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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00891488
Other study ID # AG0119
Secondary ID 1R03AG030551-01A
Status Completed
Phase N/A
First received April 30, 2009
Last updated August 2, 2010
Start date July 2008
Est. completion date May 2010

Study information

Verified date July 2010
Source Kronos Longevity Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The purpose of this study is to test the hypothesis that physiological adaptations to regular exercise training (i.e. physical fitness) attenuates age-related decline in stress resilience to both oxidative stress and the neuroendocrine responses to psychosocial stress.


Description:

Aging is associated with diminished stress resilience, as in reduced ability to manage or recover from acute changes in homeostasis. Increased oxidative damage to cells and tissues and dysregulation of stress hormones have been linked to age-associated chronic diseases including atherosclerosis, cancer, cardiovascular disease and Alzheimer's disease. Interventions to improve the body's resistance to stress, resulting in lower oxidative stress and better regulation of the stress hormones, may prevent or delay the onset of age-related diseases and improve quality of life.

Oxidative stress is believed to be a key mechanism in the aging process, with free radicals also implicated in many pathological processes. Similarly, dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis is thought to play a role in aging and is linked to the increased risk for age-related chronic disease.

The hormesis theory suggests that a certain amount of stress can lead to better survival and reduced tissue damage following a subsequent, more severe stress. One way to stress the system is through acute exercise. Regular exercise training, however, results in adaptive responses that increase the tolerance for successive (exercise) stress.

A relevant question is whether adaptations to regular exercise training translate to greater resilience to psychosocial stress and an increased capacity to resist acute oxidative stress, thereby providing increased protection from diseases associated with dysregulation of these systems.

This study will investigate stress resilience in two areas related to aging: oxidative stress and the neuroendocrine response to psychosocial stress. The effects of physical fitness on oxidative stress compensation and neuroendocrine stress reactivity will be determined by comparing fit and unfit older men and women. The overall aim of this study is to provide enhanced understanding of the mechanisms by which physical fitness modifies stress resilience in older men and women.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

- Men and post-menopausal women, ages 60-80 years

- Generally good health by self-report

Exclusion Criteria:

- Estrogen or testosterone supplementation within the previous 6 months

- Current smoker

- Body Mass Index (BMI) > 32 kg/m2

- Any chronic illness that could affect cortisol levels, including diabetes mellitus, liver or renal disease

- Evidence of a previous myocardial infarction within the last 6 months by EKG or history of angina or shortness of breath

- Clinically significant arrhythmia on a resting EKG or significant EKG changes during the baseline VO2max test

- Any other condition that would contraindicate maximal exercise testing, including elevated blood pressure at rest (systolic BP >140 or diastolic BP >90 mm Hg on at least 2 measurements, at least 10 minutes apart) or musculoskeletal problems

- Depression as measured by the Beck Depression Inventory (BDI score >17)

- Use of anti-oxidant supplements, in excess of standard multi-vitamins (1 tablet/day)

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Kronos Longevity Research Institute Phoenix Arizona

Sponsors (2)

Lead Sponsor Collaborator
Kronos Longevity Research Institute National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Fatouros IG, Jamurtas AZ, Villiotou V, Pouliopoulou S, Fotinakis P, Taxildaris K, Deliconstantinos G. Oxidative stress responses in older men during endurance training and detraining. Med Sci Sports Exerc. 2004 Dec;36(12):2065-72. — View Citation

Finkel T, Holbrook NJ. Oxidants, oxidative stress and the biology of ageing. Nature. 2000 Nov 9;408(6809):239-47. Review. — View Citation

Traustadóttir T, Bosch PR, Matt KS. The HPA axis response to stress in women: effects of aging and fitness. Psychoneuroendocrinology. 2005 May;30(4):392-402. Epub 2005 Jan 11. — View Citation

Vincent HK, Bourguignon C, Vincent KR. Resistance training lowers exercise-induced oxidative stress and homocysteine levels in overweight and obese older adults. Obesity (Silver Spring). 2006 Nov;14(11):1921-30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary F2-isoprostane response to an oxidative challenge (forearm ischemia-reperfusion trial) Visit 4 No
Primary Cortisol response (plasma and salivary) to a psychosocial laboratory stressor--Trier Social Stress Test (TSST) Visit 3 No
Secondary Total antioxidant capacity Visit 4 No
Secondary ACTH response to TSST Visit 3 No
Secondary Heart rate response to the TSST Visit 3 No
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