A Digitally Supported Outdoor Physical Activity Intervention for Mildly Frail Older Adults: a Hybrid Type 1 Effectiveness-Implementation Cluster Randomized Controlled Trial (OUTDOOR-FIT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Physical Activity Level
研究概览
简要总结
The aging population in Hong Kong is projected to reach 36.6% by 2046, with roughly 16.6% of older adults estimated to be mildly frail-a condition linked to higher risks of falls, hospitalization, and mortality. While physical activity (PA) is a key modifiable determinant of frailty, a major service gap exists for mildly frail older adults, who lack tailored support, resources, and long-term self-management programs. Although Hong Kong features over 440 public open spaces equipped with senior-friendly outdoor exercise facilities (OEFs), older adults often lack awareness and knowledge on how to utilize them safely for aerobic, strength, and balance training. Furthermore, existing PA interventions often overlook social-ecological perspectives and fail to optimize built environment resources or address digital literacy barriers to sustain long-term behavior change.
To bridge these gaps, our team developed and preliminary-tested OUTDOOR-FIT, a complex, theory-driven, socio-ecological mHealth intervention. OUTDOOR-FIT synergizes Hong Kong's built environment (OEFs), social and volunteer support, individual goal-setting, and digital health technology (a contextually tailored mobile Application) to empower mildly frail older adults to self-manage their PA habits. Building upon promising preliminary findings and qualitative feedback from our initial pilot RCT, the intervention has been refined to incorporate neighborhood OEF environmental audits, supervised outdoor experiential practice sessions, and a train-the-trainer volunteer model to support digital literacy and engagement.
The main objective of this study is to evaluate the clinical effectiveness and real-world implementation of the refined OUTDOOR-FIT intervention using a hybrid type 1 effectiveness-implementation design. Primary effectiveness outcomes include physical activity levels, exercise self-efficacy, mental well-being, chronic pain, and social loneliness measured immediately post-intervention, as well as at 3-month and 6-month follow-ups. Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, secondary implementation outcomes include Reach, Effectiveness, Adoption, Implementation fidelity, and Organizational Maintenance.
This study adopts a mixed-methods design embedded within a two-arm cluster randomized controlled trial (cluster RCT) involving community service units. Mildly frail older adults will be cluster-randomized into either (i) the OUTDOOR-FIT intervention group or (ii) a control group.
Quantitative analysis will be conducted to evaluate the immediate and sustained effectiveness of the intervention across the primary health outcomes. The qualitative component will consist of semi-structured interviews with older adult participants and community stakeholders to evaluate intervention adoption, implementation barriers, and long-term organizational maintenance.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •community-dwelling men or women aged 60 years or over
- •self-report of mild frailty as determined by a score of ≥ 1 and ≤ 3 on the Chinese version of the Fatigue, Resistance, Ambulation, Illness, and Loss of Weight (FRAIL) scale
- •passing the Physical Activity Readiness- Questionnaire (PAR-Q)
- •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 (MVPA) for at least 150 minutes per week
- •scoring 0 or 4/5 in the FRAIL scale
- •mildly frail older adults without cognitive ability to respond to self-reported questionnaires
研究组 & 干预措施
mHealth Group
Receive 4 face-to-face session and self usage of the "Outdoor Rehab-Fit" Mobile App
干预措施: OUTDOOR-FIT (Behavioral)
Active Control
Receive 4 face-to-face or online exercise knowledge and practical workshops for mildly frail older adults
干预措施: Active Control (Behavioral)
结局指标
主要结局
Physical Activity Level
时间窗: Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7)
Physical activity level will be assessed using the Chinese version of the Community Healthy Activities Model Program for Seniors questionnaire (CHAMPS-C) to evaluate weekly frequency and duration of various physical activities in older adults. The primary metric derived is the total duration (hours per week) spent on physical activities. The score ranges from 0 to 168 hours per week, with higher scores indicating a higher level of physical activity.
次要结局
- Exercise Self-Efficacy(Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7))
- Mental Well-Being(Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7))
- Pain Severity(Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7))
- Social Loneliness(Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7))
- Organizational Readiness for Adoption(Baseline)
- Implementation Fidelity(Baseline, immediately post-intervention (Month 1))
- Organizational Intention to Maintain(Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months post-intervention (Month 7))
研究者
LEE Lok Chun Janet
Research Assistant Professor
The Hong Kong Polytechnic University