Increasing Physical Activity with a Social Robot-assisted Exercise Intervention in Older Adults with Hearing Loss: a Feasibility and Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Physical activity levels (objectively)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
control group
physical activity at the same intensity level and frequency as the IG without a robot.
干预措施: A social robot KaKa-assisted intervention (Behavioral)
a home-based, social robot-assisted intervention (SRAI) for older adults with hearing loss
This study will feature a 2 kg, 30 cm tall and 20 cm wide, Cantonese-speaking humanoid social robot named KaKa.
干预措施: A social robot KaKa-assisted intervention (Behavioral)
结局指标
主要结局
Physical activity levels (objectively)
时间窗: 10 weeks
A wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count.2
Physical activity levels (subjectively)
时间窗: 10 weeks
will be measured using the Chinese version of the International Physical Activity Questionnaire.
次要结局
- Loneliness(10 weeks)
- Communication(10 weeks)
- Health-related quality of life (HRQL)(10 weeks)