AgingACE-SeniorsNCT01094509
Activities for Cognitive Enhancement of Seniors
A study testing Tai Chi, Guided autobiography and Qigong in people with Aging, run by Stanford University at 1 site in United States.
Trial summary
Cognitive aging and cognitive decline are important public health concerns in an aging US population. The investigators will conduct a randomized controlled trail among healthy older adults to assess effects of several innovative activities on remediation of age-related cognitive decline. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Tai Chi, Guided autobiography and Qigong
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2013
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 70 years of age or older.
- No other household member already enrolled.
- In reasonably good health: no serious cognitive problem; free of any condition that would limit your ability to participate in Tai Chi classes (a moderate intensity exercise), in Qigong exercises, in a writing program, or in a seminar series.
- Not presently engaged in a regular exercise program; not presently engaged in Tai Chi Qigong or another form of Eastern exercise; and not a regular writer.
- Not now engaged in research to enhance cognitive skills.
- Willing to travel to Stanford for ACE-Seniors program classes. Planning to be in the area during most of the coming year;
- Willing to be assigned randomly (by chance) to one of the ACE-Senior activities.
Who cannot join
- Failure to meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Tai Chi and Guided Autobiography for Remediation of Age-related Cognitive Decline
Cognitive aging and cognitive decline are important public health concerns in an aging US population. The investigators will conduct a randomized controlled trail among healthy older adults to assess effects of several innovative activities on remediation of age-related cognitive decline.
Read the detailed description
ACE-Seniors is designed as a single-site trial of four randomly assigned interventions, Tai Chi exercise, autobiographical writing, both Tai Chi and autobiography (dual intervention), and general health education. Participants are relatively healthy adults aged 70 years or older, who are not regular practitioners of Tai Chi or regular writers. They are without medical or neurological disorders that would substantially limit the ability to participate in study interventions, without dementia or mild cognitive impairment, relatively sedentary, able to walk unassisted, and able to score 4 or better on the Short Physical Performance Battery. Interventions are administered over a 6 month period of time, with similar exposure times among the four groups. The prespecified primary endpoint is derived from a composite neuropsychological measure, based on three tests of executive function and three tests of episodic memory. The planned sample size is 96 (24 per group). Intention-to-treat analysis will include all eligible participants who complete baseline assessments.
- Conditions
- Aging
- Being tested
- Tai Chi, Guided autobiography, Qigong, Successful aging, Combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
Tai Chi classes and exercises
Guided autobiographyBehavioural
Autobiographical writing in class and at home
QigongBehavioural
Qigong classes and exercises (exploratory)
Successful agingBehavioural
Seminar series on the theme of successful aging
CombinationBehavioural
Combination of Tai Chi exercises and autobiographical writing
ComparisonBehavioural
No assigned behavioral activity (exploratory)
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | Tai Chi exercises Receives: Behavioral: Tai Chi |
| Guided autobiography | Experimental | Autobiographical writing during class sessions and at home Receives: Behavioral: Guided autobiography |
| Qigong | Experimental | Qigong exercises (exploratory, not part of the original protocol, added to gain experience with this intervention) Receives: Behavioral: Qigong |
| Successful aging | Active comparator | Seminars on the theme of successful aging Receives: Behavioral: Successful aging |
| Combination | Experimental | Combination of Tai Chi exercises and autobiographical writing Receives: Behavioral: Combination |
| Comparison | Placebo comparator | No assigned experimental activity (exploratory, not part of the original protocol, added to gain experience with a placebo comparator) Receives: Behavioral: Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive (executive function and episodic memory)
Measured: 6 and 12 months
Secondary outcomes (3)
Other cognitive measures
Measured: 6 and 12 months
Physical performance and other non-cognitive measures
Measured: 6 and 12 months
Adherence and retention
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Victor W. Henderson, Stanford University
- Investigators
- Dr Victor Henderson, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094509
- Sponsor's protocol ID
- SU-02042010-4903
- Other IDs
- R01AG034639
- Acronym
- ACE-Seniors
- Status last verified
- Nov 2014
- First submitted
- 25 Mar 2010
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi and Guided Autobiography for Remediation of Age-related Cognitive Decline
- ClinicalTrials.gov ID
- NCT01094509
- Acronym / sponsor ID
- ACE-Seniors / SU-02042010-4903
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Mar 2010 (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.
Cognitive aging and cognitive decline are important public health concerns in an aging US population. The investigators will conduct a randomized controlled trail among healthy older adults to assess effects of several innovative activities on remediation of age-related cognitive decline.
Detailed description
ACE-Seniors is designed as a single-site trial of four randomly assigned interventions, Tai Chi exercise, autobiographical writing, both Tai Chi and autobiography (dual intervention), and general health education. Participants are relatively healthy adults aged 70 years or older, who are not regular practitioners of Tai Chi or regular writers. They are without medical or neurological disorders that would substantially limit the ability to participate in study interventions, without dementia or mild cognitive impairment, relatively sedentary, able to walk unassisted, and able to score 4 or better on the Short Physical Performance Battery. Interventions are administered over a 6 month period of time, with similar exposure times among the four groups. The prespecified primary endpoint is derived from a composite neuropsychological measure, based on three tests of executive function and three tests of episodic memory. The planned sample size is 96 (24 per group). Intention-to-treat analysis will include all eligible participants who complete baseline assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai ChiTai Chi exercises |
| Guided autobiography | Experimental | Behavioral: Guided autobiographyAutobiographical writing during class sessions and at home |
| Qigong | Experimental | Behavioral: QigongQigong exercises (exploratory, not part of the original protocol, added to gain experience with this intervention) |
| Successful aging | Active comparator | Behavioral: Successful agingSeminars on the theme of successful aging |
| Combination | Experimental | Behavioral: CombinationCombination of Tai Chi exercises and autobiographical writing |
| Comparison | Placebo comparator | Behavioral: ComparisonNo assigned experimental activity (exploratory, not part of the original protocol, added to gain experience with a placebo comparator) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 70 years of age or older.
- No other household member already enrolled.
- In reasonably good health: no serious cognitive problem; free of any condition that would limit your ability to participate in Tai Chi classes (a moderate intensity exercise), in Qigong exercises, in a writing program, or in a seminar series.
- Not presently engaged in a regular exercise program; not presently engaged in Tai Chi Qigong or another form of Eastern exercise; and not a regular writer.
- Not now engaged in research to enhance cognitive skills.
Key exclusion criteria (1 listed)
- Failure to meet inclusion criteria.
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 |
|---|---|---|
| Tai ChiTai Chi classes and exercises | Behavioural | Tai Chi |
| Guided autobiographyAutobiographical writing in class and at home | Behavioural | Guided autobiography |
| QigongQigong classes and exercises (exploratory) | Behavioural | Qigong |
| Successful agingSeminar series on the theme of successful aging | Behavioural | Successful aging |
| CombinationCombination of Tai Chi exercises and autobiographical writing | Behavioural | Combination |
| ComparisonNo assigned behavioral activity (exploratory) | Behavioural | Comparison |
Primary outcome
Cognitive (executive function and episodic memory)
Time frame: 6 and 12 months
3 secondary outcomes
Other cognitive measures
Time frame: 6 and 12 months
Physical performance and other non-cognitive measures
Time frame: 6 and 12 months
Adherence and retention
Time frame: 6 and 12 months
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 20 Nov 2014.
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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.
Dr Victor Henderson principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi, Guided autobiography and Qigong in people with Aging, run by Stanford University 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 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 20 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 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. Some participants in this study may receive a placebo. 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 (executive function and episodic memory) (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2014.