Prospective Study on Effects of a Healthy Lifestyle Program on Health Outcomes in Older Adults.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Change in sleep
研究概览
简要总结
Medical condition or disease under investigation : Quantitative and qualitative aspects of sleep, quality of life, functional ability and well-being in older adults (>55years)
Purpose of clinical trial : To study the prospective effects of a healthy lifestyle program on quantitative and qualitative aspects of sleep, quality of life, functional ability and well-being in older adults.
Primary objective : Measure the effects of the intervention on quantitative and qualitative aspects of sleep
Secondary objective (s) : Measure the effects of the intervention on physical activity, quality of life, functional ability and well-being Social identity and leadership, social support and motivation
Trial Design : Intervention study : controlled before-and-after study
Sample Size : total sample size : 1.000 participants
Summary of eligibility criteria : Older adults aged above 55years
Included in intervention group : adults who are participating in the healthy lifestyle promotion program 'Lekker Actief', organized by OKRA
Included in control group : waitlist controls or controls (adults, members of OKRA, not participating in the health promotion program 'Lekker Actief')
Maximum duration of treatment of a subject :
- Start of Health promotion program 'Lekker Actief' : September 2018
- Measurements with accelerometers will start prior to the health promotion program 'Lekker Actief' : July 2018
- End of Health promotion program 'Lekker Actief' : December 2019
- Duration of Health promotion program 'Lekker Actief': 12 weeks
- Maximal duration : July 2018-December 2019
详细描述
This trial will consist of 3 visits : Pretest and posttest.
- Pretest measurements (week 0)
o Accelerometry : a subsample of participants form intervention and control groups (n=400) will be asked to wear an accelerometer (type GT3X) during 7 entire days prior to baseline measurements. (Timing : July 2018-July 2019)
o Baseline measurements : during the start up moment of the program all participants from intervention and control groups will be asked : (Timing : July 2018-July 2019)
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To fill out the self-reported questionnaire (survey) : the survey is composed of existing validated scales : IPAQ, PSQI, SF-12, WEMWBS, HAQ-DI. (references of validated scales are provided in the 'outcome measures' section)
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To perform a walk test over 20 meters in order to determine the individual stride length
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To perform a 6 minute walking test in order to self-report perceived exertion and physical fitness (by Borg Scale) and to determine the individual entry level of the program (entry levels vary between 1-12)
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To wear the Pedometer (Omron® Walking Style one 2.0) on a daily basis and register the amount of daily steps in their personal registration forms
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Posttest measurements (week 12)
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Accelerometry : a subsample of participants form intervention and control groups (n=400) will be asked to wear an accelerometer (type GT3X®) during 7 days prior to posttest measurements. (Timing : September 2018 - December 2019)
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Posttest measurements : at the end of the program all participants will be asked :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 55+ years
排除标准
- •Participants who are physically unable to participate in weekly meetings (PAR-Q : Physical activity readiness scale) (Thomas et al., 1992)
结局指标
主要结局
Change in sleep
时间窗: Pretest (week 0), posttest (week 12) and follow up (month 15)
Change in quantity of sleep : measured in minutes and hours by accelerometry and self-reported questionnaires (PSQI : Pittsburgh Sleep Quality Index (PSQI)) Change in quality of sleep : measured by self-reported questionnaire (PSQI)
次要结局
- Change in objectively perceived physical activity(Pretest (week 0), posttest (week 12) follow up (month 15))
- Change in subjectively perceived physical activity(Pretest (week 0), posttest (week 12) follow up (month 15))
- change in quality of life(Pretest (week 0), posttest (week 12) follow up (month 15))
- change in functional ability(Pretest (week 0), posttest (week 12) follow up (month 15))
- change in wellbeing(Pretest (week 0), posttest (week 12) follow up (month 15))
- Social identity and leadership(Pretest (week 0), posttest (week 12))
- motivation(Pretest (week 0), posttest (week 12))
- Social support(Pretest (week 0), posttest (week 12))
研究者
Julie Vanderlinden
Principal Investigator
KU Leuven