{"type":"trials","record":{"id":30040,"source_id":"clinicaltrials-gov","external_id":"NCT07752615","title":"A Digitally Supported Outdoor Physical Activity Intervention for Mildly Frail Older Adults in Hong Kong","brief_summary":"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.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"The Hong Kong Polytechnic University","enrollment":240,"countries":["Hong Kong"],"start_date":"2027-02-01","completion_date":"2029-03-03","last_update_date":"2026-08-07","source_url":"https://clinicaltrials.gov/study/NCT07752615","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:16.485702+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years to 100 Years","comparator":"Active Control","organization":"The Hong Kong Polytechnic University","interventions":["OUTDOOR-FIT","Active Control"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Physical Activity Level — Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and…","Exercise Self-Efficacy — Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6…","Mental Well-Being — Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 mont…","Pain Severity — Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months p…","Social Loneliness — Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 mont…","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 (M…"],"design_description":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · SINGLE","source_has_results":false},"controlled_terms":["Physical Inactivity Frailty","OUTDOOR-FIT","Active Control"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: physical activity.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07752615","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2027-02-01 to 2029-03-03","comparator":"Active Control","confidence":"structured-source","population":"ALL · 60 Years to 100 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.399Z","intervention":["OUTDOOR-FIT","Active Control"],"participants":240,"study_design":"RANDOMIZED · PARALLEL · SUPPORTIVE CARE · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Physical Activity Level — Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and…","Exercise Self-Efficacy — Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6…","Mental Well-Being — Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 mont…","Pain Severity — Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 months p…","Social Loneliness — Baseline, immediately post-intervention (Month 1), 3 months post-intervention (Month 4), and 6 mont…","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 (M…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"exercise","is_published":true,"match_reasons":["Title contains controlled term: physical activity.","Abstract contains controlled term: exercise, physical activity.","Title supplies longevity context: frail, older adult.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Exercise","slug":"exercise"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/30040","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}