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

March 25, 2020 updated by: Angela Bryan, University of Colorado, Boulder
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado Boulder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MICT + IT
Moderate Intensity Continuous Training+Interval Training
Behavioral: Moderate Intensity Continuous Training+Interval Training
Other Names:
  • MICT+IT
Active Comparator: LICT
Low Intensity Continuous Training
Behavioral: Low Intensity Continuous Training
Other Names:
  • LICT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Boulder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

November 13, 2018

Study Completion (Actual)

December 3, 2018

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Actual)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1R01AG043452-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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