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

This study has been completed.
Sponsor:
Information provided by:
St. Anthony's Health Care
ClinicalTrials.gov Identifier:
NCT00395837
First received: November 1, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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 Intervention
Aging
 Behavioral: Aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Lifestyle Changes in Modifying Practical Markers of Wellness and Aging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Anthony's Health Care:

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

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

Estimated Enrollment: 56
Study Start Date: September 2004
Estimated Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395837

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

No publications provided

ClinicalTrials.gov Identifier: NCT00395837     History of Changes
Other Study ID Numbers: #S2004.004
Study First Received: November 1, 2006
Last Updated: November 1, 2006
Health Authority: IRB: St Anthony's Health Care, USA

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

ClinicalTrials.gov processed this record on June 17, 2013