Clinical trial NCT00688155: Seniors Health and Activity Research Program-Pilot
Official title: Seniors Health and Activity Research Program-Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-06-02
Enrollment: 73
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants were randomly assigned, with equal probability to one of four conditions: an educational control condition, moderate-intensity physical activity training, repetition lag cognitive training, or both physical activity and repetitive lag training.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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.
timeFrame: Changes from baseline at 4 months in z-scores.
Secondary outcomes:
measure: Change in Executive Function: Z-score Formed by Averaging the Individual Z-scores From the Five Tests Listed Below.
timeFrame: Baseline to 4 months
measure: Composite Episodic Memory
timeFrame: Change a 4 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mark Espeland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
citation: Espeland MA, Rapp SR, Robertson J, Granek I, Murphy C, Albert M, Bassford T; Women's Health Initiative Memory Study. Benchmarks for designing two-stage studies using modified mini-mental state examinations: experience from the Women's Health Initiative Memory Study. Clin Trials. 2006;3(2):99-106. doi: 10.1191/1740774506cn140oa.
citation: Legault C, Jennings JM, Katula JA, Dagenbach D, Gaussoin SA, Sink KM, Rapp SR, Rejeski WJ, Shumaker SA, Espeland MA; SHARP-P Study Group. 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. BMC Geriatr. 2011 May 26;11:27. doi: 10.1186/1471-2318-11-27.
citation: Espeland MA, Katula JA, Rushing J, Kramer AF, Jennings JM, Sink KM, Nadkarni NK, Reid KF, Castro CM, Church T, Kerwin DR, Williamson JD, Marottoli RA, Rushing S, Marsiske M, Rapp SR; LIFE Study Group. Performance of a computer-based assessment of cognitive function measures in two cohorts of seniors. Int J Geriatr Psychiatry. 2013 Dec;28(12):1239-50. doi: 10.1002/gps.3949. Epub 2013 Apr 16.
citation: Espeland MA, Rapp SR, Katula JA, Andrews LA, Felton D, Gaussoin SA, Dagenbach D, Legault C, Jennings JM, Sink KM; SHARP-P Study Group. Telephone interview for cognitive status (TICS) screening for clinical trials of physical activity and cognitive training: the seniors health and activity research program pilot (SHARP-P) study. Int J Geriatr Psychiatry. 2011 Feb;26(2):135-43. doi: 10.1002/gps.2503.