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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Physical activity levels (objectively) [Срок оценки: 10 weeks]
• Physical activity levels (subjectively) [Срок оценки: 10 weeks]

Вторичные конечные точки (3)

• Loneliness [Срок оценки: 10 weeks]
• Communication [Срок оценки: 10 weeks]
• Health-related quality of life (HRQL) [Срок оценки: 10 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06878339 · 09230027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗