The ALIVE-Project: Activity, Life Satisfaction, Inclusion, Vitality, Elderly Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Loneliness and socal isolation
研究概览
简要总结
Many older women live alone and may experience loneliness, reduced social participation, and declining physical health. Regular physical activity can improve health and independence, but it is not known whether exercising in a supervised group setting provides additional social and psychological benefits compared with exercising independently.
The ALIVE study is a 16-week randomized controlled trial that will investigate the effects of fitness club participation on loneliness, social connectedness, quality of life, mental health, physical activity, and physical fitness in women aged 75 years and older who live alone and are insufficiently physically active. Participants will be randomly assigned to one of three groups: (1) supervised group exercise at a fitness club combined with opportunities for social interaction, (2) fitness club membership with independent exercise, or (3) a control group continuing their usual daily activities.
A total of 213 women will be recruited from Oslo, Norway. Outcomes will be assessed before and after the intervention using questionnaires, physical performance tests, body composition measurements, cardiovascular risk assessments, and device-based measurement of physical activity. In addition, qualitative interviews will be conducted to explore participants' experiences, barriers, facilitators, and perceptions of social connection and belonging.
The study aims to determine whether supervised group exercise in fitness clubs can reduce loneliness and improve health and well-being among older women, while generating knowledge about practical community-based strategies to support healthy and socially connected ageing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 75 Years 至 100 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged ≥75 years
- •Currently living alone for at least four months (including widowed or single women)
- •Residing at home in Oslo with convenient access to participating SATS fitness clubs in the Nordre Aker or Vestre Aker districts
- •Participating in <60 minutes per week of planned, structured exercise at moderate-to-vigorous intensity, whether individually or in an organized setting (excluding recreational walking and other habitual physical activity)
排除标准
- •Dementia or other cognitive impairment
- •Diseases that are contraindicated for exercise or testing (such as unstable angina, recent heart attack, uncontrolled arrhythmia, or recent coronary bypass surgery)
结局指标
主要结局
Loneliness and socal isolation
时间窗: Baseline and immediately after the 16-week intervention
The Revised UCLA Loneliness Scale-6 (RULS-6) will be used to assess subjective feelings of loneliness and social isolation. The instrument consists of 6 items evaluated on a 4-point Likert scale. Individual item scores are summed to produce a single total score.The scale has a minimum value of 6 and a maximum value of 24. A higher total score on the RULS-6 indicates a worse outcome, representing a higher degree of perceived loneliness and social alienation. Conversely, lower scores represent a better outcome (greater social connectedness).
次要结局
- Health-related quality of life(Baseline and immediately after the 16-week intervention)
- Depression and anxiety(Baseline and immediately after the 16-week intervention)
- Functional independence(Baseline and immediately after the 16-week intervention)
- Musculoskeletal complaints(Baseline and immediately after the 16-week intervention)
- Urinary incontinence(Baseline and immediately after the 16-week intervention)
- Endurance(Baseline and immediately after the 16-week intervention)
- Lower-body muscle strength and functional mobility(Baseline and immediately after the 16-week intervention)
- Hand grip strength(Baseline and immediately after the 16-week intervention)
- Balance and postural stabilit(Baseline and immediately after the 16-week intervention)
- Body composition(Baseline and immediately after the 16-week intervention)
- Metabolic biomarkers(Baseline and immediately after the 16-week intervention)
- Device-measured physical activity(Baseline and immediately after the 16-week intervention)
研究者
Lene A. H. Haakstad
Professor
Norwegian School of Sport Sciences