Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic RCT

Официальное название

Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic Randomised Controlled Trial

Обзор

Objectives: This study aims to explore the feasibility and acceptance of group-based dual-task training for prevention of cognitive decline in a pragmatic setting for community-dwelling older adults. The primary objective is to assess recruitment rate, attendance rate, retention rate and satisfaction rate of participants. Study design and participants: This is a pilot pragmatic RCT with waitlist control. First, a co-design approach will be adopted to develop the intervention with the older adults. Then, about six participating community centres will nominate staff or volunteer to receive the training in order to lead the intervention. Informed consent will be sought from the participants and baseline assessment will be conducted. The participants will be randomly allocated to the intervention and control groups in 1:1 ratio using block randomisation with varying block size. At the end of the study, one representative of each participating centre will be invited to provide qualitative feedback. Measurements: The primary outcomes are the feasibility outcomes, namely the recruitment rate, attendance rate, the retention rate, and satisfaction rate of participants. Secondary outcomes include completion rate of the interventionist, time to recruit target sample size, factors influencing older adults' decision to participate and staff of the community centre to organise the activity, subjective memory complaints, working memory, executive function, and cognitive status of participants. A structured questionnaire will be used to collect quantitative outcomes related to effects and satisfaction. Qualitative feedback from representatives of the elderly community centres will be collected according to a semi-structured interview guide. Expected results: The intervention is feasible and highly accepted by the participants and staff of the community centres. Potential effect-related outcomes are to be demonstrated.

Вмешательства

• Другое Dual-task training
  Participants will receive a one-hour face-to-face group-based dual-task training session twice a week for 6 weeks. Training included cognitive components and physical components to be conducted simultaneously.

Первичные конечные точки

• Recruitment rate [Срок оценки: After baseline, before randomization]
• Attendance rate [Срок оценки: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.]
• Retention rate [Срок оценки: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.]
• Satisfaction rate [Срок оценки: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.]

Вторичные конечные точки (12)

• Completion rate of the interventionist [Срок оценки: End of study, up to 2 years]
• Time to recruit target sample size [Срок оценки: Before baseline]
• Factors influencing older adults' decision to participate and staff of the community centre to organise the activity [Срок оценки: At the end of recruitment briefing, before baseline]
• Change from baseline subjective memory complaints at 6 weeks [Срок оценки: 6 weeks after baseline]
• Change from baseline subjective memory complaints at 12 weeks [Срок оценки: 12 weeks after baseline, only for waitlist control group]
• Change from baseline working memory at 6 weeks [Срок оценки: 6 weeks after baseline]
• Change from baseline working memory at 12 weeks [Срок оценки: 12 weeks after baseline, only for waitlist control group]
• Change from baseline executive function at 6 weeks [Срок оценки: 6 weeks after baseline]
• Change from baseline executive function at 12 weeks [Срок оценки: 12 weeks after baseline, only for waitlist control group]
• Change from baseline cognitive status at 6 weeks [Срок оценки: 6 weeks after baseline]
• Change from baseline cognitive status at 12 weeks [Срок оценки: 12 weeks after baseline, only for waitlist control group]
• Qualitative feedback [Срок оценки: At the end of the study, up to 2 years]

Критерии участия

Критерии включения

(i) aged 65 years and above,

(ii) eligible to enrol in activities organised by the community centres,

(iii) no communication problems,

(iv) able to understand and follow instructions,

(v) able to read and write Chinese.

Критерии исключения

contraindications to chair-based or stepping exercises.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Гонконг · 1 центр

• Community centre — Гонконг

Идентификаторы

NCT: NCT06648707 · UW 23-575

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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