AgingFORCENCT02068612
Enhancing Function in Later Life: Exercise and Functional Network Connectivity
A study testing Moderate Intensity Continuous Training+Interval Training and Low Intensity Continuous Training in people with Aging, run by University of Colorado, Boulder at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Moderate Intensity Continuous Training+Interval Training and Low Intensity Continuous Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 3 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
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.
- Conditions
- Aging
- Being tested
- Moderate Intensity Continuous Training+Interval Training, Low Intensity Continuous Training
- Keywords
- Executive function,, cardiovascular fitness,, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity Continuous Training+Interval TrainingBehavioural
Also called MICT+IT
Low Intensity Continuous TrainingBehavioural
Also called LICT
| Study group | Role | What they receive |
|---|---|---|
| MICT + IT | Experimental | Moderate Intensity Continuous Training+Interval Training Receives: Behavioral: Moderate Intensity Continuous Training+Interval Training |
| LICT | Active comparator | Low Intensity Continuous Training Receives: Behavioral: Low Intensity Continuous Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
- 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.
- 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startApr 2014
- Primary completion13 Nov 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Bryan, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068612
- Sponsor's protocol ID
- 1R01AG043452-01A1
- Acronym
- FORCE
- Status last verified
- Mar 2020
- First submitted
- 19 Feb 2014
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. 2026 Feb;48(1):391-403. doi: 10.1007/s11357-025-01655-0. Epub 2025 Apr 21.
PubMed 40259150Martin-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.
PubMed 34062261Martin-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.
PubMed 33271506YorkWilliams 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.
PubMed 32553024
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Function in Later Life: Exercise and Functional Network Connectivity
- ClinicalTrials.gov ID
- NCT02068612
- Acronym / sponsor ID
- FORCE / 1R01AG043452-01A1
- Conditions
- Aging
- Keywords
- Executive function,, cardiovascular fitness,, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MICT + IT | Experimental | Behavioral: Moderate Intensity Continuous Training+Interval TrainingModerate Intensity Continuous Training+Interval Training |
| LICT | Active comparator | Behavioral: Low Intensity Continuous TrainingLow Intensity Continuous Training |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate Intensity Continuous Training+Interval TrainingAlso: MICT+IT | Behavioural | MICT + IT |
| Low Intensity Continuous TrainingAlso: LICT | Behavioural | LICT |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Derived from this study: PubMed 40259150Gust 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. 2026 Feb;48(1):391-403. doi: 10.1007/s11357-025-01655-0. Epub 2025 Apr 21.
- Derived from this study: PubMed 34062261Martin-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.
- Derived from this study: PubMed 33271506Martin-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.
- Derived from this study: PubMed 32553024YorkWilliams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Continuous Training+Interval Training and Low Intensity Continuous Training in people with Aging, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02068612, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.