AgingNCT00979069
Aerobic Exercise to Improve Executive Language Function In Older Adults
A study testing Aerobic group in people with Aging, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The purpose of this study is to see if exercise can improve brain function in older adults Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Aerobic group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Jan 2012
- 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 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Consent of participants' primary health care physicians to participate in the aerobic exercise.
- Patients must not have participated in any consistent exercise program or experimental study for at least 3 months prior to enrollment.
- They must be capable of providing informed consent and complying with the trial procedures.
Who cannot join
- Demented as defined by the Modified Mini Mental Status Exam.
- Unalterable travel schedules.
- Site accessibility constraints.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
About this study
Official title: Aerobic Exercise to Improve Executive Language Function in Older Adults
The purpose of this study is to see if exercise can improve brain function in older adults
Read the detailed description
Recently, considerable attention has been devoted to examining the beneficial relationship between cognition and aerobic exercise in older adults. Specifically, the effects are thought to involve higher order cognitive processes, such as working memory, switching between tasks, and inhibiting irrelevant information, all of which are thought to be sub- served, in part, by the frontal lobes (Colcombe et al., 2006). Importantly, these areas also are most susceptible to age-related decline (Raz, 2000) and are essential resources for language production (Kemper \& Sumner, 2001; Murray \& Lenz, 2001). However, despite promising cognitive improvement, changes in frontally-mediated executive language functions have been widely ignored. This is unfortunate considering impaired word retrieval compromises communicative effectiveness, leading to frustration, depression, and withdrawal. Perhaps more importantly, communication ineffectiveness, particularly in the elderly, leads to difficulties interacting with health care professionals leading to further health care burdens. Since cognition, and specifically word retrieval difficulties, usually remain untreated, it is important to find treatment strategies for minimizing these deficits. Therefore, the short-term goal and the purpose of this proposal is to examine the potential of aerobic exercise to improve executive language function in older adults.
- Conditions
- Aging
- Being tested
- Aerobic group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic groupBehavioural
12 weeks of aerobic exercise 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Group | Experimental | 12 weeks of aerobic exercise 3 times a week Receives: Behavioral: Aerobic group |
| Control Group | No intervention | No contact control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Language Functions
The Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89 (Delis, et al., 2001; Delis, Kramer, Kaplan, \& Hodnack, 2004). The Verbal Fluency Test has three conditions, Letter Verbal Fluency, Category Verbal Fluency, and Switching Verbal Fluency. Each was randomized at pre- and post-12 week timeline and equated for difficulty. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds,the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds, and the Switching Verbal Fluency assesses the number of words while alternating between different categories participants can generate within 60 seconds. For each condition (letter, category, and switching) a total score representing the total number of correct
Measured: number of correct words at 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 posted17 Sep 2009 (estimated)
- Study startSep 2010
- Primary completionJan 2012
- Study completionJan 2012
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- 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
- NCT00979069
- Sponsor's protocol ID
- E6860-M
- Status last verified
- Nov 2014
- First submitted
- 15 Sep 2009
- Last updated
- 26 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nocera JR, McGregor KM, Hass CJ, Crosson B. Spin exercise improves semantic fluency in previously sedentary older adults. J Aging Phys Act. 2015 Jan;23(1):90-4. doi: 10.1123/japa.2013-0107. Epub 2014 Jan 14.
PubMed 24425525
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise to Improve Executive Language Function in Older Adults
- ClinicalTrials.gov ID
- NCT00979069
- Acronym / sponsor ID
- E6860-M
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Posted 6 Nov 2014
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 see if exercise can improve brain function in older adults
Detailed description
Recently, considerable attention has been devoted to examining the beneficial relationship between cognition and aerobic exercise in older adults. Specifically, the effects are thought to involve higher order cognitive processes, such as working memory, switching between tasks, and inhibiting irrelevant information, all of which are thought to be sub- served, in part, by the frontal lobes (Colcombe et al., 2006). Importantly, these areas also are most susceptible to age-related decline (Raz, 2000) and are essential resources for language production (Kemper \& Sumner, 2001; Murray \& Lenz, 2001). However, despite promising cognitive improvement, changes in frontally-mediated executive language functions have been widely ignored. This is unfortunate considering impaired word retrieval compromises communicative effectiveness, leading to frustration, depression, and withdrawal. Perhaps more importantly, communication ineffectiveness, particularly in the elderly, leads to difficulties interacting with health care professionals leading to further health care burdens. Since cognition, and specifically word retrieval difficulties, usually remain untreated, it is important to find treatment strategies for minimizing these deficits. Therefore, the short-term goal and the purpose of this proposal is to examine the potential of aerobic exercise to improve executive language function in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Group | Experimental | Behavioral: Aerobic group12 weeks of aerobic exercise 3 times a week |
| Control Group | No intervention | –No contact control |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Consent of participants' primary health care physicians to participate in the aerobic exercise.
- Patients must not have participated in any consistent exercise program or experimental study for at least 3 months prior to enrollment.
- They must be capable of providing informed consent and complying with the trial procedures.
Key exclusion criteria (3 listed)
- Demented as defined by the Modified Mini Mental Status Exam.
- Unalterable travel schedules.
- Site accessibility constraints.
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 group12 weeks of aerobic exercise 3 times a week | Behavioural | Aerobic Group |
Primary outcome
Executive Language Functions
Time frame: number of correct words at pre and post separated by 12 weeks
The Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89 (Delis, et al., 2001; Delis, Kramer, Kaplan, \& Hodnack, 2004). The Verbal Fluency Test has three conditions, Letter Verbal Fluency, Category Verbal Fluency, and Switching Verbal Fluency. Each was randomized at pre- and post-12 week timeline and equated for difficulty. Letter Verbal Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds,the Category Verbal Fluency assesses the number of words within particular categories participants can generate within 60 seconds, and the Switching Verbal Fluency assesses the number of words while alternating between different categories participants can generate within 60 seconds. For each condition (letter, category, and switching) a total score representing the total number of correct
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24425525Nocera JR, McGregor KM, Hass CJ, Crosson B. Spin exercise improves semantic fluency in previously sedentary older adults. J Aging Phys Act. 2015 Jan;23(1):90-4. doi: 10.1123/japa.2013-0107. Epub 2014 Jan 14.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic group in people with Aging, run by US Department of Veterans Affairs at 2 sites 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 3 inclusion and 3 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 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 6 Nov 2014). 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?
Executive Language Functions (time frame: number of correct words at 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 NCT00979069, 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 26 Nov 2014.