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临床试验/NCT02553980
NCT02553980已完成不适用

Development and Dissemination of an Online Exercise and Health Promotion Program for Hong Kong Middle-aged Chinese: The Virtual Trainer System 3rd Version

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 261 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
261
试验地点
1
主要终点
Changes of physical activity level as measures by accelerometer and International Physical Activity Questionnaire

研究概览

简要总结

Practicing a habitual physical activity is important for health. A Virtual Trainer (VT) online system was developed in 2006 (1st version) and improved in 2010 (2nd version) for encouraging an active lifestyle. This project intends to further improve the VT (3rd version) which incorporates more effective psychological and e-health theories, and disseminate it to Hong Kong middle-aged adults.

详细描述

Hong Kong is a highly urbanized city that many people work long hours daily and over the week, especially for those middle-aged adults. The limited time and lack of professional exercise instruction are always the barriers for them to participate in physical activity (PA). With the advances in information technology (IT), the knowledge of PA can be rapidly disseminated through the Internet and smartphone. We design an IT- instruction based lifestyle intervention program, with the purpose to improve PA level and health status in a sample of middle-aged Hong Kong adults. A two-arm parallel individual level randomized controlled trial (RCT) named "Follow Your Virtual Trainer (FYVT)" will be conducted among 200 healthy and sedentary Chinese adults aged from 40 to 65 years. The participants will be randomly allocated into intervention group or control group. Those in intervention group will under the instruction of a web-based computer software termed "Virtual Trainer", which interact with their smartphone apps, to conduct a 3-month self-planned PA training program. A serious of online video seminars with healthy lifestyle themes will be released to the participants biweekly among 3 months. After that, 6 months observation will be followed. Those in control group will only receive a written advice of standard PA recommendation, and the textual content of the seminars. The assessments will be implemented at baseline, 3, 6, and 9 month. Primary outcome is PA measured by accelerometer and International Physical Activity Questionnaire; the second outcomes include cardio-respiratory fitness, resting energy expenditure, anthropometrics, body composition, blood pressure, health-related quality of life, sleep quality and quantity, fatigue, behavior mediators, and maintenance of PA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

randomly assigned into either treatment 1, treatment 2, or control. All participants were managed in individual basis, hence no interaction between any participants was guaranteed. Participants were informed only their treatment without knowing the existence of other treatment.

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 40 to 65 years
  • able to understand Cantonese and read Chinese
  • self-reported inactivity (no habitual exercise experience for at least 6 months)
  • the baseline resting energy expenditure (REE) is less than 1.05 kcal•min-1 for men and 0.85 kcal•min-1 for women
  • reachable by telephone
  • have basic computer skills
  • have smartphone and always surf internet (at least 4 times per week)
  • will not leave Hong Kong for a long time (longer than 2 months) during the study period

排除标准

  • self-reported history of cardiovascular and pulmonary diseases, neurological disorder, musculo-skeletal disorder, and osteoarthritis
  • receiving medically prescribed diet or PA intervention
  • blood pressure ≥ 160/100 mmHg
  • using of medication that may influence exercise performance
  • for women, currently pregnant or plan to become pregnant in the next 1 years, and those receiving hormonal therapy

研究组 & 干预措施

Physical activity promotion I

Experimental

Participants in this group attended the "VT3" program (with Automatic HR detection)

干预措施: Follow Your Virtual Trainer (FYVT) program (Behavioral)

Physical activity promotion II

Experimental

Participants in this group attended the "VT2" program (self PA report)

干预措施: Follow Your Virtual Trainer (FYVT) program (Behavioral)

Control

Placebo Comparator

Participants in this group did not receive any VT treatment, and live as usual.

干预措施: Daily PA recommendation & healthy lifestyle suggestions (Other)

结局指标

主要结局

Changes of physical activity level as measures by accelerometer and International Physical Activity Questionnaire

时间窗: Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months

次要结局

  • Changes of body weight as measured by weighting scale(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of hip circumference as measured by standardized tape measure(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of sleep quality as measured by the Pittsburgh Sleep Quality Index(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of cardio-respiratory fitness as measured by the symptom limited maximal treadmill exercise test using the metabolic analyzer (Cosmed K4b2, Italy)(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of resting kilocalorie expenditure (KCal in KCal•min-1) as measured by the metabolic analyzer (Cosmed K4b2, Italy)(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of resting heart rate (HR in beats•min-1) as measured by heart rate monitor(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of waist circumference as measured by standardized tape measure(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of resting VO2 (ml•min-1•kg-1) as measured by the metabolic analyzer (Cosmed K4b2, Italy)(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of body mass index (BMI) as measured by the calculation of weight (kg) divided by the square of height (cm)(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of body mass as measured by the bioelectrical impedance analysis (Tanita, BC 581, Japan)(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of blood pressure as measured by the mercury sphygmomanometer(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of self-perceived fatigue as measured by the Numeric Rating Scale (NRS)-fatigue(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of body fat percentage as measured by the bioelectrical impedance analysis (Tanita, BC 581, Japan)(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of waist hip ratio (WHR) as measured by the calculation of dividing the waist circumference (cm) by the hip circumference (cm)(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of health-related quality of life as measured by the SF-36(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Changes of sleep quantity as measured by a 7-day Daily Sleep Log(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)
  • Maintenance of physical activity as measured a self-administered questionnaire(Measures will be done at two time points: 6 months and 9 months)
  • Behavior mediators as measured by a self-administered questionnaire(Measures will be done at four time points: baseline, 3 months, 6 months, and 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stanley Sai-Chuen Hui

Professor

Chinese University of Hong Kong

研究点 (1)

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