Healthy AgingNCT04120792
The Aerobic and Cognitive Training System
A study testing Simultaneous exercise and cognitive training, Exercise training and Cognitive Training in people with Healthy Aging, run by University of Arizona.
Trial summary
This study will determine the effects of simultaneous exercise and cognitive training on cognitive function in healthy older adults. Specifically, this study will compare the use of a tablet-based cognitive training system while exercising with exercise alone, cognitive training alone, and a neutral control condition… Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Simultaneous exercise and cognitive training, Exercise training and Cognitive Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 20 Nov 2017
- 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 60 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy, age 60-74, and a written statement from their primary care physician indicating that they are able to participate in the 12-week exercise program.
Who cannot join
- Subjects will be excluded from participating in the study if they express significant concerns about their memory or declines in other cognitive abilities, if they are not English speaking, or if they have histories of significant major neurological, psychiatric, or medical disorder or injury that would affect cognitive function.
About this study
Official title: The Aerobic and Cognitive Training System to Improve Cognition
This study will determine the effects of simultaneous exercise and cognitive training on cognitive function in healthy older adults. Specifically, this study will compare the use of a tablet-based cognitive training system while exercising with exercise alone, cognitive training alone, and a neutral control condition on cognition.
- Conditions
- Healthy Aging
- Being tested
- Simultaneous exercise and cognitive training, Exercise training, Cognitive Training, Neutral video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous exercise and cognitive trainingBehavioural
Participants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week.
Exercise trainingBehavioural
Participants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week.
Cognitive TrainingBehavioural
Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week.
Neutral videoBehavioural
Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous exercise and cognitive training | Experimental | Participants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week. Receives: Behavioral: Simultaneous exercise and cognitive training |
| Exercise training | Active comparator | Participants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week. Receives: Behavioral: Exercise training |
| Cognitive training | Active comparator | Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week. Receives: Behavioral: Cognitive Training |
| Neutral Video | Active comparator | Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week. Receives: Behavioral: Neutral video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cognitive function during dual-task test at 12 weeks
Performance on serial subtraction during dual-task walking.
Measured: Baseline and 12-weeks
Secondary outcomes (7)
Change from baseline in stride length during dual-task test
The difference between stride length in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks
Measured: Baseline, 6 weeks, 12 weeks
Change from baseline in stride duration during dual-task test
The difference between stride duration in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks
Measured: Baseline, 6 weeks, 12 weeks
Change from baseline in stride velocity during dual-task test
The difference between stride velocity in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks
Measured: Baseline, 6 weeks, 12 weeks
Change from baseline in stride length variability during dual-task test
The difference between stride length variability (measured by coefficient of variation) in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks
Measured: Baseline, 6 weeks, 12 weeks
Change from baseline in stride duration variability during dual-task test
The difference between stride duration variability (measured by coefficient of variation) in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks
Measured: Baseline, 6 weeks, 12 weeks
Change from baseline in stride velocity variability during dual-task test
The difference between stride velocity variability (measured by coefficient of variation) in single and dual-task walking will be assessed at baseline, 6 weeks, and 12 weeks
Measured: Baseline, 6 weeks, 12 weeks
Change from baseline in cognitive function during dual-task test at 6 weeks
Performance on serial subtraction during dual-task walking.
Measured: Baseline and 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 May 2015
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gene Alexander, Principal investigator, University of ArizonaDavid Raichlen, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120792
- Sponsor's protocol ID
- UA15-011
- Status last verified
- May 2019
- First submitted
- 4 Oct 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
Publications
Raichlen DA, Bharadwaj PK, Nguyen LA, Franchetti MK, Zigman EK, Solorio AR, Alexander GE. Effects of simultaneous cognitive and aerobic exercise training on dual-task walking performance in healthy older adults: results from a pilot randomized controlled trial. BMC Geriatr. 2020 Mar 2;20(1):83. doi: 10.1186/s12877-020-1484-5.
PubMed 32122325
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Aerobic and Cognitive Training System to Improve Cognition
- ClinicalTrials.gov ID
- NCT04120792
- Acronym / sponsor ID
- UA15-011
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 9 Oct 2019 (actual)
- 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.
This study will determine the effects of simultaneous exercise and cognitive training on cognitive function in healthy older adults. Specifically, this study will compare the use of a tablet-based cognitive training system while exercising with exercise alone, cognitive training alone, and a neutral control condition on cognition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Simultaneous exercise and cognitive training | Experimental | Behavioral: Simultaneous exercise and cognitive trainingParticipants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week. |
| Exercise training | Active comparator | Behavioral: Exercise trainingParticipants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week. |
| Cognitive training | Active comparator | Behavioral: Cognitive TrainingParticipants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week. |
| Neutral Video | Active comparator | Behavioral: Neutral videoParticipants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week. |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generally healthy, age 60-74, and a written statement from their primary care physician indicating that they are able to participate in the 12-week exercise program.
Key exclusion criteria (1 listed)
- Subjects will be excluded from participating in the study if they express significant concerns about their memory or declines in other cognitive abilities, if they are not English speaking, or if they have histories of significant major neurological, psychiatric, or medical disorder or injury that would affect cognitive function.
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 |
|---|---|---|
| Simultaneous exercise and cognitive trainingParticipants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week. | Behavioural | Simultaneous exercise and cognitive training |
| Exercise trainingParticipants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week. | Behavioural | Exercise training |
| Cognitive TrainingParticipants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week. | Behavioural | Cognitive training |
| Neutral videoParticipants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week. | Behavioural | Neutral Video |
Primary outcome
Change from baseline in cognitive function during dual-task test at 12 weeks
Time frame: Baseline and 12-weeks
Performance on serial subtraction during dual-task walking.
7 secondary outcomes
Change from baseline in stride length during dual-task test
Time frame: Baseline, 6 weeks, 12 weeks
Change from baseline in stride duration during dual-task test
Time frame: Baseline, 6 weeks, 12 weeks
Change from baseline in stride velocity during dual-task test
Time frame: Baseline, 6 weeks, 12 weeks
Change from baseline in stride length variability during dual-task test
Time frame: Baseline, 6 weeks, 12 weeks
Change from baseline in stride duration variability during dual-task test
Time frame: Baseline, 6 weeks, 12 weeks
Change from baseline in stride velocity variability during dual-task test
Time frame: Baseline, 6 weeks, 12 weeks
Change from baseline in cognitive function during dual-task test at 6 weeks
Time frame: Baseline and 6-weeks
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 9 Oct 2019.
- Derived from this study: PubMed 32122325Raichlen DA, Bharadwaj PK, Nguyen LA, Franchetti MK, Zigman EK, Solorio AR, Alexander GE. Effects of simultaneous cognitive and aerobic exercise training on dual-task walking performance in healthy older adults: results from a pilot randomized controlled trial. BMC Geriatr. 2020 Mar 2;20(1):83. doi: 10.1186/s12877-020-1484-5.
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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.
Gene Alexander principal investigator
University of Arizona
David Raichlen principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous exercise and cognitive training, Exercise training and Cognitive Training in people with Healthy Aging, run by University of Arizona.
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 1 inclusion and 1 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 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in cognitive function during dual-task test at 12 weeks (time frame: Baseline and 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 NCT04120792, 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 9 Oct 2019.