跳至主要内容
临床试验/NCT07365020
NCT07365020已完成不适用

A Feasibility Randomised Controlled Trial of Culturally Appropriate Physical Activity Promotion Strategies Among Older Chinese Adults in the UK

University of Manchester1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Recruitment rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

The culturally appropriate physical activity promotion strategies

Experimental

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

干预措施: The culturally appropriate PA promotion strategies (Behavioral)

WHO physical activity guideline group

Active Comparator

The printed leaflet of recommendations from the WHO physical activity guideline for older adults

干预措施: WHO leaflet group (control) (Behavioral)

结局指标

主要结局

Recruitment rate

时间窗: Baseline

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.

Compliance rate and follow-up rate.

时间窗: 18 weeks

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.

Adherence

时间窗: 12 week

In this study, adherence was mainly assessed by the number of workshops attended by the participants.

Acceptability

时间窗: 12 to 18 week

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.

次要结局

  • Subjective measures of physical activity(Baseline, 12-week and 18-week)
  • Objective measures of physical activity(baseline, 12-week and 18-week)
  • COM-B questionnaires(Baseline, 12-week and 18-week)
  • Physical Function(Baseline, 12-week and 18-week)
  • Health-related quality of life(Baseline, 12-week and 18-week)
  • Adverse events(Whole study period-18 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Yang

Principal Investigator

University of Manchester

研究点 (1)

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