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Enhancing Function in Later Life: Exercise and Functional Network Connectivity (FORCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02068612
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Angela Bryan, University of Colorado, Boulder

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.

Condition or disease Intervention/treatment Phase
Aging Behavioral: Moderate Intensity Continuous Training+Interval Training Behavioral: Low Intensity Continuous Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Enhancing Function in Later Life: Exercise and Functional Network Connectivity
Study Start Date : April 2014
Actual Primary Completion Date : November 13, 2018
Actual Study Completion Date : December 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MICT + IT
Moderate Intensity Continuous Training+Interval Training
Behavioral: Moderate Intensity Continuous Training+Interval Training
Other Name: MICT+IT

Active Comparator: LICT
Low Intensity Continuous Training
Behavioral: Low Intensity Continuous Training
Other Name: LICT




Primary Outcome Measures :
  1. Cognitive Function [ Time Frame: 4 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068612


Locations
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United States, Colorado
University of Colorado Boulder
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
  Study Documents (Full-Text)

Documents provided by Angela Bryan, University of Colorado, Boulder:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Angela Bryan, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT02068612    
Other Study ID Numbers: 1R01AG043452-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Keywords provided by Angela Bryan, University of Colorado, Boulder:
Executive function,
cardiovascular fitness,
cognitive function