AgingNCT03552042
Ageing as a Mindset: A Counterclockwise Experiment to Rejuvenate Older Adults
A study testing Counterclockwise program in people with Aging, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Ageing is generally perceived as a biologically-determined process. There is growing literature, however, that discusses the role of psychological factors in the ageing process. In particular, age-related stereotypes, which reflect the images that people have about the ageing process, seem to have a strong influence… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Counterclockwise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2018to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 75 years or older
- Cognitively preserved, assessed with a Mini Mental State Examination (Folstein, Robins, \& Helzer, 1983) score > 18
- Able to commit the time requested to join the retreat (one full week)
- Live in Milan (Italy), or close enough to travel to attend the assessments
Who cannot join
- Major disability that involves the use of a wheelchair or technological devices (e.g., communication device, invasive or non-invasive ventilation)
- Recent (<9 months) traumatic events (e.g., death of a close relative, life-threatening events)
- Traumatic events toward the end of the '80s or the beginning of the '90s
Trial locations and contacts
1 site in 1 country.
About this study
Ageing is generally perceived as a biologically-determined process. There is growing literature, however, that discusses the role of psychological factors in the ageing process. In particular, age-related stereotypes, which reflect the images that people have about the ageing process, seem to have a strong influence on health and life satisfaction, through self-fulfilling prophecy mechanisms. According to the stereotype embodiment theory, mindful changes in these images will promote a change in both the mind and the body, resulting, for example, in a rejuvenation and in a higher quality of life.
The project aims to investigate whether changes in mindsets (i.e., addressing one's age-related stereotypes) can change the ageing process. The psychological components of ageing, as well as how these could be reverted, will be investigated. In other words, the study aims to provide a first answer to the question: "can the mind be used to become younger?" To answer this question, the project will test the efficacy of an intervention labeled "counterclockwise", based on an original, yet un-replicated, pilot study by Ellen Langer, at Harvard. A group of older adults (aged 75+) will take part of a residential role-play game, in which they will relive their previous self, acting as if they were in the year 1989. The whole residential program, which will last one week, is designed to enhance this perception, including a retrofitted environment and social activities that will prime participants to relive that period.
Read more
The counterclockwise intervention will be tested against an active control group and a no-treatment group, with a randomized controlled trial. People in the active control group will spend a week in the same location of the counterclockwise intervention, mirroring the same activities, without any kind of time manipulation. Participants in the no-treatment group will only receive the assessment. Ninety participants will be randomly allocated to one of these three groups. Every participant will be assessed for medical, cognitive, psychological, and age appearance, four times: at the recruitment, after the intervention (i.e., after a week for the no-treatment group), and again after 6 and 12 months.
Expected results will be able to promote a mindset-shift not only in the participants but in the general population. The communication plan, which is integrated into the project plan, includes the presentation of the results to communities and associations of older adults, using the experiment as a proof of concept. It will demonstrate that challenging rigid, culturally driven, age-related stereotypes can result in health and well-being improvement. This is expected to lead to a significant improvement of empowerment and perceived control, with the potential to become viral in social communications.
- Conditions
- Aging
- Being tested
- Counterclockwise program, Active control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counterclockwise programBehavioural
A group of older adults (aged 75+) will take part of a residential role-play game, in which they will relive their previous self, acting as if they were in the year 1989. The whole residential program, which will last one week, is designed to enhance this perception, including a retrofitted environment and social activities that will prime participants to relive that period.
Active control groupBehavioural
Participants in the active control group will follow the same agenda of the Counterclockwise Program group, without the constant reference to 1989. The intervention will take place in the same location of the Counterclockwise Program, without any specific change. Activities will mirror the ones of Counterclockwise Program, but participants will not live as if they were younger. The agenda will be the same, but no mention to 1989 will be done. All discussion activities will refer to present days (e.g., instead of discussing the open of the Berlin Wall, they can discuss Brexit or Trump presidency).
| Study group | Role | What they receive |
|---|---|---|
| Counterclockwise Program | Experimental | Subjects will participate in an 6-day Counterclockwise Retreat in a retrofitted physical environment circa 1989, which helps the participant psychologically return to a time before diagnosis to re-experience their younger self. Groups will be composed of 10-12 participants plus 3 research assistants/facilitators. Participants will live during the week as if they were in 1989, talking about 1989 events as if they were in the present, and avoiding talking about post-1989 events. Everybody will be invited to participate in conversations and discussions about 1989 in the present tense (presente). Furniture, posters, music, television, newspapers, and technological instruments will all reflect what was available in 1989. Participants will be told not merely to reminisce about this earlier era, but to "inhabit" life in that era, making a psychological leap to be the person they were at the end of the 1980s. Receives: Behavioral: Counterclockwise program |
| Active control group | Active comparator | Participants in the active control group will follow the same agenda of the Counterclockwise Program group, without the constant reference to 1989. The intervention will take place in the same location of the Counterclockwise Program, without any specific change. Activities will mirror the ones of Counterclockwise Program, but participants will not live as if they were younger. The agenda will be the same, but no mention to 1989 will be done. All discussion activities will refer to present days (e.g., instead of discussing the open of the Berlin Wall, they can discuss Brexit or Trump presidency). Receives: Behavioral: Active control group |
| No-treatment control group | No intervention | Non-treated participants will be assessed with the same timeline followed by the other groups. Participants will receive three coupons, for each assessment after the baseline (at T2, T3, and T4) for a two-night break in a location of their choice (among a selection of commercial services). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Short Physical Performance Battery
Physical function will be assessed with the Short Physical Performance Battery (SPPB), a well-established measure of physical function in older adults (Guralnik et al., 1994). It assesses strength, gait, and balance by examining, respectively: (1) time to rise from a chair and return to the seated position five times; (2) time to walk eight feet; and (3) ability to stand with feet together in the side-by-side, semi-tandem, and tandem positions for 10 seconds. Possible scores ranged from 0 to 12, with a higher score indicating better physical performance. Older individuals who receive lower scores on this measure has increased risk of disability, nursing-home placement, and mortality (Levy, et al., 2014; Guralnik et al., 1994).
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Secondary outcomes (11)
Heart rate
Heart rate (HR) will be assessed with a Nonin 2500C-UNIV Universal Charger for 2500 Series with a mercury palm-style tat us.
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Blood pressure
Blood pressure (BP) will be measured with three 45-second readings on the participant's left harm.
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Oxygen saturation
Oxygen saturation is a term referring to the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood, and it will be measured with a Nonin 2500C-UNIV Universal Charger for 2500 Series.
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Respiratory rate
Respiratory Rate (RR) is the number of breaths per minute, which will be collected to determine whether the respirations are normal, abnormally fast, abnormally slow, or nonexistent.
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Memory
Memory will be assessed with the Babcock Story Recall Test (Freides and Avery, 1991). In this verbal memory test, a brief news is presented, and immediate recall is obtained. The story is then presented a second time, and after administration of intervening tasks, delayed recall is obtained. Scores for several normative samples have been reported and it is considered a valid method for assessing verbal memory. Good inter-rater reliability has previously been reported (Freides \& Avery, 1991).
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Attentive function
Attentive function will be evaluated with the Dual Task Performance, a pencil-and-paper test of divided attention, which consists of two components, a digit span task and a visuo-spatial tracking task. Each task is performed both separately and concurrently (Della Sala, et al., 2010).
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Psychological well-being
The Psychological General Well-being Index (PGWBI) is a questionnaire that assesses well-being. It is composed by 22 items representing six dimensions: anxiety, depressed mood, positive well-being, self- control, general health, and vitality. It is a widely used tool to asses quality of life, and it has excellent psychometric validity (Ruini, C., et al., 2003). The total score ranges from 0 to 110, with higher values indicating higher well-being. Subscale score ranges are: anxiety, 0-25; depressed mood, 0-15; positive well-being, 0-20; self-control, 0-15; general health, 0-15; and vitality, 0-20. Higher scores are associated with better outcomes (i.e., always "positive"). The total score is provided by the sum of the subscales.
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Anxiety
Anxiety will be evaluated with the Geriatric Anxiety Inventory (GAI; Pachana et al., 2007), a 20-item measure of anxiety symptoms, specifically developed for older adults. It has been shown to have adequate internal consistency, test-retest reliability and concurrent validity (Pachana, et al., 2007). The scale ranges from 0 to 60, with higher scores indicating higher levels of anxiety.
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Depression
Depression will be assessed with the Geriatric Depression Scale (GDS; Yesavage et al., 1983), a 30-item self- report measure of depressive symptoms, developed for older adults. The validity and reliability of this tool have been supported through both clinical practice and research (Yesavage et al., 1983). Questions are answered "yes" or "no." One point is assigned to each answer and the cumulative score is rated on a scoring grid, which sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed". The total score ranges from 0 to 30.
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Ageing stereotypes
Ageing stereotypes will be evaluated with the open-ended Image-of-Aging question: "What are the first five words or phrases that come to mind when you think of an older person?" (Levy \& Langer, 1994). Three independent raters will score responses on a Likert scale ranging from 1 (very negative) to 5 (very positive), which will be combined as an average, providing one single score. This measure produces responses rated as stereotypical of old age (Levy, Slade, \& Gill, 2006), predicts physical recovery (Levy, Slade, Murphy \& Gill, 2012), and shows expected variability and cross-cultural patterns (Levy \& Langer, 1994).
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Appearance
Participants will be photographed at each assessment to evaluate age appearance. The photos will have a neutral (i.e., white) background and will have the same instructions: "please, smile to the camera". University students will blindly guess the age of every person in each picture. Pictures will be showed online with a random allocation through the Qualtrics suite to at least 200 undergraduate students. The final score for each picture will be the average age guessed by students.
Measured: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS, Harvard University
- Responsible party
- Principal investigator, Francesco Pagnini, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552042
- Sponsor's protocol ID
- Ageing01
- Status last verified
- Jul 2021
- First submitted
- 10 May 2018
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pagnini F, Cavalera C, Volpato E, Comazzi B, Vailati Riboni F, Valota C, Bercovitz K, Molinari E, Banfi P, Phillips D, Langer E. Ageing as a mindset: a study protocol to rejuvenate older adults with a counterclockwise psychological intervention. BMJ Open. 2019 Jul 9;9(7):e030411. doi: 10.1136/bmjopen-2019-030411.
PubMed 31289097
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ageing as a Mindset: A Counterclockwise Experiment to Rejuvenate Older Adults
- ClinicalTrials.gov ID
- NCT03552042
- Acronym / sponsor ID
- Ageing01
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Fondazione Don Carlo Gnocchi ETS, Harvard University
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Jun 2018 (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.
Ageing is generally perceived as a biologically-determined process. There is growing literature, however, that discusses the role of psychological factors in the ageing process. In particular, age-related stereotypes, which reflect the images that people have about the ageing process, seem to have a strong influence on health and life satisfaction, through self-fulfilling prophecy mechanisms. According to the stereotype embodiment theory, mindful changes in these images will promote a change in both the mind and the body, resulting, for example, in a rejuvenation and in a higher quality of life.
The project aims to investigate whether changes in mindsets (i.e., addressing one's age-related stereotypes) can change the ageing process. The psychological components of ageing, as well as how these could be reverted, will be investigated. In other words, the study aims to provide a first answer to the question: "can the mind be used to become younger?" To answer this question, the project will test the efficacy of an intervention labeled "counterclockwise", based on an original, yet un-replicated, pilot study by Ellen Langer, at Harvard. A group of older adults (aged 75+) will take part of a residential role-play game, in which they will relive their previous self, acting as if they were in the year 1989. The whole residential program, which will last one week, is designed to enhance this perception, including a retrofitted environment and social activities that will prime participants to relive that period.
The counterclockwise intervention will be tested against an active control group and a no-treatment group, with a randomized controlled trial. People in the active control group will spend a week in the same location of the counterclockwise intervention, mirroring the same activities, without any kind of time manipulation. Participants in the no-treatment group will only receive the assessment. Ninety participants will be randomly allocated to one of these three groups. Every participant will be assessed for medical, cognitive, psychological, and age appearance, four times: at the recruitment, after the intervention (i.e., after a week for the no-treatment group), and again after 6 and 12 months.
Expected results will be able to promote a mindset-shift not only in the participants but in the general population. The communication plan, which is integrated into the project plan, includes the presentation of the results to communities and associations of older adults, using the experiment as a proof of concept. It will demonstrate that challenging rigid, culturally driven, age-related stereotypes can result in health and well-being improvement. This is expected to lead to a significant improvement of empowerment and perceived control, with the potential to become viral in social communications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Counterclockwise Program | Experimental | Behavioral: Counterclockwise programSubjects will participate in an 6-day Counterclockwise Retreat in a retrofitted physical environment circa 1989, which helps the participant psychologically return to a time before diagnosis to re-experience their younger self. Groups will be composed of 10-12 participants plus 3 research assistants/facilitators. Participants will live during the week as if they were in 1989, talking about 1989 events as if they were in the present, and avoiding talking about post-1989 events. Everybody will be invited to participate in conversations and discussions about 1989 in the present tense (presente). Furniture, posters, music, television, newspapers, and technological instruments will all reflect what was available in 1989. Participants will be told not merely to reminisce about this earlier era, but to "inhabit" life in that era, making a psychological leap to be the person they were at the end of the 1980s. |
| Active control group | Active comparator | Behavioral: Active control groupParticipants in the active control group will follow the same agenda of the Counterclockwise Program group, without the constant reference to 1989. The intervention will take place in the same location of the Counterclockwise Program, without any specific change. Activities will mirror the ones of Counterclockwise Program, but participants will not live as if they were younger. The agenda will be the same, but no mention to 1989 will be done. All discussion activities will refer to present days (e.g., instead of discussing the open of the Berlin Wall, they can discuss Brexit or Trump presidency). |
| No-treatment control group | No intervention | –Non-treated participants will be assessed with the same timeline followed by the other groups. Participants will receive three coupons, for each assessment after the baseline (at T2, T3, and T4) for a two-night break in a location of their choice (among a selection of commercial services). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 75 years or older
- Cognitively preserved, assessed with a Mini Mental State Examination (Folstein, Robins, \& Helzer, 1983) score > 18
- Able to commit the time requested to join the retreat (one full week)
- Live in Milan (Italy), or close enough to travel to attend the assessments
Key exclusion criteria (3 listed)
- Major disability that involves the use of a wheelchair or technological devices (e.g., communication device, invasive or non-invasive ventilation)
- Recent (<9 months) traumatic events (e.g., death of a close relative, life-threatening events)
- Traumatic events toward the end of the '80s or the beginning of the '90s
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 |
|---|---|---|
| Counterclockwise programA group of older adults (aged 75+) will take part of a residential role-play game, in which they will relive their previous self, acting as if they were in the year 1989. The whole residential program, which will last one week, is designed to enhance this perception, including a retrofitted environment and social activities that will prime participants to relive that period. | Behavioural | Counterclockwise Program |
| Active control groupParticipants in the active control group will follow the same agenda of the Counterclockwise Program group, without the constant reference to 1989. The intervention will take place in the same location of the Counterclockwise Program, without any specific change. Activities will mirror the ones of Counterclockwise Program, but participants will not live as if they were younger. The agenda will be the same, but no mention to 1989 will be done. All discussion activities will refer to present days (e.g., instead of discussing the open of the Berlin Wall, they can discuss Brexit or Trump presidency). | Behavioural | Active control group |
Primary outcome
Change in the Short Physical Performance Battery
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Physical function will be assessed with the Short Physical Performance Battery (SPPB), a well-established measure of physical function in older adults (Guralnik et al., 1994). It assesses strength, gait, and balance by examining, respectively: (1) time to rise from a chair and return to the seated position five times; (2) time to walk eight feet; and (3) ability to stand with feet together in the side-by-side, semi-tandem, and tandem positions for 10 seconds. Possible scores ranged from 0 to 12, with a higher score indicating better physical performance. Older individuals who receive lower scores on this measure has increased risk of disability, nursing-home placement, and mortality (Levy, et al., 2014; Guralnik et al., 1994).
11 secondary outcomes
Heart rate
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Blood pressure
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Oxygen saturation
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Respiratory rate
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Memory
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Attentive function
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Psychological well-being
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Anxiety
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Depression
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Ageing stereotypes
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Appearance
Time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 31289097Pagnini F, Cavalera C, Volpato E, Comazzi B, Vailati Riboni F, Valota C, Bercovitz K, Molinari E, Banfi P, Phillips D, Langer E. Ageing as a mindset: a study protocol to rejuvenate older adults with a counterclockwise psychological intervention. BMJ Open. 2019 Jul 9;9(7):e030411. doi: 10.1136/bmjopen-2019-030411.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counterclockwise program in people with Aging, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 27 Jul 2021. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Short Physical Performance Battery (time frame: Assessed at recruitment; after completing the intervention, i.e., one week after recruitment for the non-treated control group; at a 6-month follow-up; at a 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03552042, which also lists 1 linked publication.
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 Jul 2021.