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Clinical Trials/NCT00395837
NCT00395837CompletedNot Applicable

Efficacy of Lifestyle Changes in Modifying Practical Markers of Wellness and Aging

St. Anthony's Health Care2 sites in 1 country56 target enrollmentStarted: September 1, 2004Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
56
Locations
2
Primary Endpoint
Cognitive performance (memory, psychomotor speed, reaction time, attention, cognitive flexibility)

Study Overview

Brief Summary

To assess the impact of lifestylel changes upon measures of wellness and aging, in particular weight change, fitness measures, and cognitive performance. The hypothesis was that aerobic exercise would improve mental performance and measures of fitness.

Detailed Description

A 10-week, randomized control study conducted in a wellness center in St. Petersburg, Florida. Adults age 21-65, exercising less than 3 days/week. 56 subjects were randomized to a control or an intervention group. Subjects followed a diet with >30 grams of fiber and <16 grams of saturated fat daily, and were taught to reach 70-85% of their maximum heart rate 5-6 days/week, and to perform strength training 3 days/week, plus were asked to participate in 10-20 minutes of stress management activities daily. The study was designed to determine body composition, maximal aerobic capacity (VO2 max), total cholesterol/high-density lipoprotein (TC/HDL), and cognition.

Specific aspects ofcognitive performance were noted to increase with increasing levels of aerobic activity, but not with strength training, dietary fiber change, or stress managment.

Having established that the treatment group would exercise at different levels of intensity, additional subjects were recruited, and the cognitive performance of no exercise, moderate aerobic exercise, and frequent aerobic exercise could be compared with specific domains of cognitive performance: memory, psychomotor speed, reaction time, attention, and cognitive flexibility. The St Anthony's Institutional Review Board approved this research project.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • able to exercise 5-6 days per week

Exclusion Criteria

  • Free of major medical conditions, unable to exercise aerobically 5-6 days per week

Outcomes

Primary Outcomes

Cognitive performance (memory, psychomotor speed, reaction time, attention, cognitive flexibility)

Secondary Outcomes

  • Weight change
  • Body fat change
  • Changes in fitness (strength, flexibility, VO2max)
  • Cholesterol profile

Investigators

Sponsor
St. Anthony's Health Care
Sponsor Class
Other

Study Sites (2)

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