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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Insomnia
• Intervention / Treatment: Behavioral: Brisk walking; Behavioral: Cognitive-behavioral therapy for insomnia

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zixin Wang, PhD; Phone Number: +852 22528474; Email: wangzx@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong
    • Contact: Zixin Wang, PhD; Phone Number: +852 22528474; Email: wangzx@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged ≥60 years;
2. Ethnic Chinese; able to read, write and speak Cantonese
3. Having a Hong Kong ID;
4. Willing to wear an accelerometer on the wrist for a week to assess sleep parameters at T0, T1, and T2.
5. Score ≥10 in the Insomnia Severity Index (ISI) (presence of insomnia)

6. Experiencing any one of the following symptoms for ≥3 days per week

   1. Difficulty initiating sleep; OR
   2. Difficulty maintaining sleep; OR
   3. Early-morning awakening with inability to return to sleep

Exclusion Criteria:

1. Score ≥1 in the Chinese version of the Physical Activity Readiness Questionnaire (PAR-Q);
2. Currently regularly practicing a moderate-intensity PA program such as brisk walking or Tai Chi (≥3 times a week, ≥30 minutes/session);
3. Currently receiving or scheduled to receive CBT-I during the study period;
4. Score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE).
5. Working nightshifts and unable/unwilling to discontinue such work pattern;
6. Having a diagnosis of a major depressive disorder, anxiety disorders or other severe mental disorder (bipolar disorders, psychosis). Those with mild depression or anxiety disorders will not be excluded;
7. Use of antidepressant or antipsychotic medication or under treatment of other serious diseases (e.g., cancer chemotherapy) known to affect sleep;
8. Presence of any serious chronic diseases which affect sleep (e.g., cancer, autoimmune diseases).
9. Having a serious somatic condition preventing the participation of brisk walking training/CBT-I.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brisk walking group; Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week).	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).
Active Comparator: CBT-I group; Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of the Insomnia Severity Index (ISI)	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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia remission	Structured clinical interview to confirm insomnia remission based on the DSM-5 criteria at 12 months after completion of the intervention	12 months
Sleep quality	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)	12 months
Seven-day ActiGraph	Seven-day ActiGraph at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3)	12 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: February 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: ECS24610123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data contains sensitive behaviors and conditions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No