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

NCT03155750 | Completed

• 1 other identifier: ZTEInsomnia
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia, Primary

Keywords

insomnia

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

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

  week 8

Secondary Outcomes (9)

• Sleep diary (7-day)

  Baseline, week 4, week 8

• Multidimensional fatigue inventory-20

  Baseline, week 4, week 8

• Hospital Anxiety and Depression Scale

  Baseline, week 4, week 8

• Actigraphy (7-day)

  Baseline, week 8

• Short Form-6 Dimension

  Baseline, week 4, week 8

Study Arms (2)

Zero Time Exercise training

EXPERIMENTAL

Subjects in this group will attend two 2-hour ZTEx training lessons. Each subject will receive a handout and an exercise log. The handout includes a picture-illustrating ZTEx step-by-step protocol. The exercise log is for them to record their time spending on performing the ZTEx every day during the 8-week study period.

Other: Zero Time Exercise

sleep hygiene education

ACTIVE COMPARATOR

Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse.

Other: Sleep hygiene education

Interventions

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.

Zero Time Exercise training

Sleep hygiene education OTHER

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

sleep hygiene education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• Yeung WF, Lai AY, Ho FY, Suen LK, Chung KF, Ho JY, Ho LM, Yu BY, Chan LY, Lam TH. Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. Sleep Med. 2018 Dec;52:118-127. doi: 10.1016/j.sleep.2018.07.025. Epub 2018 Aug 24.

  PMID: 30312957 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 16, 2017
• Study Start: June 5, 2017
• Primary Completion: September 7, 2017
• Study Completion: September 7, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)