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

November 1, 2006 updated by: St. Anthony's Health Care

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • St Petersburg, Florida, United States, 33716
        • Carillon Wellness Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Anthony's Health Care

Investigators

  • Principal Investigator: Steven C Masley, Medical Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

November 1, 2006

First Submitted That Met QC Criteria

November 1, 2006

First Posted (Estimate)

November 3, 2006

Study Record Updates

Last Update Posted (Estimate)

November 3, 2006

Last Update Submitted That Met QC Criteria

November 1, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • #S2004.004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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