Seniors Health and Activity Research Program-Pilot (SHARP-P)

• ClinicalTrials.gov Identifier: NCT00688155
• Recruitment Status: Completed
• First Posted: June 2, 2008
• Results First Posted: December 7, 2017
• Last Update Posted: January 4, 2018
• Sponsor: Wake Forest University Health Sciences
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cognitive Function	Behavioral: Physical Activity Training; Behavioral: Cognitive Training; Behavioral: Healthy Aging Education	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: Data collection related to study outcomes was performed by staff who were masked to intervention assignment.
• Primary Purpose: Prevention
• Official Title: Seniors Health and Activity Research Program-Pilot
• Actual Study Start Date: May 2008
• Actual Primary Completion Date: June 30, 2009
• Actual Study Completion Date: June 30, 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: Physical Activity Training; Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.
Experimental: Cognitive Training; The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information.	Behavioral: Cognitive Training; Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6.
Experimental: Combined Intervention; The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. .	Behavioral: Physical Activity Training; Two 1-hour center and two 15- to 45-minute home-based training sessions per week to include aerobic, strength, flexibility, and balance training for 6 months. The ultimate goal is to accumulate 150 minutes of walking per week between center and home-based sessions.; Behavioral: Cognitive Training; Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6.
Active Comparator: Healthy Aging Education; The Healthy Aging Education control intervention consisted of weekly lectures based on health education.	Behavioral: Healthy Aging Education; One 1-hour lecture each week for 3 months, then monthly.; Other Name: Healthy Aging

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 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 :

1. Change in Executive Function: Z-score Formed by Averaging the Individual Z-scores From the Five Tests Listed Below. [ Time Frame: 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.

2. Composite Episodic Memory [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 70 Years to 85 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Mark Espeland, PhD; Wake Forest University Health Sciences

More Information

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00688155
• Other Study ID Numbers: IA0133; 1R01AG029285-01 ( U.S. NIH Grant/Contract )
• First Posted: June 2, 2008
• Results First Posted: December 7, 2017
• Last Update Posted: January 4, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Available on request and development of a data sharing agreement.
• Supporting Materials: Study Protocol; Informed Consent Form (ICF)
• Time Frame: On request
• Access Criteria: Data sharing agreement.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No