LonelinessALIVENCT07789080
The ALIVE-Project: Activity, Life Satisfaction, Inclusion, Vitality, Elderly Women
A study testing Supervised Group Exercise in Fitness Clubs and Individual exercise in people with Loneliness and Social Isolation in Older Adults, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Social Isolation in Older Adults, Physical Inactivity
- What is being tested?
- Supervised Group Exercise in Fitness Clubs and Individual exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 100 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Norwegian School of Sport Sciences
Oslo, Oslo, 0863
Emilie Dalhaug, +47 91708426, emiliefm@nih.no
About this study
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.
Read more
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.
- Being tested
- Supervised Group Exercise in Fitness Clubs, Individual exercise
- Keywords
- Loneliness, Healthy Ageing, Socal isolation, Older adults
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Group Exercise in Fitness ClubsBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and immediately after the 16-week intervention
Secondary outcomes (12)
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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and immediately after the 16-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- SATS - Sport Aerobic Trenings Senter, Oslo University Hospital
- Responsible party
- Principal investigator, Lene A. H. Haakstad, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789080
- Sponsor's protocol ID
- 52300 850026-100
- Acronym
- ALIVE
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ALIVE-Project: Activity, Life Satisfaction, Inclusion, Vitality, Elderly Women
- ClinicalTrials.gov ID
- NCT07789080
- Acronym / sponsor ID
- ALIVE / 52300 850026-100
- Keywords
- Loneliness, Healthy Ageing, Socal isolation, Older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- SATS - Sport Aerobic Trenings Senter, Oslo University Hospital
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group exercise | Experimental | Behavioral: Supervised Group Exercise in Fitness ClubsParticipants 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. |
| PA Individually | Experimental | Behavioral: Individual exerciseParticipants 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. |
| 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. |
Who may qualify
- Ages
- 75 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Group Exercise in Fitness ClubsParticipants 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. | Behavioural | Group exercise |
| Individual exerciseParticipants 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. | Behavioural | PA Individually |
Primary outcome
Loneliness and socal isolation
Time frame: Baseline and immediately after the 16-week intervention
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).
12 secondary outcomes
Health-related quality of life
Time frame: Baseline and immediately after the 16-week intervention
Depression and anxiety
Time frame: Baseline and immediately after the 16-week intervention
Functional independence
Time frame: Baseline and immediately after the 16-week intervention
Musculoskeletal complaints
Time frame: Baseline and immediately after the 16-week intervention
Urinary incontinence
Time frame: Baseline and immediately after the 16-week intervention
Endurance
Time frame: Baseline and immediately after the 16-week intervention
Lower-body muscle strength and functional mobility
Time frame: Baseline and immediately after the 16-week intervention
Hand grip strength
Time frame: Baseline and immediately after the 16-week intervention
Balance and postural stabilit
Time frame: Baseline and immediately after the 16-week intervention
Body composition
Time frame: Baseline and immediately after the 16-week intervention
Metabolic biomarkers
Time frame: Baseline and immediately after the 16-week intervention
Device-measured physical activity
Time frame: Baseline and immediately after the 16-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Group Exercise in Fitness Clubs and Individual exercise in people with Loneliness and Social Isolation in Older Adults, run by Norwegian School of Sport Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie Dalhaug (+ 47 91708426, emiliefm@nih.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness and socal isolation (time frame: Baseline and immediately after the 16-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.