Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia
Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia: A Pilot Randomized Controlled Trial
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Hong Kong、香港
- School of Nursing, The Hong Kong Polytechnic University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Zero Time Exercise training
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.
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ゼロ タイム エクササイズは、いつでもどこでもできる簡単な動きによって、人々に運動量を増やすよう促します。
ゼロタイム運動を行うために被験者を訓練するために、2セッションのトレーニングコースを提供しています。
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アクティブコンパレータ：sleep hygiene education
Subjects in this group will receive two 2-hour lessons of sleep hygiene education delivered by a registered nurse.
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睡眠衛生の実践について被験者に教えるために、2セッションの教育コースを提供しています。
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Insomnia Severity Index
時間枠：week 8
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The subjects rate the severity of insomnia, the distress, and the functional impairment associated with insomnia on a 5-point
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week 8
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sleep diary (7-day)
時間枠：Baseline, week 4, week 8
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The standardized sleep diary records the daily bedtime and rising time, from which the total time in bed (TIB) can be calculated.
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Baseline, week 4, week 8
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Multidimensional fatigue inventory-20
時間枠：Baseline, week 4, week 8
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Multidimensional fatigue inventory-20 is a 20-items self-report instrument designed to measure severity of fatigue.
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Baseline, week 4, week 8
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Hospital Anxiety and Depression Scale
時間枠：Baseline, week 4, week 8
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The Hospital Anxiety and Depression Scale is a 14-items self-administered questionnaire, which assesses the severity of depressive and anxiety symptoms
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Baseline, week 4, week 8
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Actigraphy (7-day)
時間枠：Baseline, week 8
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Actigraphy measures wrist movements to assess sleep or waking state, is accomplished through an accelerometer in a wrist worn device
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Baseline, week 8
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Short Form-6 Dimension
時間枠：Baseline, week 4, week 8
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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.
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Baseline, week 4, week 8
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Hand grip strength
時間枠：Baseline, week 8
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Objective hand grip strength
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Baseline, week 8
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Level of activity
時間枠：Baseline, week4, week 8
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Self-report level of activity in moderate and vigorous intensity
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Baseline, week4, week 8
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Weight
時間枠：Baseline, week 8
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Weight in kilograms; (Weight and Height will be combined to report as BMI in kg/m^2)
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Baseline, week 8
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Height
時間枠：Baseline, week 8
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Height in meters; (Weight and Height will be combined to report as BMI in kg/m^2)
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Baseline, week 8
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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