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临床试验/NCT06326710
NCT06326710已完成不适用

The 'Outdoor Rehab-Fit' App-based Physical Activity Education Intervention for Frail Older Adults in Hong Kong: a Feasibility Pilot Randomized Controlled Trial Study Protocol

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program

研究概览

简要总结

In recent years, research teams around the world have developed interventions to educate older adults to use outdoor exercise facilities (OEFs) to improve health outcomes like strength, balance, mobility, PA level, and weight. These interventions employed trainers or therapists to instruct, and monitor exercise training for older adults using the public accessible OEFs. Apart from therapist or trainer-led intervention, an Australian research team developed a mobile application, and social support strategies to help participants to use OEFs to enhance their aerobic and resistance-based PA.

A recent local in-depth qualitative study discovered that OEFs in Hong Kong attracted frailer older adults (i.e., those who recovered from a major illness or who has chronic diseases), and their caregivers to use OEFs to support and maintain their daily PA behavior. Some used OEFs to complement their formal rehabilitation sessions. It appears that OEFs in Hong Kong serves as an important health maintenance space for frailer older adults in the city to "age in place", yet educational training related to OEFs has been lacking over the years. Signage besides the exercise equipment has been the only education material for users over the years.

A mobile app-based physical activity education intervention will be developed for frail old adults in Hong Kong. The intervention has two components: (1) mobile app; and (2) face-to-face group session that teaches the how to use correctly and safely use OEF in public parks to maintain PA habits.

The main objective of this study is to evaluate the feasibility, acceptability, and pilot effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention. Primary outcomes include recruitment rate, retention rate, attrition rate, attendance, perceived usefulness of the app. Secondary outcomes include exercise self-efficacy, mental well-being, physical activity level.

This study adopts a mixed-method design with quantitative and qualitative method. This study is a pilot randomized controlled trial, running for 4 months evaluating of the effectiveness of the mHealth intervention. 40 frail older adults will be randomized into (i) mHealth group or (ii) control group.

Quantitative analysis will be adopted to investigate the effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention on the health outcomes of frail older adults. The qualitative component will consist of semi-structure interviews with the frail older adults to understand the acceptability of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • community-dwelling men or women aged 55 years or over
  • meeting at least one items of the FRAIL scale
  • passing the Physical Activity Readiness- Questionnaire
  • owning a smart phone for daily use
  • signing the informed consent documents

排除标准

  • older adult participants who achieved adequate level of daily physical activity, as defined as engaging in moderate-to-vigorous intensity physical activity for at least 150 minutes per week
  • scoring 0 or 5 in the FRAIL scale

结局指标

主要结局

Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program

时间窗: Month 1

Will be assessed by semi-structured interview guide.

Feasibility outcome: Intervention completion rate

时间窗: Month 1

Will be assessed by a self-invented record form. It is calculated based on the percentage of completion of all intervention components (Including workshop attendance, app usage and outdoor practice).

Acceptability outcome: Perceived Usefulness on Outdoor Rehab-Fit App

时间窗: Month 1

Will be assessed by self-invented questionnaire. It measures participant's perceptions of the app's usefulness. The questionnaire consists of 3 domains.Overall score ranges from 20 to 100. Higher score indicates higher perceived usefulness.

Feasibility outcome: Attendance

时间窗: Month 1

Will be assessed by study record (e.g., attendance log). It is the percentage of sessions attended over all the offered sessions.

Feasibility outcome: Recruitment rate

时间窗: Baseline

Will be assessed by study record e.g., attendance log in recruitment seminar. It is calculated based on the percentage of who signed up for the study and the total number of approached participants.

Feasibility outcome: Attrition rate

时间窗: Month 1

Will be assessed by study record. It indicates the rate at which participants dropped out or discontinued their participation in the study.

次要结局

  • Change in Physical activity level (Objective) at 1 month and 3 months(Baseline, Month 1, Month 3)
  • Change in Exercise self-efficacy at 1 month and 3 months(Baseline, Month 1, Month 3)
  • Change in Physical activity level (Subjective) at 1 month and 3 months(Baseline, Month 1, Month 3)
  • Change in Mental well-being at 1 month and 3 months(Baseline, Month 1, Month 3)
  • Change in usage of outdoor exercise facilities(Baseline, Month 1, Month 3)

研究者

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

LEE Lok Chun Janet

Research Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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