The 'Outdoor Rehab-Fit' App-based Physical Activity Education Intervention for Frail Older Adults in Hong Kong

Frailty Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326710
• Other study ID #: P0045122
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: The Hong Kong Polytechnic University
• Contact: Janet Lok Chun Lee, PhD
• Phone: 27664354
• Email: lcjlee[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Physical Inactivity

Intervention

Behavioral:
• mHealth
Participants receive 4 sessions of face-to-face or online delivered workshop on how to use the mobile app "Outdoor Rehab-Fit" to support their daily PA level. In addition to the workshop, participants have to go to public parks to practice what they have learnt from the mobile app.
• Health Talk
Participants receive 4 sessions of face-to-face or online delivered health talks on the benefits different types of modified exercises for frail older adults (chair yoga, seated eight-section brocades, Otago and seated multi-component exercise). Each talk has an experiential session.

Locations

Country	Name	City	State
Hong Kong	Department of Rehabilitation Sciences, The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility outcome: Recruitment rate	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.	Baseline
Primary	Feasibility outcome: Intervention completion rate	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).	Month 1
Primary	Feasibility outcome: Attrition rate	Will be assessed by study record. It indicates the rate at which participants dropped out or discontinued their participation in the study.	Month 1
Primary	Feasibility outcome: Attendance	Will be assessed by study record (e.g., attendance log). It is the percentage of sessions attended over all the offered sessions.	Month 1
Primary	Acceptability outcome: Perceived Usefulness on Outdoor Rehab-Fit App	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.	Month 1
Primary	Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program	Will be assessed by semi-structured interview guide.	Month 1
Secondary	Change in Physical activity level (Objective) at 1 month and 3 months	ActiGraphs will be used to collect objective data on moderate-to-vigorous intensity physical activity. It is validated wrist-worn tri-axial accelerometers capturing motion on three axes: vertical (Y), horizontal right-left (X), and horizontal front-back axis at a sampling frequency of 30hz.	Baseline, Month 1, Month 3
Secondary	Change in Physical activity level (Subjective) at 1 month and 3 months	Rapid Assessment of Physical Activity Scale will be used to measure physical activity level. The scale is a 9-item questionnaire that uses a yes-or-no response format. It covers the range of PA levels, from sedentary to regular vigorous PA (RAPA1), as well as strength training and flexibility (RAPA2). A RAPA1 score less than 6 means sub-optimal and is used as a benchmark for not meeting the standard recommendations for physical activity. A RAPA2 score less than 3 is considered as suboptimal, meaning inadequate attainment of anaerobic PA.	Baseline, Month 1, Month 3
Secondary	Change in Exercise self-efficacy at 1 month and 3 months	The Chinese version Exercise self-efficacy will be used to examine the degree of an individual's confidence in exercising regularly. It consisted of nine items rated on an 11-point Likert scale, where '0' represents 'not confident' and '10' represents 'very confident'. Answers from the nine questions were averaged to a score ranged from 0 to 10, with higher scores corresponding to higher confidence in performing exercise and higher exercise self-efficacy.	Baseline, Month 1, Month 3
Secondary	Change in Mental well-being at 1 month and 3 months	The Chinese version of the seven-item short Warwick-Edinburgh Mental Well-Being Scale will be used to measure mental well-bing. The questions, which covered both hedonic and eudemonic aspects, were rated on a 5-point Likert scale, where '1' indicated 'none of the time' and '5' indicated 'all the time'. A mean score was calculated by averaging the scores of the seven questions. A higher score indicated a higher level of well-being.	Baseline, Month 1, Month 3
Secondary	Change in usage of outdoor exercise facilities	A self-developed questionnaire will be used to capture the usage of outdoor exercise facilities. Information on the frequency, duration, and types of outdoor exercise facilities used.	Baseline, Month 1, Month 3