Primary InsomniaNCT06850272
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
A study testing Brisk walking and Cognitive-behavioral therapy for insomnia in people with Primary Insomnia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Brisk walking and Cognitive-behavioral therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Mar 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Difficulty initiating sleep; OR
- Difficulty maintaining sleep; OR
- Early-morning awakening with inability to return to sleep
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The Chinese University of Hong Kong
Hong Kong
Zixin Wang, PhD, +852 22528474, wangzx@cuhk.edu.hk
About this study
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
- Being tested
- Brisk walking, Cognitive-behavioral therapy for insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brisk walkingBehavioural
Participants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week).
Cognitive-behavioral therapy for insomniaBehavioural
Participants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Cognitive-behavioral therapy for insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (3)
Insomnia remission
Structured clinical interview to confirm insomnia remission based on the DSM-5 criteria at 12 months after completion of the intervention
Measured: 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)
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start10 Mar 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zixin Wang, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850272
- Sponsor's protocol ID
- ECS24610123
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data contains sensitive behaviors and conditions.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06850272
- Acronym / sponsor ID
- ECS24610123
- Conditions
- Primary Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brisk walking group | Experimental | Behavioral: Brisk walkingParticipants 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 | Active comparator | Behavioral: Cognitive-behavioral therapy for insomniaParticipants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brisk walkingParticipants in the brisk walking training group receive an eight-week instructor-led interval brisk walking training (40 minutes/session, three sessions/week). | Behavioural | Brisk walking group |
| Cognitive-behavioral therapy for insomniaParticipants in the CBT-I group receive standard-of-care group-based eight-session CBT-I (one session/week). | Behavioural | CBT-I group |
Primary outcome
Score of the Insomnia Severity Index (ISI)
Time frame: 12 months
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).
3 secondary outcomes
Insomnia remission
Time frame: 12 months
Sleep quality
Time frame: 12 months
Seven-day ActiGraph
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No. The individual participant data contains sensitive behaviors and conditions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brisk walking and Cognitive-behavioral therapy for insomnia in people with Primary Insomnia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zixin Wang, PhD (+852 22528474, wangzx@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the Insomnia Severity Index (ISI) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.