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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00688155 |
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 |
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Cognitive Function |
Behavioral: Physical Activity Training (PAT) Behavioral: Cognitive Training (CT) Behavioral: Healthy Aging Education (HAE) |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Factorial Assignment, Safety/Efficacy Study |
Official Title: | Seniors Health and Activity Research Program-Pilot |
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 |
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PAT: Experimental |
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.
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CT: Experimental |
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.
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PACT: Experimental |
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.
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HAE: Active Comparator |
Behavioral: Healthy Aging Education (HAE)
One 1-hour lecture each week for 3 months, then monthly.
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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.
Ages Eligible for Study: | 70 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Debbie Felton, MS | 336-713-5274 | dfelton@wfubmc.edu |
Contact: Lee Ann Andrews | 336-713-5267 | landrews@wfubmc.edu |
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 |
Principal Investigator: | Mark Espeland, PhD | Wake Forest University |
Responsible Party: | Wake Forest University Health Sciences ( Mark Espeland, PhD ) |
Study ID Numbers: | IA0133, 1R01AG029285-01A1 |
Study First Received: | May 29, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00688155 |
Health Authority: | United States: Federal Government |