The PreventIT Feasibility Randomised Controlled Trial in Young Older Adults, Comparing Two Lifestyle-integrated Exercise Interventions Delivered by Use of ICT or an Instructor, With a Control Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Self-reported function and disability
研究概览
简要总结
The feasibility randomised controlled trial is part of the EU funded project "PreventIT" (2016-2018) responding to the Horizon 2020, Personalised health and care (PHC), call PHC-21: Advancing active and healthy ageing with ICT: Early risk detection and intervention. The PreventIT project focuses on a new behaviour change activity approach for young older adults (61-70 years of age) with an overall aim of early prevention of functional decline and to empower people to take care of their own health.
详细描述
In this feasibility randomised controlled trial two interventions are compared with a control group. The aLiFE programme includes instructor and paper manual delivery of life-style integrated activities, while the eLiFE programme delivers the same activities by use of smartphone and smartwatch applications. The control group is asked to follow the World Health Organisation's physical activity recommendations.
The main aim is to assess feasibility of the aLiFE and eLiFE programmes and a second aim to suggest sample size and design for a future Phase III clinical trial.
OBJECTIVES: How is the feasibility of having young older adults (between 61-70 years) to perform the aLiFE and eLiFE interventions.
Specifically:
- Participation: How is the adherence of specific activities and to the entire aLiFE and eLiFE interventions of young older adults?
- Technology: How is the feasibility and usability of the eLiFE intervention delivered using smartphones and smartwatches as platform, regarding user interface, goal setting, feedback, motivational messages, and social interaction?
- Outcome measures: How is the risk reduction of functional decline, measured by the Later Life Function and Disability Instrument and behavioural complexity, for the aLiFE and the eLiFE interventions compared to a control group, and what are the estimates of effect sizes for the primary and secondary study outcome measure?
- Health economics evaluation: Is it feasible to collect data on, and estimate, health care resource utilization, costs and quality-adjusted life years (QALYs), and model incremental cost-effectiveness ratios (ICERs) of aLiFE, eLiFE compared with the control group over a 6-month, 12-month, and 24-month time horizon?
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 (Outcomes Assessor)
盲法说明
Assessors are blinded to group allocation
入排标准
- 年龄范围
- 61 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born in the years 1947-1956
- •Retired (more than 6 months, <50% paid/unpaid work)
- •Home-dwelling
- •Able to read newspaper or text on smartphone
- •Speak Norwegian/Dutch/German
- •Able to walk 500 m without walking aids
- •Available for home visits the following 6 weeks
- •Defined "at risk" for functional decline by the risk screening instrument developed in the PreventIT project
排除标准
- •Current participation in an organised exercise class >1 per week or moderate-intensity physical activity ≥150 min/week in the previous 3 months
- •Travels planned >2mths during follow-up
- •Cognitive impairment (MOCA <24 points)
- •Medical conditions:
- •Heart failure New York Heart Function Assessment (NYHA) class III and IV
- •Acute myocardial infarction last 6 months or unstable angina
- •Pericarditis, myocarditis, endocarditis in the last 6 months
- •Symptomatic aortic stenosis
- •Cardiomyopathy
- •Resting blood pressures of a systolic >180 or diastolic >100 or higher
- •Chronic Obstructive Pulmonary Disease (COPD) Gold class III and IV
- •Uncontrolled Asthma (at least 2 exacerbation in the last 6 months)
- •Amputated lower extremities
- •On active cancer treatment during last 6 months
- •Ankylosing spondylitis
- •History of schizophrenia
- •Parkinsons disease
- •Recently diagnosed Cerebrovascular Accident (<6 months)
- •Epilepsy (treated with medication)
- •Severe rheumatic arthritis interfering with mobility
- •Fracture of lumbar spine / thoracic spine or lower extremity in the last 6 months
- •3 fractures in the last 2 years due to severe osteoporosis
研究组 & 干预措施
aLiFE
The aLiFE programme is developed for young older adults, where balance activities, strengthening activities, and specific recommendations for increasing physical activity, are embedded within everyday activities, so that the activities can be performed multiple times throughout the day. The programme is presented by an instructor by use of a paper based manual during a 6 month intervention period in participants homes.
干预措施: aLIFE (Behavioral)
eLiFE
The aLiFE programme is transferred to a mobile health system, called the eLiFE. The intervention is delivered on smartphones and smartwatches including inertial sensors well suited to monitor physical activity and movement quality in daily life. An instructor teaches the participants how to use the mobile health system during home visits and phone calls during the 6 month intervention period. A virtual instructor teaches the participants the eLiFE programme. Pictures and videos of the aLiFE activities are delivered by use of the system. Behavioural change strategies are also included in the system.
干预措施: eLIFE (Behavioral)
control
The control group follows the World Health Organization's recommendations of physical activity.
干预措施: control (Behavioral)
结局指标
主要结局
Self-reported function and disability
时间窗: Change; baseline, 6 months and 12 months
Measured using the Late-Life Function and Disability Instrument (LLFDI)
Behavioural complexity metric
时间窗: Change; baseline, 6 months and 12 months
A composite measure of physical activity, sleep, and social participation, measured by a unitless scale. Physical activity and sleep is objectively measured by activity monitors worn at the lower back and the wrist, while social interaction is assessed as phone calls.
次要结局
- Balance and mobility(Change; baseline, 6 months and 12 months)
- Static balance(Change; baseline, 6 months and 12 months)
- Gait speed(Change; baseline, 6 months and 12 months)
- Grip Strength(Change; baseline, 6 months and 12 months)
- Functional Leg Strength(Change; baseline, 6 months and 12 months)
- Mood(Change; baseline, 6 months and 12 months)
- Fear of falling(Change; baseline, 6 months and 12 months)
- Instrumented standing balance(Change; baseline, 6 months and 12 months)
- Instrumented mobility(Change; baseline, 6 months and 12 months)
- Number of participants completing the different parts of the study(Screening, baseline, 6 months, and 12 months follow up)
- Attendance and adherence intervention(From date of first home visit until the date of the 12 month follow-up, assessed up to 12 months)
- Cost-effectiveness(Baseline, 6 months, and 12 month follow up)
- Accelerometer Collected duration of sedentary time during 7 days(Change; baseline, 6 months and 12 months)
- Accelerometer Collected percentages of walking time during 7 days(Change; baseline, 6 months and 12 months)
- Accelerometer Collected duration of walking time during 7 days(Change; baseline, 6 months and 12 months)
- Cognitive function(Change; baseline, 6 months and 12 months)
- Instrumented functional strength(Change; baseline, 6 months and 12 months)
- Adverse Events(Through study completion, an average of 12 months)
- Process evaluation(12 months)
- Accelerometer Collected percentages of sedentary time during 7 days(Change; baseline, 6 months and 12 months)
- Accelerometer Collected intensity (metabolic equivalent) of walking time during 7 days(Change; baseline, 6 months and 12 months)
- Accelerometer Collected duration of active time during 7 days(Change; baseline, 6 months and 12 months)
- Technology evaluation(6 months and 12 month follow up)
- Acceptance of self-administered tests(Baseline and 12 month follow up)
- Accelerometer Collected intensity (metabolic equivalent) of sedentary time during 7 days(Change; baseline, 6 months and 12 months)
- Accelerometer Collected percentages of active time during 7 days(Change; baseline, 6 months and 12 months)
- Accelerometer Collected intensity (metabolic equivalent) of active time during 7 days(Change; baseline, 6 months and 12 months)
- Health related quality of life(Change; baseline, 6 months and 12 months)
- Experience with the interventions, including motivation and behaviour change(Baseline, 6 months, and 12 month follow up)
- Quality Adjusted Life Years (QALYs)(Baseline, 6 months, and 12 month follow up)