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Not yet recruiting NCT06850272

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

No phase Interventional Primary Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brisk walking, Cognitive-behavioral therapy for insomnia.
Who it may be relevant to
Registry conditions: Primary Insomnia. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • 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).
  • 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).

Primary outcome measures

  • Score of the Insomnia Severity Index (ISI) [Time frame: 12 months]
Secondary outcome measures (3)
  • Insomnia remission [Time frame: 12 months]
  • Sleep quality [Time frame: 12 months]
  • Seven-day ActiGraph [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT06850272 · ECS24610123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗