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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

ConditionPrimary Insomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorChinese University of Hong Kong

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Brisk walking groupExperimental treatment 1 intervention
Group B: CBT-I groupActive comparator 1 intervention

Trial outcomes

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).

Time frame
12 months

Secondary outcomes

1

Insomnia remission

Structured clinical interview to confirm insomnia remission based on the DSM-5 criteria at 12 months after completion of the intervention

Time frame
12 months
2

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)

Time frame
12 months
3

Seven-day ActiGraph

Seven-day ActiGraph at baseline (T0), after completion of the intervention (T1), and six (T2), and 12 months after T1 (T3)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: