Increasing Physical Activity with a Social Robot-assisted Exercise Intervention in Older Adults with Hearing Loss: a Feasibility and Pilot Randomized Controlled Trial

NCT06878339 | Not Yet Recruiting

• 1 other identifier: 09230027
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives To assess the feasibility and acceptability of using a home-based, social robot-assisted intervention (SRAI) for older adults with hearing loss (HL), and to examine the preliminary effects of SRAI on improving physical activity, loneliness, communication, and health-related quality of life in this population. Hypothesis to be tested SRAI is feasible for implementation at home and acceptable to participants. Upon completing the 10-week intervention and the 1-month follow-up, the intervention group (IG) will report significantly greater improvements in measured outcomes. These findings will support subsequent investigations in a larger-scale randomized controlled trial (RCT). Design and subjects A two-arm, single-blinded, pilot RCT with individual semi-structured interviews. Chinese adults aged 65 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. Study instruments This study will feature a 2 kg, 30 cm tall and 20 cm wide, Cantonese-speaking humanoid social robot named KaKa. Interventions Each IG participant will receive SRAI at home for 10 weeks. This will include auditory rehabilitation and 60 min/day, 3 days/week of varied multicomponent physical activity following the World Health Organization's evidence-based recommendations. The control group will engage in physical activity at the same intensity level and frequency as the IG without a robot. 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 Participants could benefit from incorporating tailored intervention for physical activity with auditory rehabilitation.

Conditions

Age-related Hearing Loss

Keywords

age-related hearing loss; physical activity; health-related quality of life

Outcome Measures

Primary Outcomes (2)

• Physical activity levels (objectively)

  A wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count.2

  10 weeks

• Physical activity levels (subjectively)

  will be measured using the Chinese version of the International Physical Activity Questionnaire.

  10 weeks

Secondary Outcomes (3)

• Loneliness

  10 weeks

• Communication

  10 weeks

• Health-related quality of life (HRQL)

  10 weeks

Study Arms (2)

a home-based, social robot-assisted intervention (SRAI) for older adults with hearing loss

EXPERIMENTAL

This study will feature a 2 kg, 30 cm tall and 20 cm wide, Cantonese-speaking humanoid social robot named KaKa.

Behavioral: A social robot KaKa-assisted intervention

control group

ACTIVE COMPARATOR

physical activity at the same intensity level and frequency as the IG without a robot.

Behavioral: A social robot KaKa-assisted intervention

Interventions

A social robot KaKa-assisted intervention BEHAVIORAL

A social robot KaKa-assisted intervention (SRAI) to provide auditory rehabilitation and physical activity program

a home-based, social robot-assisted intervention (SRAI) for older adults with hearing loss; control group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ethnic Chinese aged ≥65 years old living at home;
• with mild to moderate HL with a pure-tone average of 20 to 50 dB across octave frequencies 0.5 to 4kHz in both ears;
• no cognitive impairment \[score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC)\]; and
• informed consent to participate in this study. Loneliness is not a pre-requisite for taking part in the research. Nevertheless, previous findings from a longitudinal cohort study indicate that approximately 46.6% of older adults with hearing loss reported feeling lonely.

You may not qualify if:

• those with a diagnosis of a major neurocognitive disorder;
• a history of symptomatic stroke or other disease of the central nervous system;
• a serious medical or psychiatric illness (e.g., severe depression, schizophrenia, bi-polar disorder) or a visual impairment that would interfere with using a robot or using hearing aids and hearing assistive technologies;
• have limited access to electricity at home.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Presbycusis; Motor Activity

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Ivy Zhao, PhD

CONTACT

+8527664550; yan-ivy.zhao@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 14, 2025
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03