NCT06270862

Brief 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). 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 8, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

January 1, 2024

Last Update Submit

April 29, 2024

Conditions

Keywords

Older adultsActive agingDigital interventionResilience

Outcome Measures

Primary Outcomes (12)

  • Exercise Self-efficacy level (ESES)

    (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)

    (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)

    (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)

    (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)

    (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)

    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)

    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

    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

    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

    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

    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

    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 Outcomes (4)

  • Satisfaction with life scale (SWLS)

    (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion

  • Instrumental Activities of Daily Living(IADL)

    (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

    (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)

    (1) pre-test (2) through study completion, an average of 1 month (3) 1-month post study completion

Study Arms (3)

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.

Behavioral: Resilience trainingBehavioral: cognitive trainingBehavioral: physical exerciseBehavioral: 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.

Behavioral: cognitive trainingBehavioral: physical exerciseBehavioral: 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.

Behavioral: workshop series

Interventions

Receive mini course on what is resilience and how to use different exercises to be more resilient in life.

Active aging with resilience (AR)

Play games that trains attention, memory and planning using the services provided by CogniFit.

Active aging with resilience (AR)Active aging without resilience (AA)

Engage in age-appropriate physical exercises.

Active aging with resilience (AR)Active aging without resilience (AA)

Engage in social discussion with peers in the group.

Active aging with resilience (AR)Active aging without resilience (AA)
workshop seriesBEHAVIORAL

Watch a series of workshops targeting the older adult population.

Workshop training (WT)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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):
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cognitive Aging Lab

Toronto, Ontario, M5B 2K3, Canada

RECRUITING

Related Publications (36)

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Related Links

MeSH Terms

Conditions

Stress, Psychological

Interventions

Cognitive TrainingExerciseDrug Interactions

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • Lixia Yang, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lixia Yang, PhD

CONTACT

Cassandra Skrotzki, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 1, 2024

First Posted

February 21, 2024

Study Start

April 8, 2024

Primary Completion

October 30, 2024

Study Completion

December 31, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations