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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395837
• Other study ID #: #S2004.004
• Status: Completed
• Phase: N/A
• First received: November 1, 2006
• Last updated: November 1, 2006
• Start date: September 2004
• Est. completion date: May 2006

Study information

• Verified date: November 2006
• Source: St. Anthony's Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: IRB: St Anthony's Health Care, USA
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Aerobic exercise

Locations

Country	Name	City	State
United States	Carillon Wellness Center	St Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
St. Anthony's Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance (memory, psychomotor speed, reaction time, attention, cognitive flexibility)
Secondary	Cholesterol profile
Secondary	Weight change
Secondary	Body fat change
Secondary	Changes in fitness (strength, flexibility, VO2max)