Tailored Exercise and Behavioural Intervention to Modify Risk Factors Associated With Loss of Physical Function and Disability in Older Adults: Results From the Community-based Welfare Innovation in Primary Prevention Project (WIPP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- Change in physical function
研究概览
简要总结
The aim of this study is to compare the effect of 12 weeks group-based exercise program enhanced with 24 weeks health empowerment program (HEP) to an extended usual care condition (the HEP program alone) on physical function, disability, health-related quality of life (HQoL) in home-dwelling older adults at risk for disability. Interventions were implemented into existing health care pathways and added to routine preventive programs using a two-armed randomized intervention design with multiple sites.
详细描述
Study design: a two-armed multi-faceted exercise intervention study with two phases: 12 weeks intensive phase followed by 12 weeks maintenance phase.
Intensive phase
- Active condition (exercise + health-empowerment): twice-weekly exercise + 4 health-empowerment sessions
- Comparison condition (health-empowerment) 8 health-empowerment sessions
Maintenance phase
- Active condition (exercise + health-empowerment): 4 health-empowerment sessions
- Comparison condition (health-empowerment): 4 health-empowerment sessions
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects were eligible if at least one of following criteria was met:
- •Reduced physical function: SPPB score ≤9
- •Fatigability: Pittsburg Fatigability score of 15 or above (≥15)*
- •Low physical activity: Physically active ≤1day per week while sitting ≥8 hours on a normal day
- •Falls: ≥2 fall over the past year
- •Have pain: Brief Pain Inventory interference score ≥20
排除标准
- •High functioning (Composite SPPB score >10)
- •Too physically active (Physically active ≥3 days/week while sitting down <5 hours during a normal day)
- •Deadly or critical illness (Cancer, severe heart failure)
- •Recent surgery that is expected to affect the intensity of exercise and limit activity#
- •Recent fractures that is expected to affect the intensity of exercise and limit activity#
- •Chronic pain that prevents regular exercise
- •Reduced cognitive function (Dementia, Alzheimer's)
- •If the subject has completed a rehabilitation process in relation with an operation or fracture, the citizen is free to attend.
- •Additional precautions:
- •Indication of reduced cognitive function: When Six-Item Cognitive Impairment Screener score <4, subjects are referred to experts for further assessment and determination of cognitive function.
- •When unintended weight loss and underweight is detected by the nutritional assessment scheme (score =2), citizens are referred to medical doctor or dietician to recover this, prior to being enrolled in the study.
结局指标
主要结局
Change in physical function
时间窗: The SPPB is assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase)
Physical function was assessed by the Short Physical Performance Battery (SPPB). The SPPB consists of three objective physical function tests: balance, gait and chair-rise. Sub-scores: Balance test, range 0-4 points: 1. Feet in parallel position (0-9.99 sec = 0 point; ≥10 sec = 1 point) Unable: 0 points: balance test stops 2. Feet in semi-tandem position (0-9.99 sec = 0 point; ≥10 sec = +1 point) Unable: balance test stops 3. Feet in tandem position (3 to 9.99 sec = +1 point, ≥10 sec = +2 point) Gait test, range 0-4 points: Time to walk 3 meters in normal pace * \<3.62 (4 points) * 3.62 to 4.65 seconds (3 points) * 4.66 to 6.52 seconds (2 points) * \>6.52 seconds (1 point) * Unable (0 points) Chair stand test: 5 repetitions from seated to standing position with arms across chest. * ≤11.19 seconds (4 points) * 11.20 to 13.69 seconds (3 points) * 13.70 to 16.69 seconds (2 points) * 16.70 seconds (1 point) * Unable (0 points) The composite SPPB score ranges from
次要结局
- Participation in new community or health activities, after intervention phase 2(Assessed at week 24 (after the maintenance phase))
- Change in outcome expectations for Exercise(Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase))
- Change of management of perceived barriers for exercise(Assessed at week 12 (after the intensive phase) and week 24 (after the maintenance phase))
- Change in self-efficacy for exercise Exercise(Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase))
- Change in self-reported physical function and disability(Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase))
- Change in health related quality of life(Assessed at week 0 (baseline), week 12 (after the intensive phase) and week 24 (after the maintenance phase))
- Change in perceived barriers for exercise(Assessed at week 12 (after the intensive phase) and week 24 (after the maintenance phase))
- Participation in new community or health activities, after intervention phase 1(Assessed at week 12 (after the intensive phase))