NCT06137859

Brief Summary

The ageing population creates concerns and challenges worldwide. The large number of older adults (aged over 65) in Hong Kong continues to rise as people live longer. This may result in heavy burdens on public services and problems such as a shortage of medical resources. The purpose of this study is to implement a physical literacy-based intervention (PLBI) among older adults in Hong Kong in order to achieve the goal of health promotion. A two-arm cluster randomized controlled trial will be employed in this proposed study. Ten daycare centers for the elderly in Hong Kong will be invited to participate in this study. The intervention group will receive functional fitness training and mastering physical literacy class twice a week with buddy peer support, and they will be asked to keep a reflective writing journal on a daily basis for 12 weeks in total. Participants will be evaluated at baseline (week 0), post-intervention (week 12), and at 6-week follow-up (week 18). This will consist of objective and self-reported measures covering elements within physical literacy (i.e. physical competence, motivation and confidence, knowledge and understanding) and also physical activity levels on an individual basis. The study intends to introduce a conceptual framework of physical literacy for the elderly through an intervention that allows older people to develop daily behaviour habits, which should promote active ageing for the elderly and greater self-esteem in later life. After this study, participants may share their positive experiences, and encourage their peers in the community to become physically literate in the future. In the long run, due to the feasibility and sustainability of these potential programs, this proposed study has the potential to connect seniors through social engagement and contribute to healthy living.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

November 14, 2023

Last Update Submit

August 24, 2024

Conditions

Keywords

Physical literacy

Outcome Measures

Primary Outcomes (2)

  • Physical Competence

    Short Physical Performance Battery (SPPB) will be used to measure the physical competence within the physical literacy of older adults. Huang et al. suggested using a combined and comprehensive kit of assessment tools to measure physical competence, and the SPPB was reported to be able to measure complex capabilities with excellent test-retest reliability, especially in community-dwelling older adults. It is a group of measures that combines the results of the gait speed, chair stand and balance tests, which consist of balance, a timed eight feet walk and chair stands. The scores range from zero (worst performance) to 12 (best performance). It has been used as a predictive tool for possible disability and can aid in monitoring function in older people. The reliability of SPPB has been reported as ICC = 0.75 - 0.89 for all measures.

    Week 0; Week 12; Week 18

  • Objective Physical activity levels

    Accelerometers (Actigraph wGT3X-BT) will be used to measure the physical activity engagement levels of participants, and are categorized as sedentary, light, moderate and vigorous. Data was collected in 60 s epochs to account for elderly people's natural activity levels, as it was shown to present the most acceptable classification accuracy for accelerometer use among older adults. The cut-points developed by Aguilar-Farías et al. was applied to identifying intensity levels. Participants will wear accelerometers at the waist to measure their physical activity engagement levels for at least 8 hours per day, for seven consecutive days.

    Week 0; Week 12; Week 18

Secondary Outcomes (6)

  • Demographic information

    Week 0; Week 12; Week 18

  • Self-report physical activity levels

    Week 0; Week 12; Week 18

  • Knowledge and understanding

    Week 0; Week 12; Week 18

  • Physical literacy

    Week 0; Week 12; Week 18

  • Motivation and confidence

    Week 0; Week 12; Week 18

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive PLBI intervention treatment including weekly-based functional fitness training, mastering physical literacy class, daily based reflective writing, buddy peers support group.

Behavioral: Weekly-based functional fitness trainingBehavioral: Mastering Physical Literacy ClassBehavioral: Daily based reflective writingBehavioral: Buddy Peers Support Group

Control

NO INTERVENTION

Participants will not receive PLBI intervention treatment. However, participants in the control group will be given the same treatment (program and activities) after all data has been collected.

Interventions

Participants will receive a 12-week duration of functional fitness training in daycare centers, which will be implemented twice a week. The 60-minute per session training series will be delivered and guided by qualified elderly health and fitness instructors, who will be provided with a workshop before this intervention. The workshop will be designed and delivered by the research team. The first session will focus on the physical literacy of older adults and the second session will focus on how to lead functional fitness training under the FITT principle for older adults. The main goal of functional training is to improve the range of joint motion, increase muscle strength and flexibility, and boost blood circulation safely. Therefore, symmetry training together with cardiovascular training is the core of the training program. Examples of the main training activities include cardio-full-body exercises, upper-body exercises, lower-body exercises and sensory integrative training.

Intervention

A 30-minute MPLC program will be conducted by experienced elderly health and fitness instructors after WBFFT. This MPLC program aims to enhance the knowledge and understanding of physical literacy. Referring to the newly developed consensus statement, the MPLC includes the following five domains related to the relationship with movement and physical activity throughout life: i) Why physical literacy matters - improves health, well-being and quality of life. ii) Understanding physical literacy - value, enjoy and engage in physical activity for life. iii) Everyone's physical literacy is different - their individual needs and experiences of movement and physical activity. iv) Building physical literacy - think, feel, move and connect with others. v) How experience affects physical literacy - people, places and spaces around us.

Intervention

At the end of the baseline stage of this study, each participant of the intervention group will receive a template notebook for daily-based reflective writing. The required columns consist of the daily diet, physical activity, mood and sleep quality. Participants will be required to write down their behavior in this notebook daily. In each week's functional training course, there will be a life-sharing session, where the participants will be reminded to bring their notebooks and share their daily activities with others. They will receive feedback, advice and encouragement from the instructor and each other. The notebook will be collected during the last week of the intervention.

Intervention

Peer-support groups with buddy members will be arranged in each daycare center. Three pairs of buddies and hence about 6 participants will be formed per group. A total of 6 buddy pairs and 2 groups will be formed per daycare center. Buddy peers will encourage each other to do functional exercises regularly or to perform functional exercises together. The time and place for the practice will be decided among buddy members. A member in each group will be nominated as the leader to assist in the liaison and coordination of group activities. The group will perform weekly group-based functional exercises, and the time and place for the practice will be decided among group members. The group will be encouraged to hold monthly gatherings with their fitness instructor in order to strengthen social support.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • those aged 65 to 74 years old who are registered in a daycare center/unit for the elderly in Hong Kong.
  • the ability to walk eight meters without assistance.
  • able to read and write.

You may not qualify if:

  • neurological disease which impairs mobility, cardiovascular disease which results in shortness of breath or angina on walking up one flight of stairs.
  • cognitive impairment. Participants' cognitive function will be screened by the Chinese Mini-Mental State Examination and those who score below 24 will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sum RKW, Yang Y, Choi SM, Duncan MJ, Li M. Physical literacy-based intervention for older adults: a cluster randomized controlled trial study protocol. Front Sports Act Living. 2024 Jul 17;6:1392270. doi: 10.3389/fspor.2024.1392270. eCollection 2024.

MeSH Terms

Conditions

Motor ActivityBehavior

Study Officials

  • Kim Wai Raymond Sum, EdD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim Wai Raymond Sum, EdD

CONTACT

Siu Ming Choi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

January 1, 2025

Primary Completion

April 1, 2025

Study Completion

December 31, 2025

Last Updated

August 28, 2024

Record last verified: 2024-08