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Recruiting
NCT07789080
The ALIVE-Project: Activity, Life Satisfaction, Inclusion, Vitality, Elderly Women
Conditions: Loneliness, Social Isolation in Older Adults, Physical Inactivity, Healthy Ageing
Sex: Female
Ages: 75 Years – 100 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 213
Sponsor: Norwegian School of Sport Sciences
Location: Norwegian School of Sport Sciences Oslo Oslo
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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 \
Source: ClinicalTrials.gov (NCT07789080). StuddyBuddy aggregates publicly available trial information.