NCT00688155

Seniors Health and Activity Research Program-Pilot

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 70 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cognitive Function

Interventions

Type	Name	Description
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.
BEHAVIORAL	Healthy Aging Education	One 1-hour lecture each week for 3 months, then monthly.

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-06-30
• Completion: 2010-06-30
• First posted: 2008-06-02
• Last updated: 2018-01-04
• Results posted: 2017-12-07

Locations

1 site across 1 country: United States