Intrinsic CapacityFORMULA 100NCT07829120
Multidomain Intervention Based on ICOPE
A study testing Multidomain intervention in people with Intrinsic Capacity, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
FORMULA 100 is a prospective, single-arm feasibility study conducted at two Active Ageing Centers in Monza, Italy, involving community-dwelling adults aged 65 years and older. The study will test whether an Integrated Care for Older People (ICOPE)-based care pathway can be implemented in this setting. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intrinsic Capacity
- What is being tested?
- Multidomain intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to 31 Mar 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Attendance at one of the Active Ageing Centers participating in the project
- Evidence of impairment in at least one key domain of intrinsic capacity, as identified through the first-level ICOPE screening
- Ability to walk independently (with or without a walking aid)
- Ability to communicate and cooperate with the research team
Who cannot join
- Clinical conditions precluding completion of the first-level ICOPE screening or safe participation in the study, including severe dementia, bilateral blindness, end-stage diseases (e.g., Child-Pugh class C liver cirrhosis, stage 5 chronic kidney disease, chronic obstructive pulmonary disease Global Initiative for Chronic Obstructive Lung Disease group D, end-stage heart failure, or advanced cancer)
- Concurrent participation in another clinical study
- Refusal or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Active Ageing Centers (organized by Sociosfera)
Monza, Monza E Brianza, 20900
Sociosfera president, +39 3408747301, a.lex@sociosfera.it
Manuela Grimoldi, m.grimoldi@sociosfera.it
About this study
Official title: FORMULA 100: an ICOPE-based Multidomain Intervention to Promote Active and Healthy Ageing.
FORMULA 100 is a prospective, single-arm feasibility study conducted at two Active Ageing Centers in Monza, Italy, involving community-dwelling adults aged 65 years and older. The study will test whether an Integrated Care for Older People (ICOPE)-based care pathway can be implemented in this setting.
Participants will first be screened for possible decline in intrinsic capacity (IC). Those enrolled will then undergo a multidimensional assessment and receive a personalized 3-month intervention tailored to their needs. The intervention may address physical, cognitive, nutritional, psychological, sensory, and social needs and may also include a review of medications.
Participants will be reassessed after 3 months and again after 6 months. The main study outcome is the proportion of participants who complete the 6-month follow-up. About 300 people are expected to be screened, with a target enrollment of 250 participants.
- Conditions
- Intrinsic Capacity
- Being tested
- Multidomain intervention
- Keywords
- intrinsic capacity, multidomain intervention, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain interventionOther
Following the in-depth assessment, each participant receives a personalized 3-month multidomain intervention plan tailored to identified IC impairments, clinical status, preferences, and social context. A multidisciplinary team provides multicomponent physical exercise based on Vivifrail for all participants, alongside targeted interventions for cognitive impairment, overt malnutrition or risk of malnutrition, depressive symptoms, sensory deficits, and social isolation. Regular medications are also reviewed using STOPP/START criteria, with recommendations communicated to the participant and primary care physician.
| Study group | Role | What they receive |
|---|---|---|
| Multidomain intervention | Experimental | Not described Receives: Other: Multidomain intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICOPE-based program feasibility, operationalized as the study completion rate at 6 months.
This retention rate is defined as the proportion of enrolled participants who complete the entire study pathway, with a prespecified feasibility target of ≥80%.
Measured: 6 months
Secondary outcomes (4)
Prevalence of IC-domain impairments
Baseline prevalence of impairment in each IC domain, as identified through the first-level screening and further confirmed through the in-depth assessment
Measured: Baseline
Prevalence of frailty
Baseline prevalence of frailty
Measured: Baseline
Adherence to multidomain interventions
Mean proportion of prescribed intervention sessions completed
Measured: 3 months
Participant satisfaction
Likert-5 point questionnaire
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Dec 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intrinsic CapacityStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm feasibility study of a multidomain intervention conducted at two Active Ageing Centers (AACs) in Monza, Lombardy (Italy).
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- Cariplo Foundation
- Responsible party
- Sponsor
- Investigators
- Giuseppe Bellelli, Medical doctor, full professor, Principal investigator, University of Milano-Bicocca, IRCCS Foundation San Gerardo dei Tintori
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829120
- Sponsor's protocol ID
- N. 0447865 (20/10/2025)
- Other IDs
- Ref. 2024-2810 (28/01/2025)
- Acronym
- FORMULA 100
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets that will be produced during the study will be available on reasonable request to the Principal Investigator.
Publications
Ferrara MC, Perez LM, Sole AR, Villa-Garcia L, Ars J, Soto-Bagaria L, Bellelli G, Cesari M, Enfedaque MB, Inzitari M. Sustained improvement of intrinsic capacity in community-dwelling older adults: The +AGIL Barcelona multidomain program. J Intern Med. 2023 Dec;294(6):730-742. doi: 10.1111/joim.13710. Epub 2023 Aug 21.
PubMed 37574781Merchant RA, Liu Y, Tan LF, Yeo L, Sandrasageran S, Tay YK, Seet A, Chua L, Tan WM, Vellas B. Community-Based ICOPE Screening Identifies Intrinsic Capacity Impairment and Supports Integrated Health and Social Care. J Am Med Dir Assoc. 2026 Aug 4;27(10):106414. doi: 10.1016/j.jamda.2026.106414. Online ahead of print.
PubMed 42551140Yan Wang N, Liu X, Kong X, Sumi Y, Chhetri JK, Hu L, Zhu M, Kang L, Liang Z, Ellis JW, Shi L. Implementation and impact of the World Health Organization integrated care for older people (ICOPE) program in China: a randomised controlled trial. Age Ageing. 2024 Jan 2;53(1):afad249. doi: 10.1093/ageing/afad249.
PubMed 38251736Tavassoli N, Piau A, Berbon C, De Kerimel J, Lafont C, De Souto Barreto P, Guyonnet S, Takeda C, Carrie I, Angioni D, Paris F, Mathieu C, Ousset PJ, Balardy L, Voisin T, Sourdet S, Delrieu J, Bezombes V, Pons-Pretre V, Andrieu S, Nourhashemi F, Rolland Y, Soto ME, Beard J, Sumi Y, Araujo Carvalho I, Vellas B. Framework Implementation of the INSPIRE ICOPE-CARE Program in Collaboration with the World Health Organization (WHO) in the Occitania Region. J Frailty Aging. 2021;10(2):103-109. doi: 10.14283/jfa.2020.26.
PubMed 33575698Malkowski OS, Davis-Plourde K, Western MJ, Gill TM. Association between intrinsic capacity and disability before death among older adults: a decedent cohort study. Lancet Healthy Longev. 2026 May;7(5):100854. doi: 10.1016/j.lanhl.2026.100854. Epub 2026 Jun 9.
PubMed 42263724Cesari M, Canevelli M, Amuthavalli Thiyagarajan J, Arai H, Assantachai P, Chan P, Chhetri JK, Ferriolli E, Geffen L, Gregson CL, Guaraldi G, Gutierrez Robledo LM, Hammami S, Jang H, Kalula S, Mathur A, Merchant RA, Oliveira D, Perracini MR, Petrovic M, Polidori-Nelles MC, Rodriguez Manas L, Rowe JW, Sabzwari S, Sadana R, Sumi Y, Tomarevska O, Vellas B, Visvanathan R, Woo J, Martin FC. Frailty and intrinsic capacity: integrating complementary concepts to promote healthy ageing and transformation of care. Age Ageing. 2026 May 4;55(5):afag138. doi: 10.1093/ageing/afag138.
PubMed 42166522Sanchez-Sanchez JL, Lu WH, Gallardo-Gomez D, Del Pozo Cruz B, de Souto Barreto P, Lucia A, Valenzuela PL. Association of intrinsic capacity with functional decline and mortality in older adults: a systematic review and meta-analysis of longitudinal studies. Lancet Healthy Longev. 2024 Jul;5(7):e480-e492. doi: 10.1016/S2666-7568(24)00092-8.
PubMed 38945130Sum G, Lau LK, Jabbar KA, Lun P, George PP, Munro YL, Ding YY. The World Health Organization (WHO) Integrated Care for Older People (ICOPE) Framework: A Narrative Review on Its Adoption Worldwide and Lessons Learnt. Int J Environ Res Public Health. 2022 Dec 22;20(1):154. doi: 10.3390/ijerph20010154.
PubMed 36612480
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FORMULA 100: an ICOPE-based Multidomain Intervention to Promote Active and Healthy Ageing.
- ClinicalTrials.gov ID
- NCT07829120
- Acronym / sponsor ID
- FORMULA 100 / N. 0447865 (20/10/2025)
- Conditions
- Intrinsic Capacity
- Keywords
- intrinsic capacity, multidomain intervention, older adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- Cariplo Foundation
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 Sep 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.
FORMULA 100 is a prospective, single-arm feasibility study conducted at two Active Ageing Centers in Monza, Italy, involving community-dwelling adults aged 65 years and older. The study will test whether an Integrated Care for Older People (ICOPE)-based care pathway can be implemented in this setting.
Participants will first be screened for possible decline in intrinsic capacity (IC). Those enrolled will then undergo a multidimensional assessment and receive a personalized 3-month intervention tailored to their needs. The intervention may address physical, cognitive, nutritional, psychological, sensory, and social needs and may also include a review of medications.
Participants will be reassessed after 3 months and again after 6 months. The main study outcome is the proportion of participants who complete the 6-month follow-up. About 300 people are expected to be screened, with a target enrollment of 250 participants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm feasibility study of a multidomain intervention conducted at two Active Ageing Centers (AACs) in Monza, Lombardy (Italy).
| Arm | Type | Receives |
|---|---|---|
| Multidomain intervention | Experimental | Other: Multidomain intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years
- Attendance at one of the Active Ageing Centers participating in the project
- Evidence of impairment in at least one key domain of intrinsic capacity, as identified through the first-level ICOPE screening
- Ability to walk independently (with or without a walking aid)
- Ability to communicate and cooperate with the research team
Key exclusion criteria (3 listed)
- Clinical conditions precluding completion of the first-level ICOPE screening or safe participation in the study, including severe dementia, bilateral blindness, end-stage diseases (e.g., Child-Pugh class C liver cirrhosis, stage 5 chronic kidney disease, chronic obstructive pulmonary disease Global Initiative for Chronic Obstructive Lung Disease group D, end-stage heart failure, or advanced cancer)
- Concurrent participation in another clinical study
- Refusal or inability to provide written informed consent
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 |
|---|---|---|
| Multidomain interventionFollowing the in-depth assessment, each participant receives a personalized 3-month multidomain intervention plan tailored to identified IC impairments, clinical status, preferences, and social context. A multidisciplinary team provides multicomponent physical exercise based on Vivifrail for all participants, alongside targeted interventions for cognitive impairment, overt malnutrition or risk of malnutrition, depressive symptoms, sensory deficits, and social isolation. Regular medications are also reviewed using STOPP/START criteria, with recommendations communicated to the participant and primary care physician. | Other | Multidomain intervention |
Primary outcome
ICOPE-based program feasibility, operationalized as the study completion rate at 6 months.
Time frame: 6 months
This retention rate is defined as the proportion of enrolled participants who complete the entire study pathway, with a prespecified feasibility target of ≥80%.
4 secondary outcomes
Prevalence of IC-domain impairments
Time frame: Baseline
Prevalence of frailty
Time frame: Baseline
Adherence to multidomain interventions
Time frame: 3 months
Participant satisfaction
Time frame: 3 months and 6 months
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 18 Sep 2026.
- Background: PubMed 37574781Ferrara MC, Perez LM, Sole AR, Villa-Garcia L, Ars J, Soto-Bagaria L, Bellelli G, Cesari M, Enfedaque MB, Inzitari M. Sustained improvement of intrinsic capacity in community-dwelling older adults: The +AGIL Barcelona multidomain program. J Intern Med. 2023 Dec;294(6):730-742. doi: 10.1111/joim.13710. Epub 2023 Aug 21.
- Background: PubMed 42551140Merchant RA, Liu Y, Tan LF, Yeo L, Sandrasageran S, Tay YK, Seet A, Chua L, Tan WM, Vellas B. Community-Based ICOPE Screening Identifies Intrinsic Capacity Impairment and Supports Integrated Health and Social Care. J Am Med Dir Assoc. 2026 Aug 4;27(10):106414. doi: 10.1016/j.jamda.2026.106414. Online ahead of print.
- Background: PubMed 38251736Yan Wang N, Liu X, Kong X, Sumi Y, Chhetri JK, Hu L, Zhu M, Kang L, Liang Z, Ellis JW, Shi L. Implementation and impact of the World Health Organization integrated care for older people (ICOPE) program in China: a randomised controlled trial. Age Ageing. 2024 Jan 2;53(1):afad249. doi: 10.1093/ageing/afad249.
- Background: PubMed 33575698Tavassoli N, Piau A, Berbon C, De Kerimel J, Lafont C, De Souto Barreto P, Guyonnet S, Takeda C, Carrie I, Angioni D, Paris F, Mathieu C, Ousset PJ, Balardy L, Voisin T, Sourdet S, Delrieu J, Bezombes V, Pons-Pretre V, Andrieu S, Nourhashemi F, Rolland Y, Soto ME, Beard J, Sumi Y, Araujo Carvalho I, Vellas B. Framework Implementation of the INSPIRE ICOPE-CARE Program in Collaboration with the World Health Organization (WHO) in the Occitania Region. J Frailty Aging. 2021;10(2):103-109. doi: 10.14283/jfa.2020.26.
- Background: PubMed 42263724Malkowski OS, Davis-Plourde K, Western MJ, Gill TM. Association between intrinsic capacity and disability before death among older adults: a decedent cohort study. Lancet Healthy Longev. 2026 May;7(5):100854. doi: 10.1016/j.lanhl.2026.100854. Epub 2026 Jun 9.
- Background: PubMed 42166522Cesari M, Canevelli M, Amuthavalli Thiyagarajan J, Arai H, Assantachai P, Chan P, Chhetri JK, Ferriolli E, Geffen L, Gregson CL, Guaraldi G, Gutierrez Robledo LM, Hammami S, Jang H, Kalula S, Mathur A, Merchant RA, Oliveira D, Perracini MR, Petrovic M, Polidori-Nelles MC, Rodriguez Manas L, Rowe JW, Sabzwari S, Sadana R, Sumi Y, Tomarevska O, Vellas B, Visvanathan R, Woo J, Martin FC. Frailty and intrinsic capacity: integrating complementary concepts to promote healthy ageing and transformation of care. Age Ageing. 2026 May 4;55(5):afag138. doi: 10.1093/ageing/afag138.
- Background: PubMed 38945130Sanchez-Sanchez JL, Lu WH, Gallardo-Gomez D, Del Pozo Cruz B, de Souto Barreto P, Lucia A, Valenzuela PL. Association of intrinsic capacity with functional decline and mortality in older adults: a systematic review and meta-analysis of longitudinal studies. Lancet Healthy Longev. 2024 Jul;5(7):e480-e492. doi: 10.1016/S2666-7568(24)00092-8.
- Background: PubMed 36612480Sum G, Lau LK, Jabbar KA, Lun P, George PP, Munro YL, Ding YY. The World Health Organization (WHO) Integrated Care for Older People (ICOPE) Framework: A Narrative Review on Its Adoption Worldwide and Lessons Learnt. Int J Environ Res Public Health. 2022 Dec 22;20(1):154. doi: 10.3390/ijerph20010154.
- Individual participant dataSharing planned: Undecided. The datasets that will be produced during the study will be available on reasonable request to the Principal Investigator.
Related trials for Intrinsic Capacity
Not yet recruiting
Exercise in Alzheimer's Disease: Functional Biomarkers
Alzheimer's Dementia (AD), Alzheimer Disease (AD)
RecruitingObservational study
Functional Capacity in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
The Effects of an Empower_ICE-Fit Program in PLwD Living at Home
Dementia
Recruiting
Effects of Respiratory Muscle Strengthening and Diaphragmatic Breathing on Shoulder Pain and Disability
Shoulder Pain, Sleep Quality
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
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.
Giuseppe Bellelli, Medical doctor, full professor principal investigator
University of Milano-Bicocca, IRCCS Foundation San Gerardo dei Tintori
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain intervention in people with Intrinsic Capacity, run by University of Milano Bicocca 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 5 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: looking for participants now, as of the sponsor's last update on 18 Sep 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 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?
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 Maria Cristina Ferrara, Medical doctor and PhD (+39 0392339719, mariacristina.ferrara@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICOPE-based program feasibility, operationalized as the study completion rate at 6 months. (time frame: 6 months). 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 NCT07829120, which also lists 8 linked publications.
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 18 Sep 2026.