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NOT YET RECRUITING
NCT06850272
NA

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

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

92

Start Date

2025-03-10

Completion Date

2026-09-30

Last Updated

2025-02-27

Healthy Volunteers

No

Interventions

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).

Locations (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong