Clinical trial NCT06326710: The 'Outdoor Rehab-Fit' App-based Physical Activity Education Intervention for Frail Older Adults in Hong Kong
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Frailty
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility outcome: Recruitment rate
timeFrame: Baseline
measure: Feasibility outcome: Intervention completion rate
timeFrame: Month 1
measure: Feasibility outcome: Attrition rate
timeFrame: Month 1
measure: Feasibility outcome: Attendance
timeFrame: Month 1
measure: Acceptability outcome: Perceived Usefulness on Outdoor Rehab-Fit App
timeFrame: Month 1
measure: Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program
timeFrame: Month 1
Secondary outcomes:
measure: Change in Physical activity level (Objective) at 1 month and 3 months
timeFrame: Baseline, Month 1, Month 3
measure: Change in Physical activity level (Subjective) at 1 month and 3 months
timeFrame: Baseline, Month 1, Month 3
measure: Change in Exercise self-efficacy at 1 month and 3 months
timeFrame: Baseline, Month 1, Month 3
measure: Change in Mental well-being at 1 month and 3 months
timeFrame: Baseline, Month 1, Month 3
measure: Change in usage of outdoor exercise facilities
timeFrame: Baseline, Month 1, Month 3
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Study officials:
References: