AgingNCT00395837
Efficacy of Lifestyle Changes in Modifying Practical Markers of Wellness and Aging.
A study testing Aerobic exercise in people with Aging, run by St. Anthony's Health Care at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to exercise 5-6 days per week
Who cannot join
- Free of major medical conditions, unable to exercise aerobically 5-6 days per week
Trial locations and contacts
1 site in 1 country.
United States1 site
Carillon Wellness Center
St. Petersburg, Florida, 33716
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging
- Being tested
- Aerobic exercise
- Keywords
- Aging, Wellness, Aerobic exercise, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance (memory, psychomotor speed, reaction time, attention, cognitive flexibility)
Secondary outcomes (4)
Cholesterol profile
Weight change
Body fat change
Changes in fitness (strength, flexibility, VO2max)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startSep 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants
Sponsor and investigators
- Lead sponsor
- St. Anthony's Health Care
- Sponsor type
- University, hospital or other
- Investigators
- Steven C Masley, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395837
- Sponsor's protocol ID
- #S2004.004
- Status last verified
- Nov 2006
- First submitted
- 1 Nov 2006
- Last updated
- 3 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lifestyle Changes in Modifying Practical Markers of Wellness and Aging
- ClinicalTrials.gov ID
- NCT00395837
- Acronym / sponsor ID
- #S2004.004
- Conditions
- Aging
- Keywords
- Aging, Wellness, Aerobic exercise, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- St. Anthony's Health CareUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- May 2006
- First posted
- 3 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- able to exercise 5-6 days per week
Key exclusion criteria (1 listed)
- Free of major medical conditions, unable to exercise aerobically 5-6 days per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise | Behavioural | – |
Primary outcome
Cognitive performance (memory, psychomotor speed, reaction time, attention, cognitive flexibility)
4 secondary outcomes
Cholesterol profile
Weight change
Body fat change
Changes in fitness (strength, flexibility, VO2max)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven C Masley principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Aging, run by St. Anthony's Health Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance (memory, psychomotor speed, reaction time, attention, cognitive flexibility). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2006.