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

NCT06850272 | Not Yet Recruiting

• 1 other identifier: ECS24610123
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Insomnia remission

  12 months

• Sleep quality

  12 months

• Seven-day ActiGraph

  12 months

Study Arms (2)

Brisk walking group

EXPERIMENTAL

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

CBT-I group

ACTIVE COMPARATOR

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

Interventions

Brisk walking BEHAVIORAL

Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week).

Brisk walking group

Cognitive-behavioral therapy for insomnia BEHAVIORAL

Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week).

CBT-I group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Score ≥10 in the Insomnia Severity Index (ISI) (presence of insomnia)
• Experiencing any one of the following symptoms for ≥3 days per week
• Difficulty initiating sleep; OR
• Difficulty maintaining sleep; OR
• Early-morning awakening with inability to return to sleep

You may not qualify if:

• 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).
• Working nightshifts and unable/unwilling to discontinue such work pattern;
• 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;
• Use of antidepressant or antipsychotic medication or under treatment of other serious diseases (e.g., cancer chemotherapy) known to affect sleep;
• Presence of any serious chronic diseases which affect sleep (e.g., cancer, autoimmune diseases).
• Having a serious somatic condition preventing the participation of brisk walking training/CBT-I.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Zixin Wang, PhD

CONTACT

+852 22528474; wangzx@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)