NCT02068612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2018

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

4.6 years

First QC Date

February 19, 2014

Last Update Submit

March 25, 2020

Conditions

Keywords

Executive function,cardiovascular fitness,cognitive function

Outcome Measures

Primary Outcomes (1)

  • Cognitive Function

    1. Functional connectivity is measured via having participants lie in a magnetic resonance imaging scanner and passively stare at a centrally-positioned fixation crosshair for 8 min while their brain activity is recorded. 2. Executive function will be measured with 3 tasks characterized by the three domains of executive function: updating, shifting, and inhibition. For updating, we will utilize the Keep Track task,for shifting, we will use the Category Switch Task, and for inhibition we will use the Stroop task.

    4 months

Study Arms (2)

MICT + IT

EXPERIMENTAL

Moderate Intensity Continuous Training+Interval Training

Behavioral: Moderate Intensity Continuous Training+Interval Training

LICT

ACTIVE COMPARATOR

Low Intensity Continuous Training

Behavioral: Low Intensity Continuous Training

Interventions

Also known as: MICT+IT
MICT + IT
Also known as: LICT
LICT

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Related Publications (4)

  • Gust CJ, Martin-Willett R, Gibson LP, Giordano G, Seals DR, Bryan AD. Effects of aerobic exercise of different intensities on the social, emotional, and financial functioning of healthy older adults: results from a 16-week exercise randomized control trial. Geroscience. 2025 Apr 21. doi: 10.1007/s11357-025-01655-0. Online ahead of print.

  • 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.

  • 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.

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

April 1, 2014

Primary Completion

November 13, 2018

Study Completion

December 3, 2018

Last Updated

March 27, 2020

Record last verified: 2020-03

Locations