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

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ClinicalTrials.gov Identifier: NCT00395837
Recruitment Status : Completed
First Posted : November 3, 2006
Last Update Posted : November 3, 2006
Information provided by:
St. Anthony's Health Care

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.

Condition or disease Intervention/treatment
Aging Behavioral: Aerobic exercise

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Lifestyle Changes in Modifying Practical Markers of Wellness and Aging
Study Start Date : September 2004
Estimated Study Completion Date : May 2006

Primary Outcome Measures :
  1. Cognitive performance (memory, psychomotor speed, reaction time, attention, cognitive flexibility)

Secondary Outcome Measures :
  1. Cholesterol profile
  2. Weight change
  3. Body fat change
  4. Changes in fitness (strength, flexibility, VO2max)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395837

United States, Florida
Carillon Wellness Center
St Petersburg, Florida, United States, 33716
Sponsors and Collaborators
St. Anthony's Health Care
Principal Investigator: Steven C Masley Medical Director

ClinicalTrials.gov Identifier: NCT00395837     History of Changes
Other Study ID Numbers: #S2004.004
First Posted: November 3, 2006    Key Record Dates
Last Update Posted: November 3, 2006
Last Verified: November 2006

Keywords provided by St. Anthony's Health Care:
Aerobic exercise