NCT02051725已完成不适用
Implementation of an "Active Life-style" Intervention in Older People With Low Physical Function: Effect on Functional Impairments, Pilot
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Changes in leg press muscle power
研究概览
简要总结
- Aging is associated with a progressive and generalized deterioration of physiologic systems and greater incidence of chronic conditions, which ultimately translates into functional impairment, disability and dependency.
- Physical activity and exercise have been recognized as key pillars for the management of chronic diseases in support of medical treatment, and essential to increase physiologic function, but there is only limited evidence indicating increased physical function, following exercise interventions. One of the greatest challenges in the science of aging and exercise is to understand whether and to which extent exercise and active life-style may postpone the onset of disability and/or reverse physical impairments.
- Maintenance/improvements of physical function and mobility should be considered as primary targets for independent living, active engagement in societal challenges, and, more in general, when promoting "active ageing".
- The aim of this study is to collect preliminary data to identify the feasibility and sustainability of an "active life-style intervention" in older adults with reduced mobility receiving a preventive home visit from the public health care authority.
- This study will represent the base for a larger phase III parallel group study implemented in the public health care setting, with the specific aim of improving physical function and delay the onset of functional impairment in older adults.
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
- 76 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older adults (age 76 years and above) receiving a visit from the personnel of preventive home unit of municipality of Odense (DK)
- •Mini Mental State Examination > = 21
- •Self-selected gait speed < 0,9 m/s
- •Ability to self-transport to the training facility
排除标准
- •Unstable medical conditions including ECG abnormalities, uncontrolled hypertension, terminal and critical chronic conditions (e.g. cancer, severe heart failure)
- •Amputation or other severe physical impairments prohibiting participation in the active life-style intervention
- •Refusal to wear accelerometer
结局指标
主要结局
Changes in leg press muscle power
时间窗: Changes in muscle power from baseline to 12-week follow up
Muscle power will be assessed on the dominant leg with the Notthingham power rig and expressed as Watt/kg. Subjects are sitting with
次要结局
- Physical activity, sedentary behaviour and sleep quality (objectively assessed by accelerometry)(Changes from baseline to 12-week follow up)
- Cognitive function (Mini Mental State Examination and Digit Symbol Substitution Test)(Changes from baseline to 12-week follow up)
- Self-report Health-related measures including quality of life, pain, depression, sleep quality, fatigue, activities of daily living, anxiety.(Changes from baseline to 12-week follow up)
- Body composition including muscle, fat and bone quantity and quality(Changes from baseline to 12-week follow up)
- Neuromuscular function including strength, power, explosive force, postural control, motor/sensor nerve function(Changes from baseline to 12-week follow up)
- Selected blood biomarkers related to physical, muscle-skeletal and cognitive function (e.g. C reactive protein, insulin like growth factor, IL-6, BDNF)(Changes from baseline to 12-week follow up)
- Physical function including short and long distance walking speed, stair climbing, Short Physical Performance Battery Test(Changes from baseline to 12-week follow up)
研究者
Paolo Caserotti
Assistant Professor
University of Southern Denmark
研究点 (2)
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