The ALIVE-Project: Activity, Life Satisfaction, Inclusion, Vitality, Elderly Women

ConditionsLoneliness Social Isolation in Older Adults Physical Inactivity Healthy Ageing

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age75-100

SponsorNorwegian School of Sport Sciences

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Supervised Group Exercise in Fitness Clubs
Behavioral
Participants assigned to this intervention will receive a 16-week supervised group exercise program delivered in fitness clubs. Exercise sessions will be conducted twice weekly in stable groups of approximately 8 to 15 participants and led by trained health and exercise professionals. Each 60-minute session includes warm-up, aerobic and resistance exercises, functional circuit training, balance exercises, and cool-down. Participants will also have opportunities for informal social interaction with fellow participants following each session. The intervention is designed to combine regular physical activity with structured social participation in order to promote social connectedness, well-being, and physical health in older women.
Individual exercise
Behavioral
Participants will receive a 16-week membership to a different SATS fitness club in the same district, which includes access to advanced cardio and resistance equipment, but without the group-based exercises. They will be given one supervised session to learn how to use the equipment. This group represents access to a community exercise arena without structured social facilitation through group-based exercise classes, thereby allowing examination of whether access alone is sufficient, or whether structured social participation is necessary for improved mental and physical health. Importantly, this comparison enables evaluation of the added value of structured social participation beyond access to exercise facilities alone. It also allows us to explore whether simply leaving the home environment and being exposed to a social setting may in itself contribute to improved quality of life.

Treatment groups

213 Participants

are divided into 3 treatment groups

Group A: Group exerciseExperimental treatment 1 intervention

Group B: PA IndividuallyExperimental treatment 1 intervention

Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Loneliness and socal isolation

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).

Time frame