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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hong Kong, 홍콩
- School of Nursing, The Hong Kong Polytechnic University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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Zero Time Exercise는 언제 어디서나 할 수 있는 간단한 움직임으로 신체 운동을 늘리도록 권장합니다.
제로타임 운동을 할 수 있도록 2회기 교육과정을 제공합니다.
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활성 비교기: 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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2회기 교육과정을 통해 수면위생실천에 대해 교육합니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Insomnia Severity Index
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Sleep diary (7-day)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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