ElderlyNCT06202482
Enhance Physical Activity and Intergenerational Relationship Via Connect Active Program (CAP): a Pilot Randomized Controlled Trial
A study testing Connect Active Program in people with Elderly and Physical Inactivity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly, Physical Inactivity
- What is being tested?
- Connect Active Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2024to 16 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Older Adults/Participants and Younger Adults/Participants:
- Diagnosed with a mental disorder by neurologists or psychiatrists
- With a history of drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Elderly, Physical Inactivity
- Being tested
- Connect Active Program
- Keywords
- Connective Active Program
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connect Active ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: Connect Active Program |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Capacity and Endurance Evaluation with 6-Minute Walk Test (6MWT)
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.
Measured: Baseline, Week 6
Secondary outcomes (6)
Mobility and Balance Assessment with Time Up and Go Test
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.
Measured: Baseline, Week 6
Quality of Life Measurement
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.
Measured: Baseline, Week 6
Happiness Level Determination
A 29-item measure of happiness; from 1 "strongly agree," to 6, "strongly disagree." The scale's reliability was 0.91.
Measured: Baseline, Week 6
Intergenerational Relationship Appraisal
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.
Measured: Baseline, Week 6
Subjective Quality Assessment of Mobile Apps
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.
Measured: Baseline, Week 6
Participant Feedback Collection
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.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2024
- Primary completion31 Mar 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSE Mun Yee Mimi, The Hong Kong Polytechnic University
- Investigators
- Mimi MY Tse, PhD, Principal investigator, School of Nursing and Health Studies, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202482
- Sponsor's protocol ID
- CAP
- Status last verified
- Sep 2024
- First submitted
- 1 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhance Physical Activity and Intergenerational Relationship Via Connect Active Program (CAP): a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06202482
- Acronym / sponsor ID
- CAP
- Conditions
- Elderly, Physical Inactivity
- Keywords
- Connective Active Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 11 Jan 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Connect Active ProgramParticipants 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Younger Adults/Participants:
- Older Adults/Participants:
Key exclusion criteria (3 listed)
- Older Adults/Participants and Younger Adults/Participants:
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 |
|---|---|---|
| Connect Active ProgramYounger 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. | Other | Experimental group |
Primary outcome
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.
6 secondary outcomes
Mobility and Balance Assessment with Time Up and Go Test
Time frame: Baseline, Week 6
Quality of Life Measurement
Time frame: Baseline, Week 6
Happiness Level Determination
Time frame: Baseline, Week 6
Intergenerational Relationship Appraisal
Time frame: Baseline, Week 6
Subjective Quality Assessment of Mobile Apps
Time frame: Baseline, Week 6
Participant Feedback Collection
Time frame: Baseline, Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
Mimi MY Tse, PhD principal investigator
School of Nursing and Health Studies, Hong Kong 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 Connect Active Program in people with Elderly and Physical Inactivity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 11 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: finished, as of the sponsor's last update on 19 Sep 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 Hong Kong. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Capacity and Endurance Evaluation with 6-Minute Walk Test (6MWT) (time frame: Baseline, Week 6). 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 19 Sep 2024.