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临床试验/NCT07071168
NCT07071168尚未招募不适用

Developing A Hearing-physical Activity Dual-task Training App for Older Adults With Hearing Loss: A Mixed Method Study

The Hong Kong Polytechnic University0 个研究点目标入组 60 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Physical activity

研究概览

简要总结

Background

By 2050, approximately 2.5 billion people are expected to experience some degree of age-related hearing loss (ARHL). Greater ARHL is associated with decreased communication, reduced physical activity and social engagement, increased depressive symptoms, cognitive decline and a higher risk of dementia. While previous studies highlight the benefits of combing hearing training and physical activity for older adults with ARHL, existing interventions are very limited. Additionally, the development of previous interventions often lacks end-user involvement, resulting in low adherence.

Objectives

This study aims to co-design a hearing-physical activity dual-task training app with older adults with ARHL, the potential end-users; to assess the feasibility and acceptability of the app using based on the theoretical framework of acceptability; and to examine its preliminary effects on improving physical activity, communication, loneliness, depressive symptoms and cognitive functions for older adults with age-related hearing loss.

Hypothesis to be tested

The app is feasible and acceptable to participants. Upon completing the 10-week intervention, the intervention group will report significantly greater improvements in physical activity, communication, loneliness, depressive symptoms and cognitive functions than the control group. These findings will support subsequent investigations in a larger-scale randomized controlled trial.

Research Design and Methods

This study consists of three phases. Phase 1: co-develop a prototype app that combines hearing and physical activity dual-task trainings, incorporating a music therapy component for older adults with ARHL. Co-design workshops will be conducted following the community-based participatory research methodology, where participants will engage in plenary and breakout sessions. Phase 2: conduct a two-arm, single-blinded, pilot randomized controlled trial. Phase 3: conduct individual semi-structured interviews immediately after the intervention. Four process evaluation outcomes will be observed, namely feasibility, fidelity, and acceptability, along with implementation barriers and facilitators. Participants will include Chinese adults aged 60 years or older, with mild-to-moderate HL with a pure-tone average of 20-50 dB across octave frequencies 0.5 to 4kHz in both ears.

Main outcome measures Physical activity levels.

Data analysis

Descriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used.

Expected results

A hearing-physical activity dual-task training app prototype, available in both Cantonese and Mandarin, will be co-designed, tested and refined to a final version. Participants could benefit from incorporating tailored intervention for physical activity with auditory rehabilitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •The inclusion criteria are: (1) ethnic Chinese aged 60 years and above living at home; (2) with mild to moderate hearing loss diagnosed by a pure-tone average of 20 to 50 dB across octave frequencies 0.5 to 4kHz in both ears; and (3) no cognitive impairment [score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC)].

排除标准

  • •include: (1) those with a diagnosis of a major neurocognitive disorder; (2) a history of symptomatic stroke or other disease of the central nervous system; 3) a serious medical or psychiatric illness (e.g., severe depression, schizophrenia, bi-polar disorder) or a visual impairment that would interfere with using app.

研究组 & 干预措施

Physical activity group

Experimental

A hearing-physical activity training

干预措施: hearing-physical activity training (Behavioral)

Control group

Placebo Comparator

waiting list group

干预措施: hearing-physical activity training (Behavioral)

结局指标

主要结局

Physical activity

时间窗: 7 days

Physical activity levels (objectively): A wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count. 44 Physical activity levels (subjectively): will be measured using the Chinese version of the 7-item International Physical Activity Questionnaire, which assesses the durations of time in the past 7 days that respondent stayed sedentary or engaged in ambulatory, moderate or vigorous physical activities. It has good psychometrics at the scale- and subscale- levels and significantly correlated with the objective physical activity measures.

次要结局

  • Loneliness(2 weeks)
  • Communication(2 weeks)
  • Depressive symptoms(2 weeks)
  • Cognitive function(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ZHAO Yan Ivy

Assistant Professor

The Hong Kong Polytechnic University

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