Seniors Health and Activity Research Program-Pilot

NCT00688155 | Completed Results DMC

• 2 other identifiers: IA01331R01AG029285-01
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function

Outcome Measures

Primary Outcomes (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.

  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.

  Changes from baseline at 4 months in z-scores.

Secondary Outcomes (2)

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

  Baseline to 4 months

• Composite Episodic Memory

  Change a 4 months

Study Arms (4)

Physical Activity Training

EXPERIMENTAL

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

Cognitive Training

EXPERIMENTAL

The Cognitive Training (CT) intervention was developed to improve consciously-controlled memory processing or recollection of episodic memory information.

Behavioral: Cognitive Training

Combined Intervention

EXPERIMENTAL

The Combined Intervention (PACT) was designed so that participants received both cognitive and physical activity training on the same day. .

Behavioral: Physical Activity Training; Behavioral: Cognitive Training

Healthy Aging Education

ACTIVE COMPARATOR

The Healthy Aging Education control intervention consisted of weekly lectures based on health education.

Behavioral: Healthy Aging Education

Interventions

Physical Activity Training BEHAVIORAL

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.

Combined Intervention; Physical Activity Training

Cognitive Training BEHAVIORAL

Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6.

Cognitive Training; Combined Intervention

Healthy Aging Education BEHAVIORAL

One 1-hour lecture each week for 3 months, then monthly.

Also known as: Healthy Aging

Healthy Aging Education

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (5)

• 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.

  PMID: 12661673 BACKGROUND

• 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.

  PMID: 16773952 BACKGROUND

• 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.

  PMID: 21615936 BACKGROUND

• 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.

  PMID: 23589390 BACKGROUND

• 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.

  PMID: 21229597 DERIVED

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

While large enough to meet its objectives, our pilot trial involved a modest sample size and short follow-up.

Results Point of Contact

• Title: Mark Espeland, PhD
• Organization: Wake Forest School of Medicine

mespelan@wakehealth.edu

336-761-2826

Study Officials

• Mark Espeland, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data collection related to study outcomes was performed by staff who were masked to intervention assignment.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 2, 2008
• Study Start: May 1, 2008
• Primary Completion: June 30, 2009
• Study Completion: June 30, 2010
• Last Updated: January 4, 2018
• Results First Posted: December 7, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: On request
• Access Criteria: Data sharing agreement.

Locations

US (1)