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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorChinese University of Hong Kong

About this trial

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).

Eligibility criteria

Qualifiers

Aged ≥60 years;

Ethnic Chinese; able to read, write and speak Cantonese

Having a Hong Kong ID;

Willing to wear an accelerometer on the wrist for a week to assess sleep parameters at T0, T1, and T2.

Disqualifiers

Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q);

Currently regularly practicing a moderate-intensity PA program such as brisk walking or Tai Chi (≥3 times a week, ≥30 minutes/session);

Currently receiving or scheduled to receive CBT-I during the study period;

Score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE).

Trial design

Treatments tested in this trial

  • Brisk walking
  • Cognitive-behavioral therapy for insomnia

Treatment groups

92 Participants
are divided into 2 treatment groups