- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07365020
Feasibility RCT of Culturally Appropriate Physical Activity Strategies for Older Chinese Adults in the UK
A Feasibility Randomised Controlled Trial of Culturally Appropriate Physical Activity Promotion Strategies Among Older Chinese Adults in the UK
The goal of this study was to explore the feasibility and acceptability of conducting a feasibility randomised controlled trial of culturally appropriate physical activity (PA) promotion strategies among older Chinese adults living in the UK.
The main questions the study aimed to answer were:
Whether older Chinese adults in the UK were willing to take part in the study and to be randomly assigned to a group
Whether participants were willing to remain in the study for its full duration
Whether participants were willing to engage with the PA promotion strategies, including attending workshops, using a logbook, wearing a pedometer, and joining a social media support group
Whether participants found the PA promotion strategies and outcome measures acceptable
Whether physical activity, physical function, and quality of life showed changes in the intervention and control groups
Researchers compared the culturally appropriate PA promotion strategies with a World Health Organization (WHO) PA recommendation leaflet. The study lasted 18 weeks, including a 12-week intervention and a 6-week follow-up.
Participants in the intervention group received culturally appropriate PA promotion materials, including booklets, workshops, a social media support group, a resistance band for strength and balance exercises, and a pedometer.
Participants in the control group received a WHO PA information leaflet and a pedometer.
Participants in both groups completed data collection at three time points. At each time point, participants were asked to wear a pedometer for 7 days.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Great Manchester
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Manchester, Great Manchester, United Kingdom, M13 9PL
- The University of Manchester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 60 years or above;
- Self-identified as Chinese ethnicity;
- Speaking either Cantonese, Mandarin and/or English;
- Able to read and write Chinese or English;
- No time requirement for their stay in the UK, but they should have settled in the UK as residents and not as tourists.
- Self-report not meeting the PA guidelines for older adults (engaging in less than 150 minutes of moderate-level PA each week and performing balance, strength, and flexibility exercises less than twice a week);
- Self-report being able to walk around at home independently;
- Can provide informed consent.
Exclusion Criteria:
- Those who self-report that they already meet the PA guidelines (engaging in more than 150 minutes of moderate-level PA each week and performing balance, strength, and flexibility exercises more than twice a week), as this study focuses on older Chinese adults with insufficient PA.
- Those who plan to be away from Manchester for more than 2 months during the intervention period.
- Participants with diseases where exercise is contraindicated will be excluded to ensure the safety of the participants. A self-reported approach will be used to identify these conditions, including cognitive impairment, as it is considered more acceptable by PCIE participants than formal assessments such as the MMSE (Mini-Mental State Examination), which were viewed as burdensome. To mitigate potential bias, the research team will monitor participants throughout the study. Participants who show signs of impairment after giving consent, such as difficulty completing data collection or following instructions, will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: The culturally appropriate physical activity promotion strategies
The culturally appropriate physical activity promotion strategies were developed based on 27 BCTs and will be delivered through three parts: a series of booklets, three workshops and a virtual social media support group
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The intervention was developed based on the Behaviour Change Wheel, aiming to increase participants' capability, opportunity, and motivation to engage in physical activity. It consisted of three components: printed materials, group workshops, and an online social media support group.
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Active Comparator: WHO physical activity guideline group
The printed leaflet of recommendations from the WHO physical activity guideline for older adults
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In the control group, participants received a printed leaflet outlining World Health Organization (WHO) physical activity recommendations for older adults.
Participants were encouraged to follow these guidelines, including 150-300 minutes of moderate-intensity or 75-150 minutes of vigorous-intensity aerobic activity per week, along with strength and balance exercises twice weekly, at a time and place convenient to them.
No additional support was provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Recruitment rate
Time Frame: Baseline
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We aimed to recruit at least 30 participants within eight weeks.
Detailed records were kept of the total number of potential participants approached by the researcher, the number of participants who attend the screening, and the number of participants who are ultimately included in the study.
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Baseline
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Compliance rate and follow-up rate.
Time Frame: 18 weeks
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Participants were not fully withdrawn from the study solely due to discontinuation of or noncompliance with the intervention.
For example, participants could choose to stop attending workshops or participating in the social media group while still remaining willing to complete data collection activities.
Alternatively, participation could be discontinued based on clinical judgment.
Every effort was made to collect as much data as possible to maintain the integrity of the study.
Reasons for participants' exit from the trial were recorded separately.
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18 weeks
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Adherence
Time Frame: 12 week
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In this study, adherence was mainly assessed by the number of workshops attended by the participants.
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12 week
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Acceptability
Time Frame: 12 to 18 week
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Qualitative interviews.
At the end of the study, about 50% of participants (including those who withdraw from the trial) was invited for follow-up interviews.
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12 to 18 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Subjective measures of physical activity
Time Frame: Baseline, 12-week and 18-week
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Subjective measurement was conducted using the Chinese version of the Physical Activity Scale for the Elderly (PASE).
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Baseline, 12-week and 18-week
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Objective measures of physical activity
Time Frame: baseline, 12-week and 18-week
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A pedometer (Realalt 3DTriSport 3D Pedometer; 3DTriSport Pedometer for Walking with Clip and Lanyard - Realalt) was used to monitor participants' PA level (i.e., step counts).
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baseline, 12-week and 18-week
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COM-B questionnaires
Time Frame: Baseline, 12-week and 18-week
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Brief COM-B questionnaires was used to assess the perceived capability, opportunity and motivation for PA behaviour among older Chinese adults in the UK.
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Baseline, 12-week and 18-week
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Physical Function
Time Frame: Baseline, 12-week and 18-week
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The Short Physical Performance Battery (SPPB) will be used to assess the potential change of physical function
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Baseline, 12-week and 18-week
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Health-related quality of life
Time Frame: Baseline, 12-week and 18-week
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The CASP-12 (Control, Autonomy, Self-realisation, and Pleasure-12) questionnaire was used to measure older adults' health-related quality of life
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Baseline, 12-week and 18-week
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Adverse events
Time Frame: Whole study period-18 weeks
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A safety reporting protocol was followed for managing related and unexpected serious adverse events (SAEs) and directly attributable adverse events (AEs).
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Whole study period-18 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-19749-37005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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