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Recruiting NCT06648707

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

No phase Interventional Community-dwelling Seniors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual-task training.
Who it may be relevant to
Registry conditions: Community-dwelling Seniors. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Recruitment rate [Time frame: After baseline, before randomization]
  • Attendance rate [Time frame: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.]
  • Retention rate [Time frame: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.]
  • Satisfaction rate [Time frame: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.]
Secondary outcome measures (12)
  • Completion rate of the interventionist [Time frame: End of study, up to 2 years]
  • Time to recruit target sample size [Time frame: Before baseline]
  • Factors influencing older adults' decision to participate and staff of the community centre to organise the activity [Time frame: At the end of recruitment briefing, before baseline]
  • Change from baseline subjective memory complaints at 6 weeks [Time frame: 6 weeks after baseline]
  • Change from baseline subjective memory complaints at 12 weeks [Time frame: 12 weeks after baseline, only for waitlist control group]
  • Change from baseline working memory at 6 weeks [Time frame: 6 weeks after baseline]
  • Change from baseline working memory at 12 weeks [Time frame: 12 weeks after baseline, only for waitlist control group]
  • Change from baseline executive function at 6 weeks [Time frame: 6 weeks after baseline]
  • Change from baseline executive function at 12 weeks [Time frame: 12 weeks after baseline, only for waitlist control group]
  • Change from baseline cognitive status at 6 weeks [Time frame: 6 weeks after baseline]
  • Change from baseline cognitive status at 12 weeks [Time frame: 12 weeks after baseline, only for waitlist control group]
  • Qualitative feedback [Time frame: At the end of the study, up to 2 years]

Eligibility criteria

Inclusion criteria

(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.

Exclusion criteria

contraindications to chair-based or stepping exercises.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Hong Kong · 1 center
  • Community centre — Hong Kong

Identifiers

NCT: NCT06648707 · UW 23-575

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗