An interventional study of hearing-physical activity training in Hearing Loss, Age-Related, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 60 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Prevention
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.
66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 45 interventional studies indexed under Presbycusis.
Browse Presbycusis studies →The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
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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)].
The exclusion criteria 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.
A hearing-physical activity training
Behavioral: hearing-physical activity training
waiting list group
Behavioral: hearing-physical activity training
In this study, the intervention was designed to span 10 weeks. Based on our previous study, participants will attend hearing training 30 minutes/day, 5 days/week, The physical activity program will be performed at moderate intensity, 60 min/day, 3 days/week.39
Physical activity
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.
Time frame: 7 days
Loneliness
Loneliness will be measured using the 6-item De Jong Gierveld Loneliness Scale (Chinese version).47 It consists of two subscales: emotional loneliness and social loneliness. The scale has been validated and recommended as reliable (Cronbach's a=0.76, the intra-class correlation coefficients ranged from 0.98 to 1.00).
Time frame: 2 weeks
Communication
Communication will be measured using Chinese version of the Hearing Handicap Inventory for the elderly (HHIE)48
Time frame: 2 weeks
Depressive symptoms
Depressive symptoms will be measured by PHQ-9, which is a 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression
Time frame: 2 weeks
Cognitive function
Cognitive function will be measured by the Hong Kong-Montreal Cognitive Assessment (HK-MoCA).
Time frame: 2 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Dec 2027, 27 months later.
Of 25 interventional studies with no phase under Presbycusis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 58. This study's planned 27 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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