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Completed

NCT Number: NCT03155750

Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia

Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating insomnia disorder delivered by a training course.

Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week 8.

Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia disorder recruited from the community will be randomized to ZTEx training or SHE groups in a 1: 1 ratio.

Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and daytime impairment.

Interventions: Subjects in the ZTEx training group will attend two training lessons (2-hour each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will receive sleep hygiene education with the schedule and duration that are same to the ZTEx training group.

Main outcome measures: The primary outcome measure is the ISI score. Other measures include sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension. Acceptability and compliance of ZTEx will be evaluated.

Data Analysis: Differences in the questionnaire scores, subjective and objective sleep parameters will be examined using a mixed-effects model.

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Key information

Conditions

Insomnia, Primary Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, the Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults age 18-65 years old;
  • Chinese Hong Kong residents who are able to communicate in Cantonese or Mandarin;
  • A current clinical Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) diagnosis of insomnia disorder (Primary in nature) according to the Brief Insomnia Questionnaire (BIQ), a validated diagnostic tool. The criteria include having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months;
  • Insomnia Severity Index total score of at least 10 indicating insomnia at the clinical level;
  • Willing to give informed consent and comply with the trial protocol;
  • Ambulant and independent in activities of daily living;
  • Physically inactive which refers to less than 150 minutes moderate-intensity activity per week or less than 75 minutes vigorous-intensity activity per week, or an equivalent combination of moderate- and vigorous- intensity activity.

Exclusion criteria

  • Evidence of association of insomnia with medical conditions, other sleep disorders, or side-effects of medications;
  • Use of medication or psychotherapeutic components for insomnia or other psychiatric disorders;
  • Other possible psychiatric disorders including generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), psychosis as screened by structural clinical interview of DSM-IV;
  • cognitive impairment preventing informed consent or understanding of instructions (score < 22 in Montreal Cognitive Assessment Hong Kong version);
  • Shift work;
  • body mass index equal to or over 27.5, the obese criteria for Asians;
  • Unsafe conditions or incapable to exercise as recommended by their physician.

Treatment and study plan

Zero Time Exercise

Other

Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.

Sleep hygiene education

Other

We offer a 2-session education course to teach the subjects about sleep hygiene practice.

Primary outcomes

  1. Insomnia Severity Index

    Time frame: week 8

    The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point

Secondary outcomes

  1. Sleep diary (7-day)

    Time frame: Baseline, week 4, week 8

    The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated.

  2. Multidimensional fatigue inventory-20

    Time frame: Baseline, week 4, week 8

    Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.

  3. Hospital Anxiety and Depression Scale

    Time frame: Baseline, week 4, week 8

    The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, which assesses the severity of depressive and anxiety symptoms

  4. Actigraphy (7-day)

    Time frame: Baseline, week 8

    Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device

  5. Short Form-6 Dimension

    Time frame: Baseline, week 4, week 8

    The Short Form-6 Dimension is composed of six multi-level dimensions to assess the quality of life which can be used in cost-utility analysis.

  6. Hand grip strength

    Time frame: Baseline, week 8

    Objective hand grip strength

  7. Level of activity

    Time frame: Baseline, week4, week 8

    Self-report level of activity in moderate and vigorous intensity

  8. Weight

    Time frame: Baseline, week 8

    Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2)

  9. Height

    Time frame: Baseline, week 8

    Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2)

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 16, 2017
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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