repeat as many as possible. This is repeated twice for a total of 3 trials. 20 mins later the subject is asked to recall as many words as possible. Subjects also do a recognition trial with 24 words. Scores for immediate and delayed recall, and recognition are calculated.(Brandt J. Clin Neuropsych 1991;5:125-42). The Logical Memory (LM) test The LM test has 2 parts. In Part 1, subjects hear a story and recall as many pieces as possible immediately and after a 30 minute delay. Subjects receive a story unit score for accuracy of re-telling story details and a thematic score for recalling story themes. The higher the scores the better the performance. ( Wechsler D. The Wechsler Memory Scale-3rd Edition (WHM-III). Psycholog Corp, Harcourt, Inc.) Individual scores are converted to z-scores and averaged to form the composite.