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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00688155
First received: May 29, 2008
Last updated: November 13, 2008
Last verified: November 2008
  Purpose

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 Intervention
Cognitive Function
Behavioral: Physical Activity Training (PAT)
Behavioral: Cognitive Training (CT)
Behavioral: Healthy Aging Education (HAE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Seniors Health and Activity Research Program-Pilot

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Composite of five executive functioning and four episodic memory measures that have been previously validated [ Time Frame: Baseline, 2 months, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Speed of processing, visuospatial skills and verbal fluency [ Time Frame: Baseline, 2 months, and 6 months ] [ Designated as safety issue: No ]
  • Perceived cognitive functioning problems and quality of life [ Time Frame: Baseline, 2 months, and 6 months ] [ Designated as safety issue: No ]
  • Domain scores [executive function (five tests); immediate memory (two tests); delayed memory (two tests)] [ Time Frame: Baseline, 2 months, and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PAT Behavioral: Physical Activity Training (PAT)
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: CT Behavioral: Cognitive Training (CT)
Two 1-hour sessions per week for the first two months and then one 1-hour session per week for months 3-6.
Experimental: PACT Behavioral: Physical Activity Training (PAT)
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 (CT)
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: HAE Behavioral: Healthy Aging Education (HAE)
One 1-hour lecture each week for 3 months, then monthly.

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

Ages Eligible for Study:   70 Years to 85 Years
Genders Eligible for Study:   Both
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, ALS, or prior diagnosis of 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 NYHA 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, CABG, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688155

Contacts
Contact: Debbie Felton, MS 336-713-5274 dfelton@wfubmc.edu
Contact: Lee Ann Andrews 336-713-5267 landrews@wfubmc.edu

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Debbie Felton, MS    336-713-5274    dfelton@wfubmc.edu   
Contact: Lee Ann Andrews    336-713-5267    landrews@wfubmc.edu   
Principal Investigator: Mark Espeland, PhD         
Sub-Investigator: Janine Jennings, PhD         
Sub-Investigator: Jeff Katula, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Espeland, PhD Wake Forest School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Espeland, PhD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00688155     History of Changes
Other Study ID Numbers: IA0133, 1R01AG029285-01A1
Study First Received: May 29, 2008
Last Updated: November 13, 2008
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on November 27, 2014