NCT06850272

Brisk Walking Training Compared with Cognitive Behavioral Therapy for the Treatment of Chronic Primary Insomnia in People Aged 60 Years or Above: a Randomized, Partially Blinded, Non-inferiority Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Brisk walking	Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week).
BEHAVIORAL	Cognitive-behavioral therapy for insomnia	Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week).

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-02-27
• Last updated: 2025-02-27

Locations

1 site across 1 country: Hong Kong