An interventional study of Supervised Group Exercise in Fitness Clubs and Individual exercise in Loneliness, Social Isolation in Older Adults and Physical Inactivity, sponsored by Norwegian School of Sport Sciences. Recruiting at 1 site in Norway. Open to female participants aged 75 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Norwegian School of Sport Sciences · Not applicable, Interventional, and Basic science
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.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 213 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
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Exclusion Criteria:
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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
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
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.
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.
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.
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: Baseline and immediately after the 16-week intervention
Health-related quality of life
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) assesses health-related quality of life. The items are scored and transformed into standardized domain scores. Each scale has a minimum value of 0 and a maximum value of 100. A higher score indicates a better outcome (better health and higher quality of life)
Time frame: Baseline and immediately after the 16-week intervention
Depression and anxiety
The Hospital Anxiety and Depression Scale (HADS) assesses symptoms of anxiety and depression using two separate 7-item subscales (HADS-A and HADS-D). Each subscale has a minimum value of 0 and a maximum value of 21. A higher score indicates a worse outcome (greater severity of anxiety or depressive symptoms).
Time frame: Baseline and immediately after the 16-week intervention
Functional independence
The Lawton Instrumental Activities of Daily Living Scale (IADL) assesses an individual's ability to perform complex daily tasks necessary for independent community living. The instrument evaluates eight distinct functional domains. The scale has a minimum value of 0 and a maximum value of 8. A higher score indicates a better outcome, representing a higher level of functional independence and autonomy.
Time frame: Baseline and immediately after the 16-week intervention
Musculoskeletal complaints
Selected items from the Trøndelag Health Study (HUNT4) will be used for descriptive purposes to map chronic pain. The screening item registers the presence or absence of chronic pain. The subsequent 13 anatomical pain sites are formatted as checkboxes to register whether a complaint is present.
Time frame: Baseline and immediately after the 16-week intervention
Urinary incontinence
The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) assesses the frequency, severity, and impact of urinary incontinence on daily life. The instrument utilizes three scored items to calculate a total additive score, alongside one unscored self-diagnostic item. The scale has a minimum value of 0 and a maximum value of 21. A higher score indicates a worse outcome, representing greater symptom severity and a higher negative impact on quality of life.
Time frame: Baseline and immediately after the 16-week intervention
Endurance
The 6-Minute Walk Test evaluates functional exercise capacity and aerobic endurance. The test measures the total distance a participant can walk in a period of 6 minutes, with the outcome recorded in meters. A higher score indicates a better outcome (higher physical endurance and better functional mobility).
Time frame: Baseline and immediately after the 16-week intervention
Lower-body muscle strength and functional mobility
The 30-Second Chair Stand Test evaluates lower-body muscle strength and functional mobility. The test measures the total number of times a participant can stand up completely from a seated position in a period of 30 seconds without using their arms. A higher score indicates a better outcome.
Time frame: Baseline and immediately after the 16-week intervention
Hand grip strength
The Hand Grip Strength Test evaluates isometric muscular strength of the hand and forearm using a hand-held dynamometer. The test measures the maximum squeezing force exerted by the participant, with the outcome recorded in kilograms (kg). A higher score indicates a better outcome.
Time frame: Baseline and immediately after the 16-week intervention
Balance and postural stabilit
The One-Leg Standing Test evaluates static balance and postural stability. The test measures the total duration a participant can maintain balance standing on a single leg, with the outcome recorded in seconds. A higher score indicates a better outcome (superior static balance and lower fall risk).
Time frame: Baseline and immediately after the 16-week intervention
Body composition
Body Composition analysis using the InBody 770 evaluates body composition metrics (including skeletal muscle mass and body fat mass) via multi-frequency bioelectrical impedance analysis. Raw metrics are recorded in kilograms (kg) or percentages (%). For skeletal muscle mass, a higher score indicates a better outcome (greater muscle reserve), while for body fat mass, extreme scores in either direction indicate a worse outcome (clinical underweight or obesity).
Time frame: Baseline and immediately after the 16-week intervention
Metabolic biomarkers
Finger prick tests for glucose, cholesterol, and triglycerides evaluate metabolic biomarkers using a capillary blood sample. Metrics are recorded in millimoles per liter (mmol/L). For glucose, total cholesterol, LDL-cholesterol, and triglycerides, elevated levels indicate a worse outcome (metabolic risk). Conversely, for high-density lipoprotein (HDL) cholesterol, a higher score indicates a better outcome (cardiovascular protection).
Time frame: Baseline and immediately after the 16-week intervention
Device-measured physical activity
Device-measured physical activity using accelerometers evaluates movement patterns through continuous objective monitoring for seven days. Outcomes are recorded as raw acceleration counts, which are used to calculate time spent in moderate-to-vigorous physical activity in minutes. A higher score indicates a better outcome (higher physical fitness and physical activity level).
Time frame: Baseline and immediately after the 16-week intervention
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Norwegian School of Sport Sciences