Comparison of a Group-delivered and Individually Delivered Lifestyle-integrated Functional Exercise (LiFE) Program in Older Persons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 4
- 主要终点
- Fall incidence expressed as number of falls per amount of physical activity
研究概览
简要总结
In the Lifestyle-Integrated Functional Exercise (LiFE) program, exercises to increase strength and improve balance are embedded into daily life activities. Recurring daily activities and tasks are used as prompts for these exercises so that they are performed multiple times per day. However, implementing the original LiFE program includes high financial requirements and human resources as it comprises one-to-one supervision of participants. Therefore, it is investigated whether implementing LiFE in groups (gLiFE) is not inferior to the individually delivered LiFE (iLiFE) in terms of reducing falls per physical activity. In addition, gLiFE is expected to be more cost-effective as compared to iLiFE. In a multicenter non-inferiority trial, 300 participants aged 70 years or older with confirmed fall risk will be randomized into either the iLiFE or gLiFE arm of the study. Both arms will undergo the same strength and balance exercises and habitualization strategies as described in the LiFE program, however, based on different approaches of delivery (i.e., group vs. individual).
详细描述
The "Lifestyle-integrated Functional Exercise" (LiFE) program aims to promote safe indoor and outdoor mobility. It differs from classical exercise programs in that it trains and encourages participants to embed up to 15 balance and strength exercises into daily recurring tasks performed as part of the daily life routine. The LiFE program simultaneously aims at preventing falls and promoting an active lifestyle in older adults. As LiFE requires 1:1 supervision by trainers who administer LiFE exercises during seven visits in the participants' homes, it is both time consuming and resource intensive and therefore not suitable for widespread implementation. Hence, the aim of this study is to compare a group-delivered LiFE intervention (gLiFE) with the original LiFE intervention (iLiFE). More specifically, gLiFE is tested for its non-inferiority compared to iLiFE in terms of:
- Effectiveness: The gLiFE program is not less efficacious than the established iLiFE program in terms of reducing fall incidence expressed as number of falls per amount of physical activity (e.g., steps).
- Retention rate: The gLiFE program does not result in a lower intervention retention rate (i.e., percentage of the sample completing the 6-month and 12-month follow-up assessment) as compared to the iLiFE program.
- Implementation: Delivering the gLiFE program is less costly and more cost-effective than delivering the iLiFE program.
In a multicenter non-inferiority trial, participants (n = 300; > 70 years; confirmed fall or high risk of falling) will be randomized into either the individual iLiFE (seven home visits) or gLiFE (groups up to twelve persons; seven group sessions).
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)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 70 years or older
- •Speaks German language
- •Able to read newspaper
- •Able to walk 200 meters with or without walking aid
- •Home-dwelling
- •Two or more falls in the past 12 months OR one injurious fall in the past 12 months OR subjective decline in balance and strength in the past 12 months together with Timed Up-and-Go time >13.5 seconds
- •Available for intervention participation for 11 weeks
排除标准
- •Cognitive impairment (MoCA <23)
- •Current participation in an organised exercise class >1 per week in the past 3 months
- •Moderate to vigorous-intensity physical activity ≥150 min/week in the past 3 months
- •Medical conditions:
- •Heart failure New York Heart Function Assessment (NYHA) class III and IV
- •Recent cerebrovascular accident (<6 months)
- •Parkinson's disease
- •On active cancer treatment (last 6 months)
- •Chronic Obstructive Pulmonary Disease (COPD) Gold class III and IV
- •Unstable lower limb fracture
- •Amputated lower extremity (-ies)
- •Acute treatment of depression
- •Uncontrolled resting blood pressures of a systolic >160 or diastolic >100 or higher
结局指标
主要结局
Fall incidence expressed as number of falls per amount of physical activity
时间窗: Change; baseline, 6 months, 12 months
Falls are assessed using a fall calendar; Physical activity is assessed using activPAL accelerometers
Cost-effectiveness of iLiFE and gLiFE
时间窗: Change; baseline, 6 months, 12 months
Incremental Cost-Effectiveness Ratios (ICERs) of delivering iLiFE and gLiFE
次要结局
- Social support(Change; baseline, 6 months, 12 months)
- Cognitive status(Change; baseline, 6 months, 12 months)
- Handgrip strength(Change; baseline, 6 months, 12 months)
- Fear of falling(Change; baseline, 6 months, 12 months)
- Accelerometer-collected physical activity (duration)(Change; baseline, 6 months, 12 months)
- Accelerometer-collected physical activity (intensity)(Change; baseline, 6 months, 12 months)
- Health status (b)(Change; baseline, 6 months, 12 months)
- Static balance (a)(Change; baseline, 6 months, 12 months)
- Gait speed(Change; baseline, 6 months, 12 months)
- Accelerometer-collected physical activity (percentage)(Change; baseline, 6 months, 12 months)
- Adherence to LiFE activities(Monthly; starting from first iLiFE or gLiFE participation until the date of the 12 month follow-up)
- Self-reported function and disability(Change; baseline, 6 months, 12 months)
- Static balance (b)(Change; baseline, 6 months, 12 months)
- Functional leg strength (a)(Change; baseline, 6 months, 12 months)
- Motivational quality(Change; baseline, 12 months)
- Health Action Process Approach (HAPA) - IAC(Change; baseline, 6 months, 12 months)
- Group cohesion(Change; baseline, 6 months, 12 months)
- Functional leg strength (b)(Change; baseline, 6 months, 12 months)
- Balance confidence(Change; baseline, 6 months, 12 months)
- Health status (a)(Change; baseline, 6 months, 12 months)
- Depressive Symptoms(Change; baseline, 6 months, 12 months)
- Subjective age(Change; baseline, 6 months, 12 months)
- Habit strength(Change; baseline, 6 months, 12 months)
- Health Action Process Approach (HAPA) - SE(Change; baseline, 6 months, 12 months)
- Health Action Process Approach (HAPA) - ACP(Change; baseline, 6 months, 12 months)
- Evaluation of the LiFE program(Change; after the last intervention session, 6 months, 12 months)
- Health-related resource use(Change; baseline, 6 months, 12 months)
- Health Action Process Approach (HAPA) - Int(Change; baseline, 6 months, 12 months)
研究者
Carl-Philipp Jansen
Post-Doctoral Research Assistant
Heidelberg University