Clinical trial NCT02068612: Enhancing Function in Later Life: Exercise and Functional Network Connectivity
Official title: Enhancing Function in Later Life: Exercise and Functional Network Connectivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Executive function,
cardiovascular fitness,
cognitive function
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 317
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Physiological and neurocognitive changes experienced as a result of increasing age may influence socioemotional functioning and economic behaviors, yet, the mechanisms through which these changes occur are not well understood. Studies have also shown that aerobic exercise may protect against age-related cognitive decline in other domains. This research is designed to test the hypothesis that aerobic exercise will enhance social, emotional and economic functioning in older adults, and that these effects will occur via the effect of exercise on neurocognitive structure and function assessed via magnetic resonance imaging (MRI). Advancing our knowledge of the mechanisms that influence emotional, social and economic functioning could inform the development of targeted treatments and prevention programs for older adults.


Eligibility criteria: Inclusion Criteria:

* Age 25-35 for younger adults, and age 60 or over for older adults
* Sedentary (i.e., \< 60 minutes per week of moderate physical activity in the past 6-months)
* Able to make fewer than 3 errors on the Pfeiffer Mental Status192
* Willing to accept random assignment to condition (older adults)
* Physically capable of safely engaging in moderate exercise activity (i.e., no injuries, physical impairments, or pre-existing contraindications) as assessed by a study physician
* Able to successfully complete a maximal exercise test without evidence of cardiac or other abnormalities
* Planning to remain in the Boulder-Denver metro area for the next 4 months (older adults)

Exclusion Criteria:

* Are a heavy smoker (\>20 pack years)
* Are diabetic
* Have a body size exceeding the capacity of the magnetic resonance imaging machine (approximately 23" in diameter)
* Are on antipsychotic medications
* Are currently under treatment for any psychiatric disorder, including clinical depression, Alzheimer's, or dementia
* Are currently pregnant
* Have magnetic resonance imaging contraindications (i.e., non-removable metallic implants, claustrophobia, traumatic brain injury, current pregnancy, etc.)

Primary outcomes:
measure: Cognitive Function
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
References:
citation: Martin-Willett R, Morris B, Wilcox R, Giordano G, Andrews-Hanna J, Banich M, Bryan AB. The influence of a 16-week exercise program, APOE status, and age on executive function task performance: A randomized trial. Exp Gerontol. 2021 Sep;152:111431. doi: 10.1016/j.exger.2021.111431. Epub 2021 May 29.
citation: Martin-Willett R, Ellingson JE, Fries J, Helmuth T, Karoly H, Giordano G, Calhoun VD, Bryan AD. Few Structural Brain Changes Associated With Moderate-Intensity Interval Training and Low-Intensity Continuous Training in a Randomized Trial of Fitness and Older Adults. J Aging Phys Act. 2021 Jun 1;29(3):505-515. doi: 10.1123/japa.2019-0352. Epub 2020 Dec 2.
citation: YorkWilliams SL, Gibson LP, Gust CJ, Giordano G, Hutchison KE, Bryan AD. Exercise Intervention Outcomes with Cannabis Users and Nonusers Aged 60 and Older. Am J Health Behav. 2020 Jul 1;44(4):420-431. doi: 10.5993/AJHB.44.4.5.