The Chinese University of Hong Kong
Hong Kong
NCT Number: NCT06850272
This study is a single-blinded (outcome assessor) and parallel-group non-inferiority RCT. Chinese older adults aged ≥60 years with chronic primary insomnia will be randomized evenly (1:1) to either the brisk walking training group or the CBT-I group. Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week). Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week). Self-reported and objective sleep outcomes are measured at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3).
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week).
Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week).
Time frame: 12 months
Score of the Insomnia Severity Index (ISI) measured at at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3).
Time frame: 12 months
Structured clinical interview to confirm insomnia remission based on the DSM-5 criteria at 12 months after completion of the intervention
Time frame: 12 months
Sleep quality will be measured by the 19-item Pittsburg Sleep Quality Index (PSQI) at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3)
Time frame: 12 months
Seven-day ActiGraph at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3)
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
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