Mild Cognitive ImpairmentNCT05318703
Virtual Exercise For Older Adults With Mild Cognitive Impairment
A study testing tai ji quan and Stretching in people with Mild Cognitive Impairment, run by Oregon Research Institute at 1 site in United States.
Trial summary
This project is designed to develop and evaluate an Internet-based exercise intervention (tai ji quan Moving to Improve Brain Health) using real-time videoconferencing for older adults with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- tai ji quan and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 30 Oct 2022
- 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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Self-report a change or decline in memory (corroborated by an informant)
- Record a score of ≤0.5 on the Clinical Dementia Rating (CDR) scale (with information derived from both the participant and an informant)
- Show no major impairment in cognitive function as indexed by a score of ≥24 on the Mini Mental State Evaluation (MMSE).
Who cannot join
- Have participated in a rigorous and structured physical activity or exercise program (including Tai Ji Quan) in the past 6 months,
- Show major signs of depression as indicated by a score of ≥5 on the Geriatric Depression Scale
- Have major medical or physical conditions that preclude exercise, as determined by their healthcare practitioner
- Being unable to follow the consent process or sign the study consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Exercise Intervention for Older Adults With MCI
This project is designed to develop and evaluate an Internet-based exercise intervention (tai ji quan Moving to Improve Brain Health) using real-time videoconferencing for older adults with mild cognitive impairment (MCI).
Read the detailed description
The project has three major goals: (a) transforming an in-person tai ji quan brain health intervention protocol into an online (virtual) class protocol and evaluating its feasibility of implementation in older adults with MCI, (b) developing and evaluating online assessment and data ascertainment procedures that encompass cognitive and physical performance measures, and (c) conducting a randomized controlled trial comparing the effectiveness of this new online intervention protocol with a conventional stretching exercise group in older adults with MCI.
- Conditions
- Mild Cognitive Impairment
- Being tested
- tai ji quan, Stretching
- Keywords
- tai chi, ehealth, older adults, cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tai ji quanBehavioural
cognitively enhanced tai ji quan exercise
StretchingBehavioural
Stretching exercise
| Study group | Role | What they receive |
|---|---|---|
| cognitively enhanced tai ji quan | Experimental | Participants receive a cognitively enhanced tai ji quan exercise intervention for 16 weeks. Receives: Behavioral: tai ji quan |
| stretching exercise | Active comparator | Participants receive a stretching exercise intervention for 16 weeks. Receives: Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
(a) Total number of intervention sessions taught by instructors over the course of study (recorded by a class check sheet) and (b) total number of classes attended by participants over the course of intervention as recorded by class attendance sheet
assess the extent to which interventionists successfully implement the prespecified exercise training protocol.
Measured: 16 weeks
number of dropouts from the intervention and study as assessed by a study recording sheet
assess intervention dropout rate and retention rate
Measured: 16 weeks
Number of participants expressing intervention program satisfaction as assessed by a self-report survey
assess the program acceptability among tai ji quan participants
Measured: 16 weeks
Change in global cognitive function assessed by Montreal Cognitive Assessment
assess change from baseline cognitive function at 16 weeks
Measured: baseline, 16 weeks
Change in attention and working memory as assessed by Digit Span - forward and backward
assess change from baseline in attention and working memory at 16 weeks
Measured: baseline, 16 weeks
Change in dual-task cost as assessed by Timed Up and Go with a cognitive task
assess change from baseline in the ability to stand up from a chair, walk, and sit down while performing an arithmetic task at 16 weeks
Measured: baseline, 16 weeks
Change in executive function as assessed by Trail Making B
assess change from baseline executive function at 16 weeks
Measured: baseline, 16 weeks
Change in executive function as assessed by Category Fluency for Animals
assess change from baseline executive function at 16 weeks
Measured: baseline, 16 weeks
Change in cognitive functioning assessed by Everyday Cognition
assess change from baseline cognitive functioning at 16 weeks
Measured: baseline, 16 weeks
Change in physical performance as measured by Timed Up and Go test
assess change from baseline in the ability to stand up from a chair, walk, and sit down at 16 weeks
Measured: baseline, 16 weeks
change in leg strength as assessed by 30-second chair stand test
assess change from baseline in leg strength at 16 weeks
Measured: baseline, 16 weeks
Change in balance using a 4-stage balance test
assess change from baseline in balance at 16 weeks
Measured: baseline, 16 weeks
Secondary outcomes (3)
Change in depression as assessed by Geriatric Depression scale
assess change from baseline in the level of depression at 16 weeks
Measured: baseline, 16 weeks
Change in physical activity as assessed by International Physical Activity Questionnaire
assess change from baseline in physical activity at 16 weeks
Measured: baseline, 16 weeks
Change in quality of life as assessed by EuroQol (EQ-5D-3L)
assess change from baseline in quality of life at 16 weeks
Measured: baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start20 Jan 2021
- Primary completion30 Aug 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuzhong Li, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318703
- Sponsor's protocol ID
- AG059546-02S1
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Exercise Intervention for Older Adults With MCI
- ClinicalTrials.gov ID
- NCT05318703
- Acronym / sponsor ID
- AG059546-02S1
- Conditions
- Mild Cognitive Impairment
- Keywords
- tai chi, ehealth, older adults, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 8 Apr 2022 (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 project is designed to develop and evaluate an Internet-based exercise intervention (tai ji quan Moving to Improve Brain Health) using real-time videoconferencing for older adults with mild cognitive impairment (MCI).
Detailed description
The project has three major goals: (a) transforming an in-person tai ji quan brain health intervention protocol into an online (virtual) class protocol and evaluating its feasibility of implementation in older adults with MCI, (b) developing and evaluating online assessment and data ascertainment procedures that encompass cognitive and physical performance measures, and (c) conducting a randomized controlled trial comparing the effectiveness of this new online intervention protocol with a conventional stretching exercise group in older adults with MCI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitively enhanced tai ji quan | Experimental | Behavioral: tai ji quanParticipants receive a cognitively enhanced tai ji quan exercise intervention for 16 weeks. |
| stretching exercise | Active comparator | Behavioral: StretchingParticipants receive a stretching exercise intervention for 16 weeks. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Self-report a change or decline in memory (corroborated by an informant)
- Record a score of ≤0.5 on the Clinical Dementia Rating (CDR) scale (with information derived from both the participant and an informant)
- Show no major impairment in cognitive function as indexed by a score of ≥24 on the Mini Mental State Evaluation (MMSE).
Key exclusion criteria (4 listed)
- Have participated in a rigorous and structured physical activity or exercise program (including Tai Ji Quan) in the past 6 months,
- Show major signs of depression as indicated by a score of ≥5 on the Geriatric Depression Scale
- Have major medical or physical conditions that preclude exercise, as determined by their healthcare practitioner
- Being unable to follow the consent process or sign the study consent form.
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 ji quancognitively enhanced tai ji quan exercise | Behavioural | cognitively enhanced tai ji quan |
| StretchingStretching exercise | Behavioural | stretching exercise |
Primary outcome
(a) Total number of intervention sessions taught by instructors over the course of study (recorded by a class check sheet) and (b) total number of classes attended by participants over the course of intervention as recorded by class attendance sheet
Time frame: 16 weeks
assess the extent to which interventionists successfully implement the prespecified exercise training protocol.
number of dropouts from the intervention and study as assessed by a study recording sheet
Time frame: 16 weeks
assess intervention dropout rate and retention rate
Number of participants expressing intervention program satisfaction as assessed by a self-report survey
Time frame: 16 weeks
assess the program acceptability among tai ji quan participants
Change in global cognitive function assessed by Montreal Cognitive Assessment
Time frame: baseline, 16 weeks
assess change from baseline cognitive function at 16 weeks
Change in attention and working memory as assessed by Digit Span - forward and backward
Time frame: baseline, 16 weeks
assess change from baseline in attention and working memory at 16 weeks
Change in dual-task cost as assessed by Timed Up and Go with a cognitive task
Time frame: baseline, 16 weeks
assess change from baseline in the ability to stand up from a chair, walk, and sit down while performing an arithmetic task at 16 weeks
Change in executive function as assessed by Trail Making B
Time frame: baseline, 16 weeks
assess change from baseline executive function at 16 weeks
Change in executive function as assessed by Category Fluency for Animals
Time frame: baseline, 16 weeks
assess change from baseline executive function at 16 weeks
Change in cognitive functioning assessed by Everyday Cognition
Time frame: baseline, 16 weeks
assess change from baseline cognitive functioning at 16 weeks
Change in physical performance as measured by Timed Up and Go test
Time frame: baseline, 16 weeks
assess change from baseline in the ability to stand up from a chair, walk, and sit down at 16 weeks
change in leg strength as assessed by 30-second chair stand test
Time frame: baseline, 16 weeks
assess change from baseline in leg strength at 16 weeks
Change in balance using a 4-stage balance test
Time frame: baseline, 16 weeks
assess change from baseline in balance at 16 weeks
3 secondary outcomes
Change in depression as assessed by Geriatric Depression scale
Time frame: baseline, 16 weeks
Change in physical activity as assessed by International Physical Activity Questionnaire
Time frame: baseline, 16 weeks
Change in quality of life as assessed by EuroQol (EQ-5D-3L)
Time frame: baseline, 16 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 22 Mar 2023.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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.
Fuzhong Li, Ph.D. principal investigator
Oregon Research Institute
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 ji quan and Stretching in people with Mild Cognitive Impairment, run by Oregon Research Institute 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 3 inclusion and 4 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 22 Mar 2023. 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?
(a) Total number of intervention sessions taught by instructors over the course of study (recorded by a class check sheet) and (b) total number of classes attended by participants over the course of intervention as recorded by class attendance sheet (time frame: 16 weeks). The study lists 12 primary outcomes in all. 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 22 Mar 2023.