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

NCT ID: NCT06850272

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Brisk walking

Intervention Type: BEHAVIORAL

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

CBT-I group

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

Group Type: ACTIVE_COMPARATOR

Cognitive-behavioral therapy for insomnia

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Zixin Wang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Central Contacts

Zixin Wang, PhD

Role: CONTACT

wangzx@cuhk.edu.hk

+852 22528474

Facility Contacts

Zixin Wang, PhD

Role: primary

wangzx@cuhk.edu.hk

+852 22528474

Other Identifiers

ECS24610123

Identifier Type: -

Identifier Source: org_study_id