LifestyleNCT04576624
Brain-Health Lifestyle Restructuring Intervention
A study testing Lifestyle Intervention and social activity in people with Lifestyle and Cognitive Decline, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
With population aging, the number of older persons with cognitive impairments increases. Literature support the effectiveness of a lifestyle approach to promote the health of persons with cognitive impairment, as well as a Lifestyle Redesign intervention to improve the general health and quality of life of frail older… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lifestyle, Cognitive Decline, Aging
- What is being tested?
- Lifestyle Intervention and social activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 31 Jul 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 55 years old and living in the community
- Reported cognitive declines.
Who cannot join
- Within normal cognition, determined by scoring more than 24 in the Taiwanese version of the Montreal Cognitive Assessment
- Having any medical, neurological, psychiatric conditions, and depression by scoring above 10 in the Brief Symptom Rating Scale
- Having severe visual, auditory, speech or physical problems that limit them to follow instructions.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University
Tainan, 701
Ling-Hui Chang, Ph.D, 88662353535 ext. 5907, lhchang@mail.ncku.edu.tw
About this study
Official title: A Brain-Health Lifestyle Restructuring Intervention for Older Adults With Mild Cognitive Decline : Feasibility, Effectiveness, and Experiences With the Intervention
With population aging, the number of older persons with cognitive impairments increases. Literature support the effectiveness of a lifestyle approach to promote the health of persons with cognitive impairment, as well as a Lifestyle Redesign intervention to improve the general health and quality of life of frail older adults. The investigators propose to combine a multi-modal cognitive intervention and lifestyle redesign approach to improve the cognitive health of older persons with cognitive impairments.
Read the detailed description
With population aging, the number of older persons in Taiwan with cognitive impairments increases. Recent years witnessed an expansion of governmental policies and services dedicated to improve long-term care. It is critical to develop an effective cognitive intervention that can prevent, delay, or slow down cognitive decline. Although literature support a multi-modal approach to preserve the cognitive capacity of older adults with cognitive impairments, there is inadequate attention to facilitate the integration of cognitively therapeutic activities to daily routines, nor to the establishment of a lifestyle that promote brain health. Therefore, the adherence to the intervention program was low after the program ended.
Literature support the effectiveness of a lifestyle approach to promote the health of and reduce medical cost for persons with chronic diseases, such as cardiovascular diseases and diabetes. Empirical evidence also supports the effectiveness of Lifestyle Redesign intervention to improve the general health and quality of life of frail older adults. The investigators propose to combine a multi-modal cognitive intervention and lifestyle redesign approach to improve the brain health of older persons with cognitive impairments. The goals of this project are thus three-folds:
- To develop a contextualized lifestyle restructuring intervention that facilitates the integration of cognition-promoting activities into daily routines and examine the feasibility of this intervention.
- To compare the effectiveness of a brain-health lifestyle restructuring intervention, social activity, and passive control in (1) general cognition, activity participation, activities of daily living function, and quality of life, and (2)physical function and cognitive function at the end of the intervention, 6 months after, and one year after.
- To qualitatively explore the experiences of the participants with the intervention, perceived effectiveness, and its contextual influences.
This is a three-year project using a combined pragmatic randomized controlled clinical trial and multiple case studies mixed-method research design. One hundred twenty-two older adults with cognitive impairments and residing in community will be recruited and randomly assigned to the groups of Lifestyle Intervention, Social Activities, and Passive Control. Subjects in the Lifestyle Intervention group will, in six months, receive sixteen group sessions and six individualized treatment sessions. Social Activities Group will receive twenty-two group sessions. Control group will receive patient education materials with each assessment. All participants will receive pre- and post-intervention, 6-month, and 12-month follow-up evaluations. Primary outcomes include cognitive function, activity participation, daily activity functions , and quality of life. Secondary outcomes include physical function, functional memory, working memory, complex attention, and processing speed.
Descriptive statistics, inferential statistics, factorial ANNOVA, and Generalized Estimating Equation will be used to evaluate and compare the effectiveness of the Lifestyle Restructuring Intervention. This study will also use multiple case studies to qualitatively understand the experiences of eight participants about their participation in the intervention, cognitive decline, and the contextual factors that affects their participation. Sequential interviews and participant observation will be used to do qualitative data collection.
- Conditions
- Lifestyle, Cognitive Decline, Aging
- Being tested
- Lifestyle Intervention, social activity
- Keywords
- lifestyle intervention, brain health, aging, 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.
Lifestyle InterventionBehavioural
A combined approach of a lifestyle structuring intervention to improve the general health and quality of life of persons with cognitive impairments. The investigators propose to combine a multi-modal cognitive intervention and lifestyle redesign approach to improve the cognitive health of older persons with cognitive impairments.
social activityBehavioural
24 social gathering events
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | Subjects in the Lifestyle Intervention group will, in six months, receive sixteen group sessions and six individualized treatment sessions. Receives: Behavioral: Lifestyle Intervention |
| Social Activities | Sham comparator | Social Activities Group will receive twenty-two group sessions Receives: Behavioral: social activity |
| Passive Control | No intervention | Control group will receive patient education materials with each assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Measured: pre-intervention
Cognitive function
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Measured: 6 months after the intervention begins
Cognitive function
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Measured: 6 month after the end of intervention
Activity participation
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
Measured: pre-intervention
Activity participation
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
Measured: 6 months after the intervention begins
Change of activity participation
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
Measured: 6 month after the end of intervention
QOL (Quality of Life)
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
Measured: pre-intervention
QOL (Quality of Life)
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
Measured: 6 months after the intervention begins
QOL (Quality of Life)
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
Measured: 6 month after the end of intervention
Secondary outcomes (15)
Physical function
Short Physical Performance Battery
Measured: pre-intervention
Physical function
Short Physical Performance Battery has a scale of 0-12, higher score indicating a better outcome.
Measured: 6 months after the intervention begins
Physical function
Short Physical Performance Battery has a scale of 0-12, higher score indicating a better outcome.
Measured: 6 month after the end of intervention
Functional memory
Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
Measured: pre-intervention
Functional memory
Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
Measured: 6 months after the intervention begins
Functional memory
Contextual Memory Test with a score of 0-20, with higher score indicating a better outcome.
Measured: 6 months after the end of intervention
Working memory
Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
Measured: pre-intervention
Working memory
Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
Measured: 6 months after the intervention begins
Working memory
Digit Forward and Digit Backward with a score of 2-10, , with higher score indicating a better outcome.
Measured: 6 months after the end of intervention
Complex attention
The score of Color Trail Test-1 \& 2 is the time spent to complete the test. The test will be terminated when 4 minute is up. Lesser time indicates a better outcome.
Measured: pre-intervention
Complex attention
The score of Color Trail Test-1 \& 2 is the time spent to complete the test. The test will be terminated when 4 minute is up. Lesser time indicates a better outcome.
Measured: 6 months after the intervention begins
Complex attention
The score of Color Trail Test-1 \& 2 is the time spent to complete the test. The test will be terminated when 4 minute is up. Lesser time indicates a better outcome.
Measured: 6 months after the end of intervention
Processing speed
Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
Measured: pre-intervention
Processing speed
Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
Measured: 6 months after the intervention begins
Processing speed
Symbol Digit Substitution Test takes 90 seconds to complete. The score is the number of correct responses. A higher score indicates a better outcome.
Measured: 6 months after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Aug 2020
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LifestyleStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- three-year project using a combined pragmatic randomized controlled clinical trial and multiple case studies mixed-method research design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Ling-Hui Chang, National Cheng Kung University
- Investigators
- Ling-Hui Chang, Principal investigator, Department of Occupational Therapy, NCKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576624
- Sponsor's protocol ID
- National Cheng-Kung University
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brain-Health Lifestyle Restructuring Intervention for Older Adults With Mild Cognitive Decline : Feasibility, Effectiveness, and Experiences With the Intervention
- ClinicalTrials.gov ID
- NCT04576624
- Acronym / sponsor ID
- National Cheng-Kung University
- Conditions
- Lifestyle, Cognitive Decline, Aging
- Keywords
- lifestyle intervention, brain health, aging, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 6 Oct 2020 (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.
With population aging, the number of older persons with cognitive impairments increases. Literature support the effectiveness of a lifestyle approach to promote the health of persons with cognitive impairment, as well as a Lifestyle Redesign intervention to improve the general health and quality of life of frail older adults. The investigators propose to combine a multi-modal cognitive intervention and lifestyle redesign approach to improve the cognitive health of older persons with cognitive impairments.
Detailed description
With population aging, the number of older persons in Taiwan with cognitive impairments increases. Recent years witnessed an expansion of governmental policies and services dedicated to improve long-term care. It is critical to develop an effective cognitive intervention that can prevent, delay, or slow down cognitive decline. Although literature support a multi-modal approach to preserve the cognitive capacity of older adults with cognitive impairments, there is inadequate attention to facilitate the integration of cognitively therapeutic activities to daily routines, nor to the establishment of a lifestyle that promote brain health. Therefore, the adherence to the intervention program was low after the program ended.
Literature support the effectiveness of a lifestyle approach to promote the health of and reduce medical cost for persons with chronic diseases, such as cardiovascular diseases and diabetes. Empirical evidence also supports the effectiveness of Lifestyle Redesign intervention to improve the general health and quality of life of frail older adults. The investigators propose to combine a multi-modal cognitive intervention and lifestyle redesign approach to improve the brain health of older persons with cognitive impairments. The goals of this project are thus three-folds:
- To develop a contextualized lifestyle restructuring intervention that facilitates the integration of cognition-promoting activities into daily routines and examine the feasibility of this intervention.
- To compare the effectiveness of a brain-health lifestyle restructuring intervention, social activity, and passive control in (1) general cognition, activity participation, activities of daily living function, and quality of life, and (2)physical function and cognitive function at the end of the intervention, 6 months after, and one year after.
- To qualitatively explore the experiences of the participants with the intervention, perceived effectiveness, and its contextual influences.
This is a three-year project using a combined pragmatic randomized controlled clinical trial and multiple case studies mixed-method research design. One hundred twenty-two older adults with cognitive impairments and residing in community will be recruited and randomly assigned to the groups of Lifestyle Intervention, Social Activities, and Passive Control. Subjects in the Lifestyle Intervention group will, in six months, receive sixteen group sessions and six individualized treatment sessions. Social Activities Group will receive twenty-two group sessions. Control group will receive patient education materials with each assessment. All participants will receive pre- and post-intervention, 6-month, and 12-month follow-up evaluations. Primary outcomes include cognitive function, activity participation, daily activity functions , and quality of life. Secondary outcomes include physical function, functional memory, working memory, complex attention, and processing speed.
Descriptive statistics, inferential statistics, factorial ANNOVA, and Generalized Estimating Equation will be used to evaluate and compare the effectiveness of the Lifestyle Restructuring Intervention. This study will also use multiple case studies to qualitatively understand the experiences of eight participants about their participation in the intervention, cognitive decline, and the contextual factors that affects their participation. Sequential interviews and participant observation will be used to do qualitative data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- three-year project using a combined pragmatic randomized controlled clinical trial and multiple case studies mixed-method research design
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionSubjects in the Lifestyle Intervention group will, in six months, receive sixteen group sessions and six individualized treatment sessions. |
| Social Activities | Sham comparator | Behavioral: social activitySocial Activities Group will receive twenty-two group sessions |
| Passive Control | No intervention | –Control group will receive patient education materials with each assessment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 55 years old and living in the community
- Reported cognitive declines.
Key exclusion criteria (3 listed)
- Within normal cognition, determined by scoring more than 24 in the Taiwanese version of the Montreal Cognitive Assessment
- Having any medical, neurological, psychiatric conditions, and depression by scoring above 10 in the Brief Symptom Rating Scale
- Having severe visual, auditory, speech or physical problems that limit them to follow instructions.
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 |
|---|---|---|
| Lifestyle InterventionA combined approach of a lifestyle structuring intervention to improve the general health and quality of life of persons with cognitive impairments. The investigators propose to combine a multi-modal cognitive intervention and lifestyle redesign approach to improve the cognitive health of older persons with cognitive impairments. | Behavioural | Lifestyle Intervention |
| social activity24 social gathering events | Behavioural | Social Activities |
Primary outcome
Cognitive function
Time frame: pre-intervention
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Cognitive function
Time frame: 6 months after the intervention begins
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Cognitive function
Time frame: 6 month after the end of intervention
Montreal Cognitive Assessment, with a value of 0-30. Higher scores mean a better outcome.
Activity participation
Time frame: pre-intervention
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
Activity participation
Time frame: 6 months after the intervention begins
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
Change of activity participation
Time frame: 6 month after the end of intervention
Canadian Performance of Occupational Performance, with a value of 0-10. Higher scores mean a better outcome.
QOL (Quality of Life)
Time frame: pre-intervention
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
QOL (Quality of Life)
Time frame: 6 months after the intervention begins
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
QOL (Quality of Life)
Time frame: 6 month after the end of intervention
COOP/WONCA is the full title of the assessment. The assessment has a value of 6-30. Higher scores mean a poorer outcome.
15 secondary outcomes
Physical function
Time frame: pre-intervention
Physical function
Time frame: 6 months after the intervention begins
Physical function
Time frame: 6 month after the end of intervention
Functional memory
Time frame: pre-intervention
Functional memory
Time frame: 6 months after the intervention begins
Functional memory
Time frame: 6 months after the end of intervention
Working memory
Time frame: pre-intervention
Working memory
Time frame: 6 months after the intervention begins
Working memory
Time frame: 6 months after the end of intervention
Complex attention
Time frame: pre-intervention
Complex attention
Time frame: 6 months after the intervention begins
Complex attention
Time frame: 6 months after the end of intervention
Processing speed
Time frame: pre-intervention
Processing speed
Time frame: 6 months after the intervention begins
Processing speed
Time frame: 6 months after the end of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- 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.
Ling-Hui Chang principal investigator
Department of Occupational Therapy, NCKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention and social activity in people with Lifestyle and Cognitive Decline, run by National Cheng Kung University at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 6 Oct 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling Hui Chang, Ph.D (+886918214428, lhchang@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: pre-intervention). The study lists 9 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 6 Oct 2020.