Sedentary LifestyleNCT02787655
Aerobic Exercise and Cognitive Training in Older Adults
A study testing Aerobic exercise + Cognitive Training Group and Cognitive training Only in people with Sedentary Lifestyle, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. It is hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Aerobic exercise + Cognitive Training Group and Cognitive training Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2013to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right handed
- English speaking
- Aged 18 to 89
- Sedentary as defined by < 120 min/week of aerobic exercise over prior 3 months
- Non-demented (MMSE 24)
Who cannot join
- Severe diabetes requiring insulin
- Cognitive-executive function deficit (MoCA < 26)
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
About this study
The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. It is hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability.
To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of executive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence.
Read the detailed description
Purpose: The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. Recent research demonstrated that older adults who participated in aerobic fitness training significantly increased their brain volume. Equally important, the demonstrated enhancement in brain size is related to improvement on specific cognitive tasks. For example, researchers demonstrated that 124 older adults randomly assigned to receive aerobic training experienced substantial improvement in cognitive performance tasks related to speed of processing and working memory. Similarly, neuroimaging studies showed that aerobically trained individuals increased brain activation during various cognitive tasks.
A growing body of research also demonstrates the beneficial effects of cognitive training in later life to promote a healthy brain. For example, researchers demonstrated cognitive interventions targeting memory, reasoning and speed of processing were effective to improve brain function. Unfortunately, despite these promising findings, the generalizability of cognitive training is limited. For example, researchers showed cognitive training tasks designed to improve reasoning, memory, planning, spatial skills and attention in over 11,000 participants demonstrated no transfer effects to untrained tasks, even when the tasks were closely related. The purpose of this study is to see if combing aerobic exercise and cognitive training can enhance the cognitive improvement of each. Specially, the investigators wish to determine if aerobic exercise done immediately before cognitive training can potentiate the improvement.
The investigators hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability.
Background: Currently the United States has over 23 million Veterans. Of this number, 39.1 percent are over the age of 65 a number that will greatly increase as a large percent of the US population ages. Unfortunately, many of these individuals will suffer from some form of age-related cognitive decline and/or mobility disability. Significantly, declining mental health and mobility disability are primary components of the expected 25 percent growth in health care cost related to the aging crisis in America. And, despite the fact that the United States federal government spends $100 billion dollars annually to cure and/or treat cognitive impairments, successful strategies to improve these impairments remain elusive. The proposed research will substantially advance the development of treatments for cognitive and mobility impairment because the goals explore an intervention that may potentially have pervasive effects on US Veterans quality of life and well-being from a physical as well as a cognitive standpoint.
Methods and Research Plan: To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of cognitive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence.
Baseline testing will consist of a battery of cognitive function that target verbal fluency, response inhibition, and working memory. Additionally, participant will undergo a structural and functional MRI. Participants will also be evaluated on their physical function as assessed by a 400 meter walk, balance tests, and questionnaires about their daily l functioning. And lastly, all participants will be assessed on their aerobic capacity and for visual outcomes and serum BDNF. Following the 12-week intervention all participants will be post tested in the same manner as the baseline testing.
- Conditions
- Sedentary Lifestyle
- Being tested
- Aerobic exercise + Cognitive Training Group, Cognitive training Only
- Keywords
- Aging
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise + Cognitive Training GroupBehavioural
stationary bicycling
Cognitive training OnlyBehavioural
20 minutes of cognitive training using Mindfit program
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise + Cognitive Training Group | Experimental | Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session; plus 20 minutes of cognitive training using Mindfit program Receives: Behavioral: Aerobic exercise + Cognitive Training Group |
| Cognitive Training Only Group | Active comparator | Cognitive Training Only Group. For this arm of the intervention, randomized participants followed the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise. To equalize contact/monitoring of the groups this group met for the same total duration time as the AE+CT group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises Receives: Behavioral: Cognitive training Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Executive Language Functions (Category Verbal Fluency)
The Category Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89. For Category Verbal Fluency, participants are asked to generate words from a category (e.g., colors) within 60 seconds. A higher change score represents better performance on the outcome.
Measured: change from pre and post separated by 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start1 Feb 2013
- Primary completion1 Apr 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joe R. Nocera, PhD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787655
- Sponsor's protocol ID
- B8034-W
- Status last verified
- Nov 2020
- First submitted
- 25 May 2016
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nocera J, Crosson B, Mammino K, McGregor KM. Changes in Cortical Activation Patterns in Language Areas following an Aerobic Exercise Intervention in Older Adults. Neural Plast. 2017;2017:6340302. doi: 10.1155/2017/6340302. Epub 2017 Mar 6.
PubMed 28367334
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise and Cognitive Training in Older Adults
- ClinicalTrials.gov ID
- NCT02787655
- Acronym / sponsor ID
- B8034-W
- Conditions
- Sedentary Lifestyle
- Keywords
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. It is hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability.
To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of executive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence.
Detailed description
Purpose: The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. Recent research demonstrated that older adults who participated in aerobic fitness training significantly increased their brain volume. Equally important, the demonstrated enhancement in brain size is related to improvement on specific cognitive tasks. For example, researchers demonstrated that 124 older adults randomly assigned to receive aerobic training experienced substantial improvement in cognitive performance tasks related to speed of processing and working memory. Similarly, neuroimaging studies showed that aerobically trained individuals increased brain activation during various cognitive tasks.
A growing body of research also demonstrates the beneficial effects of cognitive training in later life to promote a healthy brain. For example, researchers demonstrated cognitive interventions targeting memory, reasoning and speed of processing were effective to improve brain function. Unfortunately, despite these promising findings, the generalizability of cognitive training is limited. For example, researchers showed cognitive training tasks designed to improve reasoning, memory, planning, spatial skills and attention in over 11,000 participants demonstrated no transfer effects to untrained tasks, even when the tasks were closely related. The purpose of this study is to see if combing aerobic exercise and cognitive training can enhance the cognitive improvement of each. Specially, the investigators wish to determine if aerobic exercise done immediately before cognitive training can potentiate the improvement.
The investigators hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability.
Background: Currently the United States has over 23 million Veterans. Of this number, 39.1 percent are over the age of 65 a number that will greatly increase as a large percent of the US population ages. Unfortunately, many of these individuals will suffer from some form of age-related cognitive decline and/or mobility disability. Significantly, declining mental health and mobility disability are primary components of the expected 25 percent growth in health care cost related to the aging crisis in America. And, despite the fact that the United States federal government spends $100 billion dollars annually to cure and/or treat cognitive impairments, successful strategies to improve these impairments remain elusive. The proposed research will substantially advance the development of treatments for cognitive and mobility impairment because the goals explore an intervention that may potentially have pervasive effects on US Veterans quality of life and well-being from a physical as well as a cognitive standpoint.
Methods and Research Plan: To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of cognitive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence.
Baseline testing will consist of a battery of cognitive function that target verbal fluency, response inhibition, and working memory. Additionally, participant will undergo a structural and functional MRI. Participants will also be evaluated on their physical function as assessed by a 400 meter walk, balance tests, and questionnaires about their daily l functioning. And lastly, all participants will be assessed on their aerobic capacity and for visual outcomes and serum BDNF. Following the 12-week intervention all participants will be post tested in the same manner as the baseline testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise + Cognitive Training Group | Experimental | Behavioral: Aerobic exercise + Cognitive Training GroupExercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session; plus 20 minutes of cognitive training using Mindfit program |
| Cognitive Training Only Group | Active comparator | Behavioral: Cognitive training OnlyCognitive Training Only Group. For this arm of the intervention, randomized participants followed the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise. To equalize contact/monitoring of the groups this group met for the same total duration time as the AE+CT group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Right handed
- English speaking
- Aged 18 to 89
- Sedentary as defined by < 120 min/week of aerobic exercise over prior 3 months
- Non-demented (MMSE 24)
Key exclusion criteria (2 listed)
- Severe diabetes requiring insulin
- Cognitive-executive function deficit (MoCA < 26)
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 |
|---|---|---|
| Aerobic exercise + Cognitive Training Groupstationary bicycling | Behavioural | Aerobic Exercise + Cognitive Training Group |
| Cognitive training Only20 minutes of cognitive training using Mindfit program | Behavioural | Cognitive Training Only Group |
Primary outcome
Change Executive Language Functions (Category Verbal Fluency)
Time frame: change from pre and post separated by 12 weeks
The Category Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89. For Category Verbal Fluency, participants are asked to generate words from a category (e.g., colors) within 60 seconds. A higher change score represents better performance on the outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28367334Nocera J, Crosson B, Mammino K, McGregor KM. Changes in Cortical Activation Patterns in Language Areas following an Aerobic Exercise Intervention in Older Adults. Neural Plast. 2017;2017:6340302. doi: 10.1155/2017/6340302. Epub 2017 Mar 6.
- Individual participant dataSharing planned: No
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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.
Joe R. Nocera, PhD principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise + Cognitive Training Group and Cognitive training Only in people with Sedentary Lifestyle, run by VA Office of Research and Development 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 5 inclusion and 2 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 16 Nov 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?
Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change Executive Language Functions (Category Verbal Fluency) (time frame: change from pre and post separated by 12 weeks). 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 NCT02787655, which also lists 1 linked publication.
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 16 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.