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

NCT07789080 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2026-08-27

No results posted yet for this study

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.

Conditions

  • Loneliness
  • Social Isolation in Older Adults
  • Physical Inactivity
  • Healthy Ageing

Interventions

BEHAVIORAL

Supervised Group Exercise in Fitness Clubs

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.

BEHAVIORAL

Individual exercise

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.

Sponsors & Collaborators

  • SATS

    collaborator UNKNOWN
  • Oslo University Hospital

    collaborator OTHER
  • Norwegian School of Sport Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789080 on ClinicalTrials.gov