SarcopeniaSPRINTTNCT02582138
Multicomponent Intervention for Physical Frailty and Sarcopenia
A study testing Multicomponent intervention (MCI) and Healthy Aging Lifestyle Education (HALE) in people with Sarcopenia, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Multicomponent intervention (MCI) and Healthy Aging Lifestyle Education (HALE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Dec 2018
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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:
- Body mass index-adjusted appendicular lean mass (aLM; i.e., the sum of lean mass from both arms and legs): <0.789 in men, and <0.512 in women OR
- aLM <19.75 kg in men and <15.02 kg in women
- Willingness to be randomised to either intervention group and to follow the study protocol.
Who cannot join
- General
- Unable or unwilling to provide informed consent or accept randomisation to either study group.
- Plans to relocate out of the study area within the next 2 years or plans to be out of the study area for more than 6 consecutive weeks in the next year;
- Residence in long-term care;
- Household member enrolled in the study.
- Clinical conditions:
Show all 32Show fewer
- Current diagnosis of schizophrenia, other psychotic or bipolar disorder;
- Consumption of more than 14 alcoholic drinks per week;
- Difficulty communicating with the study personnel due to speech, language, or (non-corrected) hearing problems;
- Mini Mental State Examination lower than 24/30;
- Severe osteoarthritis (e.g., awaiting joint replacement) that would interfere with the ability to participate fully in either study arm;
- Cancer requiring treatment in the past 3 years, except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., early stage breast or prostate cancer);
- Lung disease requiring regular use of supplemental oxygen;
- Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents;
- Severe cardiovascular disease (including New York Heart Association class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, or uncontrolled angina)
- Upper and/or lower extremity amputation;
- Peripheral arterial disease Lériche-Fontaine 3 or 4;
- Parkinson's disease or other progressive neurological disorder;
- Renal disease requiring dialysis;
- Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline 400-metre walk test;
- Current participation in a structured exercise programme, physical therapy or cardiopulmonary rehabilitation;
- Current enrolment in another randomised clinical trial involving lifestyle, nutrition, or pharmaceutical interventions;
- Other medical, psychiatric, or behavioural factors that in the judgment of the principal investigator may interfere with the study participation or the ability to autonomously follow either the multicomponent or the healthy aging lifestyle education programmes;
- Other illness of such severity that life expectancy is expected to be less than 12 months;
- Clinical judgment concerning safety or non-compliance.
- Temporary exclusion criteria
- Uncontrolled hypertension (systolic blood pressure >200 mm Hg, or diastolic blood pressure >110 mm Hg);
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent hypoglycaemia;
- Hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- Serious cardiac conduction disorder (e.g., third-degree heart block), uncontrolled arrhythmia, new Q waves within the past 6 months or ST-segment depression (>3 mm) on the electrocardiogram;
- Myocardial infarction, major heart surgery (i.e., valve replacement or coronary bypass graft), stroke, deep vein thrombosis, or pulmonary embolism in the past 6 months;
- Use of growth hormone, oestrogens, progesterone, or testosterone supplementation in the past 3 months.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Catholic University of the Sacred Heart
Rome, Rome, 00168
Emanuele Marzetti, MD, PhD, +39 0630155559, emarzetti@live.com
Riccardo Calvani, PhD, +39 0630155559, riccardo.calvani@gmail.com
About this study
Official title: Sarcopenia and Physical fRailty IN Older People: Multi-componenT Treatment Strategies (SPRINTT)
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.
Read the detailed description
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.
- Conditions
- Sarcopenia
- Being tested
- Multicomponent intervention (MCI), Healthy Aging Lifestyle Education (HALE)
- Keywords
- physical frailty, sarcopenia, exercise, nutrition, information and communications technology
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- a daily total energy intake of 25-30 kcal/kg body weight;
- an average protein daily intake between 1.0 and 1.2 g/Kg/body weight.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent intervention (MCI) | Experimental | The multicomponent intervention will include a physical activity programme, a nutritional intervention and an information and communications intervention. Receives: Other: Multicomponent intervention (MCI) |
| 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. Receives: Other: Healthy Aging Lifestyle Education (HALE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of major mobility disability
Incident inability to complete the 400-metre walk test (incidence of major mobility disability)
Measured: 36 months
Secondary outcomes (22)
Changes in lower extremity physical performance
Changes in short physical performance battery (SPPB) summary score
Measured: 36 months
Changes in upper extremity muscle strength
Changes in handgrip strength test performance (kg)
Measured: 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)
Measured: 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)
Measured: 36 months
Changes in crude appendicular lean mass
Changes in crude in appendicular lean mass (kg) by Dual Energy X-Ray Absorptiometry
Measured: 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
Measured: 36 months
Persistent mobility disability
Inability to complete the 400-metre walk test at two consecutive semiannual visits
Measured: 36 months
Changes in body weight
Changes in body weight (kg)
Measured: 36 months
Changes in body mass index
Changes in body mass index (kg/m^2)
Measured: 36 months
Changes in mid-arm circumference
Changes in mid-arm circumference (cm)
Measured: 36 months
Changes in waist circumference
Changes in waist circumference (cm)
Measured: 36 months
Changes in hip circumference
Changes in hip circumference (cm)
Measured: 36 months
Changes in calf circumference
Changes in calf circumference (cm)
Measured: 36 months
Changes in nutritional status
Changes in Mini Nutritional Assessment-Short Form (MNA-SF) score
Measured: 36 months
Changes in cognitive function
Changes in Mini Mental State Examination (MMSE) score
Measured: 36 months
Changes in mood
Changes in 11-item Center for Epidemiological Studies - Depression (CES-D) scale score
Measured: 36 months
Incidence of self-reported falls
Number of falls assessed by questionnaires
Measured: 36 months
Incidence of injurious falls
Number of injurious falls assessed by questionnaires
Measured: 36 months
Changes in quality of life
Changes in EuroQoL-5D (EQ5D) score
Measured: 36 months
Changes in the use of healthcare services
Health economics questionnaire
Measured: 36 months
All-cause mortality
Mortality rate
Measured: 36 months
Cost effectiveness
Cost effectiveness analysis
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Bernabei, Catholic University of the Sacred Heart
- Investigators
- Francesco Landi, MD, PhD, Principal investigator, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582138
- Sponsor's protocol ID
- 115621
- Other IDs
- IMI-JU-09-2013-02
- Acronym
- SPRINTT
- Status last verified
- Feb 2017
- First submitted
- 8 Oct 2015
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 40669418Levati 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.
PubMed 40665144Alvarez-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.
PubMed 40532064Kerminen H, Jyvakorpi S, Urtamo A, Huhtala H, Ohman H, Calvani R, Marzetti E, Pitkala K, Strandberg T. Performance of the SARC-F, SARC-CalF, and calf circumference for sarcopenia case finding in community-dwelling older adults. Eur Geriatr Med. 2024 Dec;15(6):1817-1826. doi: 10.1007/s41999-024-01060-4. Epub 2024 Sep 19.
PubMed 39300055Bernabei 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.
PubMed 35545258
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia and Physical fRailty IN Older People: Multi-componenT Treatment Strategies (SPRINTT)
- ClinicalTrials.gov ID
- NCT02582138
- Acronym / sponsor ID
- SPRINTT / 115621
- Conditions
- Sarcopenia
- Keywords
- physical frailty, sarcopenia, exercise, nutrition, information and communications technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent intervention (MCI) | Experimental | Other: Multicomponent intervention (MCI)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 | Other: Healthy Aging Lifestyle Education (HALE)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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (32 listed)
- General
- Unable or unwilling to provide informed consent or accept randomisation to either study group.
- Plans to relocate out of the study area within the next 2 years or plans to be out of the study area for more than 6 consecutive weeks in the next year;
- Residence in long-term care;
- Household member enrolled in the study.
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 |
|---|---|---|
| Multicomponent intervention (MCI)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: * a daily total energy intake of 25-30 kcal/kg body weight; * an average protein daily intake between 1.0 and 1.2 g/Kg/body weight. 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. | Other | Multicomponent intervention (MCI) |
| Healthy Aging Lifestyle Education (HALE)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. | Other | Healthy Aging Lifestyle Education (HALE) |
Primary outcome
Incident of major mobility disability
Time frame: 36 months
Incident inability to complete the 400-metre walk test (incidence of major mobility disability)
22 secondary outcomes
Changes in lower extremity physical performance
Time frame: 36 months
Changes in upper extremity muscle strength
Time frame: 36 months
Changes in functional status (activities of daily living)
Time frame: 36 months
Changes in functional status (instrumental activities of daily living)
Time frame: 36 months
Changes in crude appendicular lean mass
Time frame: 36 months
Changes in body mass index-adjusted appendicular lean mass
Time frame: 36 months
Persistent mobility disability
Time frame: 36 months
Changes in body weight
Time frame: 36 months
Changes in body mass index
Time frame: 36 months
Changes in mid-arm circumference
Time frame: 36 months
Changes in waist circumference
Time frame: 36 months
Changes in hip circumference
Time frame: 36 months
Changes in calf circumference
Time frame: 36 months
Changes in nutritional status
Time frame: 36 months
Changes in cognitive function
Time frame: 36 months
Changes in mood
Time frame: 36 months
Incidence of self-reported falls
Time frame: 36 months
Incidence of injurious falls
Time frame: 36 months
Changes in quality of life
Time frame: 36 months
Changes in the use of healthcare services
Time frame: 36 months
All-cause mortality
Time frame: 36 months
Cost effectiveness
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Derived from this study: PubMed 40669418Coelho-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.
- Derived from this study: PubMed 40665144Levati 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.
- Derived from this study: PubMed 40532064Alvarez-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.
- Derived from this study: PubMed 39300055Kerminen H, Jyvakorpi S, Urtamo A, Huhtala H, Ohman H, Calvani R, Marzetti E, Pitkala K, Strandberg T. Performance of the SARC-F, SARC-CalF, and calf circumference for sarcopenia case finding in community-dwelling older adults. Eur Geriatr Med. 2024 Dec;15(6):1817-1826. doi: 10.1007/s41999-024-01060-4. Epub 2024 Sep 19.
- Derived from this study: PubMed 35545258Bernabei 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.
- 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.
Francesco Landi, MD, PhD principal investigator
Catholic University of the Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent intervention (MCI) and Healthy Aging Lifestyle Education (HALE) in people with Sarcopenia, 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 6 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 2 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emanuele Marzetti, MD, PhD (+39 06 3015 ext. 5559, emarzetti@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident of major mobility disability (time frame: 36 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 NCT02582138, which also lists 5 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 2 Feb 2017.