- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06202482
Enhance Physical Activity and Intergenerational Relationship Via Connect Active Program (CAP): a Pilot Randomized Controlled Trial
September 12, 2024 updated by: TSE Mun Yee Mimi, The Hong Kong Polytechnic University
This study investigates how walking exercises and technology could enhance the quality of life in the older generation.
It has three objectives: 1) To examine the effectiveness of the Connect Active Program (CAP) in improving intergenerational relationships, psychological well-being, and physical fitness for older adults; 2) To teach older adults to use mobile apps; 3) To examine the experiences and feedback from participants in using the apps and joining the CAP.
This research will provide long-term insights into improving the overall health outcomes of older adults via intergenerational support and increasing the acceptance of mobile technology among older adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kowloon, Hong Kong
- Hong Kong Metropolitan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Younger Adults/Participants:
- Aged 18 to 30
- Related to the older adult participant (i.e. family member, relatives)
- Able to understand Cantonese
- Own a smartphone and have access to the Internet
- Able to take part in walking exercise and stretching program
Older Adults/Participants:
- Aged 60 or above
- Able to understand Cantonese
- Own a smartphone and have access to the Internet
- Capable to participate in walking exercise and stretching program
Exclusion Criteria:
Older Adults/Participants and Younger Adults/Participants:
- Diagnosed with a mental disorder by neurologists or psychiatrists
- With a history of drug addiction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Participants in the intervention group will participate in a 6-week Connect Active Program (CAP).
Young participants will be the pioneers and take the initiative to change their inactive and sedentary lifestyles by including exercise into their daily routines about once a week, at least 45 minutes each time.
For instance, they could organize family field trips to waterfront parks or involve their older family members in their favorite sports.
All walking activities included in the study should be done with the Nike Run Club App for record and outcome measures.
For other activities in CAP, participants will use other apps following that week's topic.
For instance, they will use Google Maps to search for the best routes to their destinations; transportation apps such as Kowloon Motor Bus, Long Win Bus, and Mass Transit Railway apps to search for stops and exits.
|
Younger adults will help older adults increase their digital literacy, skills, and desire to exercise and become more physically active via the proposed intervention.
The Connect Active Program will consist of two components: walking exercises and mobile apps.
|
|
No Intervention: Control group
Participants in the control group will be provided with a leaflet as usual care.
The pamphlet contains information about the benefits and some instructions for walking exercises for older adults.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aerobic Capacity and Endurance Evaluation with 6-Minute Walk Test (6MWT)
Time Frame: Baseline, Week 6
|
It is initially created to assist in the examination of cardiopulmonary patients developed by the American Thoracic Society.
It is a light-intensity exercise test to evaluate the aerobic capacity, endurance and oxygen saturation.
|
Baseline, Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobility and Balance Assessment with Time Up and Go Test
Time Frame: Baseline, Week 6
|
To assess mobility, movement, static balance and dynamic in people with musculoskeletal impairments, conditions related to aging, quality of life, and pain.
The instructions are given as standing up from a chair, walking 3 meters, turning, and back to sit.
|
Baseline, Week 6
|
|
Quality of Life Measurement
Time Frame: Baseline, Week 6
|
Quality of life will be evaluated utilizing the World Health Organization Quality of Life-BREF (WHOQOL-BREF).
It contains four realms: physical health, psychological health, social relationships, and environment.
A 5-point response scale is used in the scale.
WHOQOL-BREF has good validity and reliability.
|
Baseline, Week 6
|
|
Happiness Level Determination
Time Frame: Baseline, Week 6
|
A 29-item measure of happiness; from 1 "strongly agree," to 6, "strongly disagree."
The scale's reliability was 0.91.
|
Baseline, Week 6
|
|
Intergenerational Relationship Appraisal
Time Frame: Baseline, Week 6
|
The intergenerational relationship quality scale (IRQS) to appraise the changes in intergenerational relationships, this questionnaire will allow the older participants to self-rate the relationship between the two generations.
A 5-point response scale is applied in the scale.
|
Baseline, Week 6
|
|
Subjective Quality Assessment of Mobile Apps
Time Frame: Baseline, Week 6
|
The 4-item subjective quality subscale of the Mobile Application Rating Scale (MARS) will be deployed to assess the overall quality of mobile apps involved in this study.
MARS incorporates four objective quality subscales (engagement, functionality, aesthetics, and information quality) and one subjective quality subscale.
Since a lengthy questionnaire would be complicated for the older participants to complete, we will only adopt the subjective quality subscale.
All four items are assessed on a 5-point scale.
The subjective quality subscale showed excellent internal consistency (alpha = 0.93) and interrater reliability intraclass correlation coefficient (ICC = 0.83).
Higher scores indicate a higher level of subjective quality.
|
Baseline, Week 6
|
|
Participant Feedback Collection
Time Frame: Baseline, Week 6
|
Semi-structured interview for older and younger participants: Individual interviews will be carried out by the Research Assistant upon completion of the CAP (post-test).
They will be asked to comment on the perceived benefits, limitations and barriers in the program and the mobile apps, usefulness of the mobile apps, and recommendations for improving the CAP to meet their needs.
Details of the questionnaire.
|
Baseline, Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mimi MY Tse, PhD, School of Nursing and Health Studies, Hong Kong Metropolitan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
March 31, 2024
Study Completion (Actual)
May 16, 2024
Study Registration Dates
First Submitted
January 1, 2024
First Submitted That Met QC Criteria
January 1, 2024
First Posted (Actual)
January 11, 2024
Study Record Updates
Last Update Posted (Actual)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 12, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Elderly
-
University of Rome Foro ItalicoCompletedAging | Elderly | Frail Elderly | Aging Frailty | Sarcopenia in ElderlyItaly
-
DSM Nutritional Products, Inc.CompletedFrail Elderly | Pre-frail ElderlyNetherlands
-
Maimonides Medical CenterCompletedElderly | Frail Elderly | Hospitalization | Geriatrics
-
University of ThessalyCompletedFunctionality, Falls, Elderly, Fall Prevention, Exercise Elderly, Assessment, Rehabilitation, Community-DwellingGreece
-
Indian Council of Medical ResearchSt Johns Medical College Hospital, Bangalore, IndiaRecruiting
-
Burdur Mehmet Akif Ersoy UniversityPamukkale UniversityCompleted
-
Hospital Israelita Albert EinsteinConselho Nacional de Desenvolvimento Científico e Tecnológico; Paulo de Tarso...Completed
-
Istanbul Medipol University HospitalCompleted
-
Seoul National University HospitalCompleted
-
Purdue UniversityCompleted
Clinical Trials on Connect Active Program
-
University of ManitobaWithdrawnThe CONNECT Program: Testing a Telephone-Based Mental Health Intervention for Older Adults (CONNECT)Depression | Anxiety | Loneliness | Social IsolationCanada
-
Color Health, Inc.CompletedCancer | Survivorship | Caregiver Burnout | Caregiving StressUnited States
-
VA Boston Healthcare SystemCompleted
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; United States Department of Agriculture... and other collaboratorsCompleted
-
Indiana UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsCompletedDepression | Type2 DiabetesUnited States
-
Columbia UniversityNational Institute of Mental Health (NIMH)Completed
-
Air Liquide Santé InternationalCompletedChronic Obstructive Pulmonary Disease (COPD) | Obesity Hypoventilation Syndrome (OHS) | Chronic Respiratory Failure With HypercapniaFrance
-
Minnesota Department of HealthCompleted
-
New York UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD); Hofstra...Not yet recruitingChildhood Apraxia of Speech
-
University of South CarolinaNational Institute of Nursing Research (NINR)RecruitingConnect Through PLAY: A Staff-based Physical Activity Intervention for Middle School Youth (Connect)Physical Activity | Obesity PreventionUnited States