Healthy AgingAATNCT06270862
A Digital Active Aging Training Program for Older Adults
A study testing Resilience training, cognitive training and physical exercise in people with Healthy Aging and Cognitive Change, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Cognitive Change, Psychological Stress
- What is being tested?
- Resilience training, cognitive training and physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2024to 31 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Study 1(Chinese group):
- Aged 65 or over and healthy
- Chinese migrant (e.g., Canadian citizens, immigrants, visitors that are born and raised in the Chinese culture)
- Can speak, read and write Mandarin
- Having access to a computer that has internet and allows Zoom meeting attendance
- Study 2(Canadian group):
Show all 10Show fewer
- Aged 65 or over and healthy
- White Canadian citizen
- Can speak, read and write English
- Having access to a computer that has internet and allows Zoom meeting attendance
Who cannot join
- Scored 10 or above on the Short blessed test (SBT)
- Unfit for light physical exercises
- Without access to a computer and internet
- With current or previous mental health diagnosis
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Cognitive Aging Lab
Toronto, Ontario, M5B 2K3
Lixia Yang, PhD, 416-979-5000 ext. 556522, lixiay@torontomu.ca
Lixia Yang, PhD
About this study
The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2).
The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom.
In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics.
Read the detailed description
Objectives:
- to develop a multi-domain digital active aging training program through Zoom to promote active aging; and
- to evaluate whether adding a resilience-building module would enhance the active aging training efficacy to mitigate the lingering detrimental impacts of the pandemic
Sample:
For Study 1, the investigators will recruit 120 Mandarin-speaking healthy older Chinese immigrants (aged 60+, Chinese migrants) through WeChat(a popular instant messaging app among Chinese)/email/lab website social media channels (e.g., Facebook, Twitter) from the community partners (see a list attached). For Study 2, we will recruit 120 English-speaking healthy White Canadian older adults (aged 60+) through TMSPSS (the senior participant pool at Toronto Metropolitan University) or advertisements.
Overall Design and Procedure:
Informed consent will be collected. The proposed study will take a traditional pretest-intervention-posttest design including three phases of research activities. In Phase 1 (pretest), the investigators will administer a large battery of outcome measures including physical, psychological (emotional and cognitive), and social function measures to assess the baseline performance. The data collected at pretest also addresses the first sub-objective to identify sociodemographic risk predictors for the biopsychosocial functions and resilience among Chinese older immigrants in Canada. In Phase 2 (intervention), participants will be randomly assigned to an "active aging with resilience", an "active aging", and a "workshop" control condition. They will go through 4 weeks of 8 sessions of training/control treatment delivered virtually through Zoom/YouTube and 8 sessions of offline self-practice. In Phase 3 (posttest), all participants who completed the intervention programs will complete the same battery of the outcome measures as administered at the pretest session. Their performance on the outcome measures at posttest will be compared against pretest to evaluate the efficacy of the training programs.
Intervention:
The virtually-delivered intervention program will be developed based on previous studies and practices that proved to be effective in resilience-building and active.
During the 4-week training period delivered through Zoom/YouTube, participants in the "active aging with resilience" group will complete 8 sessions (approximately 1.5 hours per session and 2 sessions per week) of active aging training program integrated with a resilience-building module. Each session will start with a 15-min session of resilience building activities modified from positive psychology resilience-building activities that promotes various resilience characters (e.g., gratitude, forgiveness, grit etc.). This will be followed by the 1-hour multi-dimensional active aging training activities, including progressive "aging in motion" physical and nutrition training (e.g., age-appropriate "Choose to move" physical workout on-line videos), cognitive training with executive function and speed based on a customized module on CogniFit website, socialization and social engagement (e.g., discussion on the topic and session, followed by homework on volunteering, calling friends/families, community activity participation etc.), and combined bio-psycho-social multi-component training (e.g., performing a cognitive tasks such as counting backwards or memorizing names while doing physical exercise in a virtual socialization setting). Participants in the "active aging" group will receive the same training except that the initial 15-min resilience-building activities will be replaced by warmup activities such as watching some pre-selected video on active aging and completing a quiz afterwards. Both the "active aging with resilience" and traditional "active aging" group will also engage in 8 offline practice sessions where they follow instructions to practice and repeat the last completed modules. Finally, participants in the receptive "workshop" control group will attend 8 virtual workshops or watching workshop videos (following the same 4-week schedule as the two training groups) on different aging-related topics such as physical health, mental health, cognitive wellbeing, emotional regulation, social engagement, and resilience. Each workshop will take approximately 1.5 hours (including 30 min for questions). They will also review and watch the replays of last workshops and take a short survey question after each review session. All these activities will be delivered virtually via Zoom/YouTube in groups of 10-15 individuals.
Data Analysis Plan To identify active aging and resilience predictors, a set of explorative multivariate linear regression models will be conducted on the data collected at the pretest session, with all sociodemographic as predictors and outcome measure performance as dependent variables. To evaluate the relative efficacy of the active aging intervention programs, a 3 (condition) by 2 (session) mixed model analysis of variances (ANOVA) models will be conducted on each outcome variable, after controlling for potential sociodemographic covariates. For comparison and clarity purposes, if the outcome measures within each function domain demonstrates similar patterns, the investigators will calculate a composite outcome variable based on the z-scores of all involved measures to index the performance level of that specific functional domain. This composite score will be used as the outcome variable in the ANOVA. In light of the literature, the investigators hypothesized that the "active aging with resilience" training will produce larger and wider benefits relative to the "active aging" training, both compared against the receptive "workshop" control condition.
- Being tested
- Resilience training, cognitive training, physical exercise, social interaction, workshop series
- Keywords
- Older adults, Active aging, Digital intervention, Resilience
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience trainingBehavioural
Receive mini course on what is resilience and how to use different exercises to be more resilient in life.
cognitive trainingBehavioural
Play games that trains attention, memory and planning using the services provided by CogniFit.
physical exerciseBehavioural
Engage in age-appropriate physical exercises.
social interactionBehavioural
Engage in social discussion with peers in the group.
workshop seriesBehavioural
Watch a series of workshops targeting the older adult population.
| Study group | Role | What they receive |
|---|---|---|
| Active aging with resilience (AR) | Experimental | In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 15-min resilience-building module. Receives: Behavioral: Resilience training; Behavioral: cognitive training; Behavioral: physical exercise; Behavioral: social interaction |
| Active aging without resilience (AA) | Active comparator | The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module, which will be replaced by watching 15 minutes of educational video on topics such as health, nature or travel. Receives: Behavioral: cognitive training; Behavioral: physical exercise; Behavioral: social interaction |
| Workshop training (WT) | Placebo comparator | The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics. Receives: Behavioral: workshop series |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Self-efficacy level (ESES)
(out of 40) higher score means better self-efficacy at carrying out regular physical activities and exercise.
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
the 5-item World Health Organization WellBeing Index (WHO-5)
(out of 25) higher score indicates better overall self-perception of wellbeing in the past 2 weeks
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Kessler Psychological Distress Scale (K10)
(out of 50) higher score indicates worse overall mental health
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Multidimensional Scale of Perceived Social Support (MSPSS)
(out of 7) higher score indicates higher levels of self-precepted social support
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Conner-Davidson Resilience Scale 10-item (CD RISC-10)
(out of 40) higher score indicates higher resilience in face of difficulty in life.
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Emotional regulation Questionnaire (ERQ)
Cognitive reappraisal (out of 42) and expressive suppression (out of 28). Higher score indicates higher inclination to use this facet to control their emotions.
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Positive and Negative Affect Schedule (PANAS)
Positive affect (out of 50) and negative affect (out of 50). Higher score indicates feelings of higher levels of the positive/negative affect at the moment.
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Visual working memory test
Assessed using computerized games from CogniFit. Higher score indicates better visual short-term memory and memory span.
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Divided attention test
Assessed using computerized games from CogniFit. Higher score indicates better ability to divide attention between two competing tasks.
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Visual memory test
Assessed using computerized games from CogniFit. Higher score indicates better ability to memorize and recognize shapes and sequence order of visual object.
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Stroop test
Assessed using computerized games from CogniFit. Higher score indicates better ability to inhibit irrelevant information in tasks.
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Sustained attention to response test
Assessed using computerized games from CogniFit. Higher score indicates better ability to sustain attention to show rapid response to targets when present.
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Secondary outcomes (4)
Satisfaction with life scale (SWLS)
(out of 35) higher score indicates higher self-perception of life satisfaction
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Instrumental Activities of Daily Living(IADL)
(out of 8) higher score indicates better ability to carry out daily physical activity
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
The 6-item De Jong Gierveld Loneliness Scale
(out of 30) higher score indicates higher levels of loneliness
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
The Brief Approach/Avoidance Coping Questionnaire (BACQ)
approach (out of 30) and avoidance (out of 30) scores. Higher score in each category indicates their inclination to act in relation to problems and illness.
Measured: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start8 Apr 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada, Age-Well NCE Inc., Cogniciti, Cognifit, Aging in Cloud
- Responsible party
- Principal investigator, Lixia Yang, Toronto Metropolitan University
- Investigators
- Lixia Yang, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270862
- Sponsor's protocol ID
- SSHRC-PEG2023-AAT
- Acronym
- AAT
- Status last verified
- Apr 2024
- First submitted
- 1 Jan 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Armitage R, Nellums LB. COVID-19 and the consequences of isolating the elderly. Lancet Public Health. 2020 May;5(5):e256. doi: 10.1016/S2468-2667(20)30061-X. Epub 2020 Mar 20. No abstract available.
PubMed 32199471Carstensen LL, Shavit YZ, Barnes JT. Age Advantages in Emotional Experience Persist Even Under Threat From the COVID-19 Pandemic. Psychol Sci. 2020 Nov;31(11):1374-1385. doi: 10.1177/0956797620967261. Epub 2020 Oct 26.
PubMed 33104409Bandura, A. (2006). Guide for constructing self-efficacy scales. In: Urdan T, Pajares F (eds.) Self-Efficacy Beliefs of Adolescents. New York, NY, USA: Information Age Publishing.
Chappell, N. L. & Havens, B. (1980). Old and Female: Testing the Double Jeopardy Hypothesis. The Sociological Quarterly, 21(2), 157-171,
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PubMed 16367493Dong X. Elder abuse in Chinese populations: a global review. J Elder Abuse Negl. 2015;27(3):196-232. doi: 10.1080/08946566.2015.1039154. Epub 2015 Apr 15.
PubMed 25874889Finset, A., Steine, S., Haugli, L., Steen, E., Laerum, E. (2002). The brief approach/avoidance coping questionnaire: Development and validation. Psychology, health & medicine, 7(1):75-85
Galea S, Merchant RM, Lurie N. The Mental Health Consequences of COVID-19 and Physical Distancing: The Need for Prevention and Early Intervention. JAMA Intern Med. 2020 Jun 1;180(6):817-818. doi: 10.1001/jamainternmed.2020.1562. No abstract available.
PubMed 32275292Gao, Z. (2021). Unsettled Belongings: Chinese immigrants' mental health nulnerability as a symptom of international politics in the COVID-19 pandemic. Journal of Humanistic Psychology, 61(2), 198-218. https://doi.org/10.1177/0022167820980620
De Jong Gierveld, J., & Van Tilburg, T. (2006). A 6-Item Scale for Overall, Emotional, and Social Loneliness: Confirmatory Tests on Survey Data. Research on Aging, 28(5), 582-598. https://doi.org/10.1177/0164027506289723
Kanning, M., Schlicht, W. (2008). A bio-psycho-social model of successful aging as shown through the variable "physical activity". European Review of Aging and Physical Activity, 5, 79-87. https://doi.org/10.1007/s11556-008-0035-4
Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.
PubMed 12214795Lai DW, Surood S. Chinese health beliefs of older Chinese in Canada. J Aging Health. 2009 Feb;21(1):38-62. doi: 10.1177/0898264308328636.
PubMed 19144968Lai, D. W. L., Daoust G., Li, L. (2014). Understanding elder abuse and neglect in aging Chinese immigrants in Canada. The Journal of Adult Protection, 16(5):322-34. DOI:10.1108/JAP-03-2014-0006
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PubMed 5349366
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Active Aging Training Program for Older Adults
- ClinicalTrials.gov ID
- NCT06270862
- Acronym / sponsor ID
- AAT / SSHRC-PEG2023-AAT
- Keywords
- Older adults, Active aging, Digital intervention, Resilience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada, Age-Well NCE Inc., Cogniciti, Cognifit, Aging in Cloud
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 2024 (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.
The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2).
The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom.
In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics.
Detailed description
Objectives:
- to develop a multi-domain digital active aging training program through Zoom to promote active aging; and
- to evaluate whether adding a resilience-building module would enhance the active aging training efficacy to mitigate the lingering detrimental impacts of the pandemic
Sample:
For Study 1, the investigators will recruit 120 Mandarin-speaking healthy older Chinese immigrants (aged 60+, Chinese migrants) through WeChat(a popular instant messaging app among Chinese)/email/lab website social media channels (e.g., Facebook, Twitter) from the community partners (see a list attached). For Study 2, we will recruit 120 English-speaking healthy White Canadian older adults (aged 60+) through TMSPSS (the senior participant pool at Toronto Metropolitan University) or advertisements.
Overall Design and Procedure:
Informed consent will be collected. The proposed study will take a traditional pretest-intervention-posttest design including three phases of research activities. In Phase 1 (pretest), the investigators will administer a large battery of outcome measures including physical, psychological (emotional and cognitive), and social function measures to assess the baseline performance. The data collected at pretest also addresses the first sub-objective to identify sociodemographic risk predictors for the biopsychosocial functions and resilience among Chinese older immigrants in Canada. In Phase 2 (intervention), participants will be randomly assigned to an "active aging with resilience", an "active aging", and a "workshop" control condition. They will go through 4 weeks of 8 sessions of training/control treatment delivered virtually through Zoom/YouTube and 8 sessions of offline self-practice. In Phase 3 (posttest), all participants who completed the intervention programs will complete the same battery of the outcome measures as administered at the pretest session. Their performance on the outcome measures at posttest will be compared against pretest to evaluate the efficacy of the training programs.
Intervention:
The virtually-delivered intervention program will be developed based on previous studies and practices that proved to be effective in resilience-building and active.
During the 4-week training period delivered through Zoom/YouTube, participants in the "active aging with resilience" group will complete 8 sessions (approximately 1.5 hours per session and 2 sessions per week) of active aging training program integrated with a resilience-building module. Each session will start with a 15-min session of resilience building activities modified from positive psychology resilience-building activities that promotes various resilience characters (e.g., gratitude, forgiveness, grit etc.). This will be followed by the 1-hour multi-dimensional active aging training activities, including progressive "aging in motion" physical and nutrition training (e.g., age-appropriate "Choose to move" physical workout on-line videos), cognitive training with executive function and speed based on a customized module on CogniFit website, socialization and social engagement (e.g., discussion on the topic and session, followed by homework on volunteering, calling friends/families, community activity participation etc.), and combined bio-psycho-social multi-component training (e.g., performing a cognitive tasks such as counting backwards or memorizing names while doing physical exercise in a virtual socialization setting). Participants in the "active aging" group will receive the same training except that the initial 15-min resilience-building activities will be replaced by warmup activities such as watching some pre-selected video on active aging and completing a quiz afterwards. Both the "active aging with resilience" and traditional "active aging" group will also engage in 8 offline practice sessions where they follow instructions to practice and repeat the last completed modules. Finally, participants in the receptive "workshop" control group will attend 8 virtual workshops or watching workshop videos (following the same 4-week schedule as the two training groups) on different aging-related topics such as physical health, mental health, cognitive wellbeing, emotional regulation, social engagement, and resilience. Each workshop will take approximately 1.5 hours (including 30 min for questions). They will also review and watch the replays of last workshops and take a short survey question after each review session. All these activities will be delivered virtually via Zoom/YouTube in groups of 10-15 individuals.
Data Analysis Plan To identify active aging and resilience predictors, a set of explorative multivariate linear regression models will be conducted on the data collected at the pretest session, with all sociodemographic as predictors and outcome measure performance as dependent variables. To evaluate the relative efficacy of the active aging intervention programs, a 3 (condition) by 2 (session) mixed model analysis of variances (ANOVA) models will be conducted on each outcome variable, after controlling for potential sociodemographic covariates. For comparison and clarity purposes, if the outcome measures within each function domain demonstrates similar patterns, the investigators will calculate a composite outcome variable based on the z-scores of all involved measures to index the performance level of that specific functional domain. This composite score will be used as the outcome variable in the ANOVA. In light of the literature, the investigators hypothesized that the "active aging with resilience" training will produce larger and wider benefits relative to the "active aging" training, both compared against the receptive "workshop" control condition.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active aging with resilience (AR) | Experimental | Behavioral: Resilience training, Behavioral: cognitive training, Behavioral: physical exercise, Behavioral: social interactionIn the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 15-min resilience-building module. |
| Active aging without resilience (AA) | Active comparator | Behavioral: cognitive training, Behavioral: physical exercise, Behavioral: social interactionThe traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module, which will be replaced by watching 15 minutes of educational video on topics such as health, nature or travel. |
| Workshop training (WT) | Placebo comparator | Behavioral: workshop seriesThe "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Aged 65 or over and healthy
- Chinese migrant (e.g., Canadian citizens, immigrants, visitors that are born and raised in the Chinese culture)
- Can speak, read and write Mandarin
- Having access to a computer that has internet and allows Zoom meeting attendance
- Aged 65 or over and healthy
Key exclusion criteria (4 listed)
- Scored 10 or above on the Short blessed test (SBT)
- Unfit for light physical exercises
- Without access to a computer and internet
- With current or previous mental health diagnosis
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 |
|---|---|---|
| Resilience trainingReceive mini course on what is resilience and how to use different exercises to be more resilient in life. | Behavioural | Active aging with resilience (AR) |
| cognitive trainingPlay games that trains attention, memory and planning using the services provided by CogniFit. | Behavioural | Active aging with resilience (AR), Active aging without resilience (AA) |
| physical exerciseEngage in age-appropriate physical exercises. | Behavioural | Active aging with resilience (AR), Active aging without resilience (AA) |
| social interactionEngage in social discussion with peers in the group. | Behavioural | Active aging with resilience (AR), Active aging without resilience (AA) |
| workshop seriesWatch a series of workshops targeting the older adult population. | Behavioural | Workshop training (WT) |
Primary outcome
Exercise Self-efficacy level (ESES)
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
(out of 40) higher score means better self-efficacy at carrying out regular physical activities and exercise.
the 5-item World Health Organization WellBeing Index (WHO-5)
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
(out of 25) higher score indicates better overall self-perception of wellbeing in the past 2 weeks
Kessler Psychological Distress Scale (K10)
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
(out of 50) higher score indicates worse overall mental health
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
(out of 7) higher score indicates higher levels of self-precepted social support
Conner-Davidson Resilience Scale 10-item (CD RISC-10)
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
(out of 40) higher score indicates higher resilience in face of difficulty in life.
Emotional regulation Questionnaire (ERQ)
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Cognitive reappraisal (out of 42) and expressive suppression (out of 28). Higher score indicates higher inclination to use this facet to control their emotions.
Positive and Negative Affect Schedule (PANAS)
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Positive affect (out of 50) and negative affect (out of 50). Higher score indicates feelings of higher levels of the positive/negative affect at the moment.
Visual working memory test
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Assessed using computerized games from CogniFit. Higher score indicates better visual short-term memory and memory span.
Divided attention test
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Assessed using computerized games from CogniFit. Higher score indicates better ability to divide attention between two competing tasks.
Visual memory test
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Assessed using computerized games from CogniFit. Higher score indicates better ability to memorize and recognize shapes and sequence order of visual object.
Stroop test
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Assessed using computerized games from CogniFit. Higher score indicates better ability to inhibit irrelevant information in tasks.
Sustained attention to response test
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Assessed using computerized games from CogniFit. Higher score indicates better ability to sustain attention to show rapid response to targets when present.
4 secondary outcomes
Satisfaction with life scale (SWLS)
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Instrumental Activities of Daily Living(IADL)
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
The 6-item De Jong Gierveld Loneliness Scale
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
The Brief Approach/Avoidance Coping Questionnaire (BACQ)
Time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 32199471Armitage R, Nellums LB. COVID-19 and the consequences of isolating the elderly. Lancet Public Health. 2020 May;5(5):e256. doi: 10.1016/S2468-2667(20)30061-X. Epub 2020 Mar 20. No abstract available.
- Background: PubMed 33104409Carstensen LL, Shavit YZ, Barnes JT. Age Advantages in Emotional Experience Persist Even Under Threat From the COVID-19 Pandemic. Psychol Sci. 2020 Nov;31(11):1374-1385. doi: 10.1177/0956797620967261. Epub 2020 Oct 26.
- BackgroundBandura, A. (2006). Guide for constructing self-efficacy scales. In: Urdan T, Pajares F (eds.) Self-Efficacy Beliefs of Adolescents. New York, NY, USA: Information Age Publishing.
- BackgroundChappell, N. L. & Havens, B. (1980). Old and Female: Testing the Double Jeopardy Hypothesis. The Sociological Quarterly, 21(2), 157-171,
- Background: PubMed 16367493Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- Background: PubMed 25874889Dong X. Elder abuse in Chinese populations: a global review. J Elder Abuse Negl. 2015;27(3):196-232. doi: 10.1080/08946566.2015.1039154. Epub 2015 Apr 15.
- BackgroundFinset, A., Steine, S., Haugli, L., Steen, E., Laerum, E. (2002). The brief approach/avoidance coping questionnaire: Development and validation. Psychology, health & medicine, 7(1):75-85
- Background: PubMed 32275292Galea S, Merchant RM, Lurie N. The Mental Health Consequences of COVID-19 and Physical Distancing: The Need for Prevention and Early Intervention. JAMA Intern Med. 2020 Jun 1;180(6):817-818. doi: 10.1001/jamainternmed.2020.1562. No abstract available.
- BackgroundGao, Z. (2021). Unsettled Belongings: Chinese immigrants' mental health nulnerability as a symptom of international politics in the COVID-19 pandemic. Journal of Humanistic Psychology, 61(2), 198-218. https://doi.org/10.1177/0022167820980620
- BackgroundDe Jong Gierveld, J., & Van Tilburg, T. (2006). A 6-Item Scale for Overall, Emotional, and Social Loneliness: Confirmatory Tests on Survey Data. Research on Aging, 28(5), 582-598. https://doi.org/10.1177/0164027506289723
- BackgroundKanning, M., Schlicht, W. (2008). A bio-psycho-social model of successful aging as shown through the variable "physical activity". European Review of Aging and Physical Activity, 5, 79-87. https://doi.org/10.1007/s11556-008-0035-4
- Background: PubMed 12214795Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.
- Choose to Move at Home video modulesLink provided by the sponsor.
- 23 resilience building activities \& exercises for adults. Resilience \& Coping, Positive PsychologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Healthy Aging
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Not yet recruitingObservational study
China Healthy Aging and Fitness Longitudinal Study
Physical Fitness, Aging
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Active, not recruiting
Improving Medication Management in World Trade Center Responders
Polypharmacy
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.
Lixia Yang, PhD principal investigator
Toronto Metropolitan 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 Resilience training, cognitive training and physical exercise in people with Healthy Aging and Cognitive Change, run by Toronto Metropolitan University at 1 site in Canada.
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 10 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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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 Canada. 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 Lixia Yang, PhD (416-979-5000 ext. 556522, lixiay@torontomu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Self-efficacy level (ESES) (time frame: (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion). 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?
On the ClinicalTrials.gov record for NCT06270862, which also lists 36 linked publications.
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 1 May 2024.