- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06270862
A Digital Active Aging Training Program for Older Adults (AAT)
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lixia Yang, PhD
- Phone Number: 556522 416-979-5000
- Email: lixiay@torontomu.ca
Study Contact Backup
- Name: Cassandra Skrotzki, MA
- Phone Number: 554987 416-979-5000
- Email: cskrotzki@torontomu.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 2K3
- Recruiting
- Cognitive Aging Lab
-
Contact:
- Lixia Yang, PhD
- Phone Number: 556522 416-979-5000
- Email: lixiay@torontomu.ca
-
Principal Investigator:
- Lixia Yang, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Study 1(Chinese group):
- Aged 60 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):
- Aged 60 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
Exclusion Criteria:
- Scored 6 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active aging with resilience (AR)
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.
|
Receive mini course on what is resilience and how to use different exercises to be more resilient in life.
Play games that trains attention, memory and planning using the services provided by CogniFit.
Engage in age-appropriate physical exercises.
Engage in social discussion with peers in the group.
|
Active Comparator: Active aging without resilience (AA)
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.
|
Play games that trains attention, memory and planning using the services provided by CogniFit.
Engage in age-appropriate physical exercises.
Engage in social discussion with peers in the group.
|
Placebo Comparator: Workshop training (WT)
The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics.
|
Watch a series of workshops targeting the older adult population.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
(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)
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
|
(1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
|
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
|
(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)
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
|
(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)
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.
|
(1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
|
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.
|
(1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
|
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.
|
(1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
|
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.
|
(1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
|
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.
|
(1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
|
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.
|
(1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
|
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.
|
(1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
|
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.
|
(1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
(out of 35) higher score indicates higher self-perception of life satisfaction
|
(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
|
(out of 8) higher score indicates better ability to carry out daily physical activity
|
(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
|
(out of 30) higher score indicates higher levels of loneliness
|
(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
|
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.
|
(1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lixia Yang, PhD, Toronto Metropolitan University
Publications and helpful links
General Publications
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- Dong 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.
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- 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.
- Gao, 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
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- Mendoza-Ruvalcaba NM, Arias-Merino ED. "I am active": effects of a program to promote active aging. Clin Interv Aging. 2015 May 5;10:829-37. doi: 10.2147/CIA.S79511. eCollection 2015.
- Na L, Yang L, Mezo PG, Liu R. Age disparities in mental health during the COVID19 pandemic: The roles of resilience and coping. Soc Sci Med. 2022 Jul;305:115031. doi: 10.1016/j.socscimed.2022.115031. Epub 2022 May 13.
- Perez-Rojo G, Lopez J, Noriega C, Velasco C, Carretero I, Lopez-Frutos P, Galarraga L. A multidimensional approach to the resilience in older adults despite COVID-19. BMC Geriatr. 2022 Oct 11;22(1):793. doi: 10.1186/s12877-022-03472-y.
- Qian M, Wu Q, Wu P, Hou Z, Liang Y, Cowling BJ, Yu H. Anxiety levels, precautionary behaviours and public perceptions during the early phase of the COVID-19 outbreak in China: a population-based cross-sectional survey. BMJ Open. 2020 Oct 8;10(10):e040910. doi: 10.1136/bmjopen-2020-040910.
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- Yang L, Gallant SN, Wilkins LK, Dyson B. Cognitive and Psychosocial Outcomes of Self-Guided Executive Function Training and Low-Intensity Aerobic Exercise in Healthy Older Adults. Front Aging Neurosci. 2020 Nov 19;12:576744. doi: 10.3389/fnagi.2020.576744. eCollection 2020.
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- Yang L, Yu L, Kandasamy K, Wang Y, Shi F, Zhang W, Wang PP. Non-Pathological Psychological Distress among Mainland Chinese in Canada and Its Sociodemographic Risk Factors amidst the Pandemic. Healthcare (Basel). 2022 Nov 21;10(11):2326. doi: 10.3390/healthcare10112326.
- Yin J, Lassale C, Steptoe A, Cadar D. Exploring the bidirectional associations between loneliness and cognitive functioning over 10 years: the English longitudinal study of ageing. Int J Epidemiol. 2019 Dec 1;48(6):1937-1948. doi: 10.1093/ije/dyz085.
- Zhang W. Perceptions of elder abuse and neglect by older Chinese immigrants in Canada. J Elder Abuse Negl. 2019 Aug-Dec;31(4-5):340-362. doi: 10.1080/08946566.2019.1652718. Epub 2019 Aug 8.
- Zimet, G. D., Dahlem, N. W., Zimet, S. G., Farley, G. K. (1988). The Multidimensional Scale of Perceived Social Support. Journal of Personality Assessment, 52(1), 30-41. https://doi.org/10.1207/s15327752jpa5201_2
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSHRC-PEG2023-AAT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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