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

NCT07789080 | Recruiting

• 1 other identifier: 52300 850026-100
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Loneliness; Healthy Ageing; Socal isolation; Older adults

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and immediately after the 16-week intervention

Secondary Outcomes (12)

• 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

Study Arms (3)

Group exercise

EXPERIMENTAL

Participants will engage in supervised group exercise at SATS twice a week during daytime hours, for 16 weeks with sessions led by health and exercise physiologists from NIH. Participants will remain in the same exercise group throughout the intervention period and attend sessions led by the same instructors whenever possible. Instructors will foster a sense of belonging and community by learning participants' names, providing positive feedback, and explaining exercise benefits, thereby actively supporting relatedness and autonomy as conceptualised in SDT, embedded in the intervention. Following each session, a social meeting area with seating is available for informal post-exercise interaction, reflecting typical social spaces found in fitness club settings, where participants may choose to purchase refreshments.

Behavioral: Supervised Group Exercise in Fitness Clubs

PA Individually

EXPERIMENTAL

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.

Behavioral: Individual exercise

Control

NO INTERVENTION

Participants will be asked to continue with their everyday life. To minimize demotivation, the control group will be offered a 16-week membership to a local fitness club after the intervention period, including one supervised session. During the intervention period, participants will be contacted midway through the study to report their PA levels and sense of social connectedness. This design allows us to compare the intervention groups not only against each other, but also against a usual care condition, providing a clearer understanding of the added value of structured exercise and social participation beyond normal daily life.

Interventions

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.

Group exercise

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.

PA Individually

Eligibility Criteria

• Age: 75 Years - 100 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead
• SATS: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, Oslo, 0863, Norway

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Emilie Dalhaug

CONTACT

+ 47 91708426; emiliefm@nih.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized in a 1:1:1 ratio to one of three parallel groups: (1) supervised group exercise plus fitness club membership, (2) fitness club membership with independent exercise, or (3) a usual-life control group. The study is designed to compare the effects of structured group-based exercise and social participation with fitness club access alone and with no intervention.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)