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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Connect Active Program
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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