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| ID | Type | Description | Link |
|---|---|---|---|
| IMI-JU-09-2013-02 | Other Grant/Funding Number | Innovative Medicine Initiative |
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The SPRINTT study will evaluate the efficacy of a multicomponent intervention programme (physical activity, nutritional counselling/dietary intervention, and information and communications technology intervention) compared with a healthy aging lifestyle education programme on mobility disability, in non-disabled older people with physical frailty and sarcopenia.
As the life expectancy in European countries continues to increase, the maintenance of physical independence in older persons has become a major public health priority. The ability to ambulate without assistance is crucial for independent living and it is often the first ability to be lost in the process leading to disability. Older people who have impaired walking function need more assistance and are more likely to be placed in nursing homes, have a higher risk of morbidity, mortality and hospitalisation, and experience a reduced quality of life. The ultimate goals of the Sarcopenia and Physical fRailty IN older people: multicomponenT Treatment strategies (SPRINTT) project are to offer efficient treatment options, based on a multicomponent intervention including physical activity, nutrition and information and communications technology, to physically frail, sarcopenic older persons and to improve their quality of life. The result will directly contribute to the long-term sustainability and efficiency of health- and social-care systems. The conceptualisation of physical frailty and sarcopenia (PF&S) as proposed in SPRINTT will promote significant advancements over the traditional approaches by enabling the precise operationalisation of the condition, a clear identification of the affected population and the rapid translation of findings to the clinical arena.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent intervention (MCI) | Experimental | The multicomponent intervention will include a physical activity programme, a nutritional intervention and an information and communications intervention. |
|
| Healthy Aging Lifestyle Education (HALE) | Active Comparator | The health aging lifestyle education programme will be based on workshops. Participants will receive information on a variety of topics of relevance to older persons (e.g., recommended preventive services and screenings at different ages). The programme will also include a short instructor-led programme (5-10 minutes) of upper extremity stretching exercises or some relaxation techniques that will be performed at the end of each workshop. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent intervention (MCI) | Other | The multicomponent intervention will include physical activity (PA), nutrition and information and communications technology (ICT). The PA will be of moderate intensity and will include aerobic, strength, flexibility, and balance training. Walking will be the primary mode of PA . The nutritional intervention will combine individual nutritional assessment and personalised dietary recommendations to achieve:
The ICT component will involve the use of an ad hoc technological device to record actimetry data to support the elaboration of a personalised training programme. |
| Measure | Description | Time Frame |
|---|---|---|
| Incident of major mobility disability | Incident inability to complete the 400-metre walk test (incidence of major mobility disability) | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lower extremity physical performance | Changes in short physical performance battery (SPPB) summary score | 36 months |
| Changes in upper extremity muscle strength | Changes in handgrip strength test performance (kg) |
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Inclusion criteria:
Short Physical Performance Battery (SPPB) score between 3 (included) and 9 (included);
Able to complete the 400-m walk test within 15 min without sitting down, help from another person, use of a walker, or stopping for more than 1 minute at a time;
Presence of low muscle mass based on Dual Energy X-Ray Absorptiometry (DXA) scan, according to the Foundation for the National Institutes of Health Sarcopenia Project (FNIH) criteria:
Willingness to be randomised to either intervention group and to follow the study protocol.
Exclusion criteria:
General
Clinical conditions:
Temporary exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuele Marzetti, MD, PhD | Contact | +39 06 3015 | 5559 | emarzetti@live.com |
| Riccardo Calvani, PhD | Contact | +39 06 3015 | 5559 | riccardo.calvani@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Landi, MD, PhD | Catholic University of the Sacred Heart | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of the Sacred Heart | Recruiting | Rome | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40669418 | Derived | Coelho-Junior HJ, Alvarez-Bustos A, Rodriguez-Manas L, Landi F, Marzetti E. Comparison of muscle strength and power in the short physical performance battery for predicting negative outcomes in older adults with mobility limitations. J Nutr Health Aging. 2025 Sep;29(9):100631. doi: 10.1016/j.jnha.2025.100631. Epub 2025 Jul 15. | |
| 40665144 |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Healthy Aging Lifestyle Education (HALE) | Other | The healthy aging lifestyle education programme will be based on a workshop series. Participants will receive information on a variety of topics of relevance to older adults (e.g., recommended preventive services and screenings at different ages). The programme will also include a short instructor-led programme (5-10 minutes) of upper extremity stretching exercises or some relaxation techniques that will be performed at the end of each workshop. |
|
| 36 months |
| Changes in functional status (activities of daily living) | Changes in Activities of Daily Living (ADL) score computed through a modified version of the Pepper Assessment Tool for Disability (PAT-D) | 36 months |
| Changes in functional status (instrumental activities of daily living) | Changes in Instrumental Activities of Daily Living (IADL) score computed through a modified version of the Pepper Assessment Tool for Disability (PAT-D) | 36 months |
| Changes in crude appendicular lean mass | Changes in crude in appendicular lean mass (kg) by Dual Energy X-Ray Absorptiometry | 36 months |
| Changes in body mass index-adjusted appendicular lean mass | Changes in body mass index-adjusted appendicular lean mass (adimensional) by Dual Energy X-Ray Absorptiometry | 36 months |
| Persistent mobility disability | Inability to complete the 400-metre walk test at two consecutive semiannual visits | 36 months |
| Changes in body weight | Changes in body weight (kg) | 36 months |
| Changes in body mass index | Changes in body mass index (kg/m^2) | 36 months |
| Changes in mid-arm circumference | Changes in mid-arm circumference (cm) | 36 months |
| Changes in waist circumference | Changes in waist circumference (cm) | 36 months |
| Changes in hip circumference | Changes in hip circumference (cm) | 36 months |
| Changes in calf circumference | Changes in calf circumference (cm) | 36 months |
| Changes in nutritional status | Changes in Mini Nutritional Assessment-Short Form (MNA-SF) score | 36 months |
| Changes in cognitive function | Changes in Mini Mental State Examination (MMSE) score | 36 months |
| Changes in mood | Changes in 11-item Center for Epidemiological Studies - Depression (CES-D) scale score | 36 months |
| Incidence of self-reported falls | Number of falls assessed by questionnaires | 36 months |
| Incidence of injurious falls | Number of injurious falls assessed by questionnaires | 36 months |
| Changes in quality of life | Changes in EuroQoL-5D (EQ5D) score | 36 months |
| Changes in the use of healthcare services | Health economics questionnaire | 36 months |
| All-cause mortality | Mortality rate | 36 months |
| Cost effectiveness | Cost effectiveness analysis | 36 months |
| Levati E, Zazzara MB, Iurlaro A, Marzetti E, Calvani R, Pahor M, Picca A, Tosato M, Landi F, Bernabei R, Onder G. Lifestyle interventions and medication burden in older adults: insights from the Lifestyle Intervention and Independence for Elders (LIFE) and the Sarcopenia and Physical fRailty iN older people: multi-componenT Treatment strategies (SPRINTT) trials. Eur Geriatr Med. 2025 Oct;16(5):1591-1598. doi: 10.1007/s41999-025-01266-0. Epub 2025 Jul 15. |
| 40532064 | Derived | Alvarez-Bustos A, Coelho-Junior HJ, Calvani R, Rodriguez-Manas L, Tosato M, Cesari M, Cherubini A, Cruz-Jentoft AJ, Jonsson PV, Lattanzio F, Maggio M, Roller-Wirnsberger R, Ryznarova I, Schols AMWJ, Sieber CC, Sinclair AJ, Skalska A, Strandberg T, Tchalla A, Topinkova E, Vellas B, von Haehling S, Landi F, Marzetti E; SPRINTT consortium. Adherence to Physical Activity and Incident Mobility Disability in Older Adults With Mobility Limitations. J Cachexia Sarcopenia Muscle. 2025 Jun;16(3):e13870. doi: 10.1002/jcsm.13870. |
| 35545258 | Derived | Bernabei R, Landi F, Calvani R, Cesari M, Del Signore S, Anker SD, Bejuit R, Bordes P, Cherubini A, Cruz-Jentoft AJ, Di Bari M, Friede T, Gorostiaga Ayestaran C, Goyeau H, Jonsson PV, Kashiwa M, Lattanzio F, Maggio M, Mariotti L, Miller RR, Rodriguez-Manas L, Roller-Wirnsberger R, Ryznarova I, Scholpp J, Schols AMWJ, Sieber CC, Sinclair AJ, Skalska A, Strandberg T, Tchalla A, Topinkova E, Tosato M, Vellas B, von Haehling S, Pahor M, Roubenoff R, Marzetti E; SPRINTT consortium. Multicomponent intervention to prevent mobility disability in frail older adults: randomised controlled trial (SPRINTT project). BMJ. 2022 May 11;377:e068788. doi: 10.1136/bmj-2021-068788. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |