NCT02582138

Brief 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 people with physical frailty and sarcopenia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

2.9 years

First QC Date

October 8, 2015

Last Update Submit

February 1, 2017

Conditions

Sarcopenia

Keywords

physical frailtysarcopeniaexercisenutritioninformation and communications technology

Outcome Measures

Primary Outcomes (1)

  • Incident of major mobility disability

    Incident inability to complete the 400-metre walk test (incidence of major mobility disability)

    36 months

Secondary Outcomes (22)

  • Changes in lower extremity physical performance

    36 months

  • Changes in upper extremity muscle strength

    36 months

  • Changes in functional status (activities of daily living)

    36 months

  • Changes in functional status (instrumental activities of daily living)

    36 months

  • Changes in crude appendicular lean mass

    36 months

  • +17 more secondary outcomes

Study Arms (2)

Multicomponent intervention (MCI)

EXPERIMENTAL

The multicomponent intervention will include a physical activity programme, a nutritional intervention and an information and communications intervention.

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.

Other: Healthy Aging Lifestyle Education (HALE)

Interventions

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.

Multicomponent intervention (MCI)
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.

Healthy Aging Lifestyle Education (HALE)

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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)
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of the Sacred Heart

Rome, Rome, 00168, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 40669418DERIVED

  • 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.

    PMID: 40665144DERIVED

  • 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.

    PMID: 40532064DERIVED

  • 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.

    PMID: 35545258DERIVED

MeSH Terms

Conditions

SarcopeniaMotor Activity

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Study Officials

  • Francesco Landi, MD, PhD

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuele Marzetti, MD, PhD

CONTACT

+39 06 3015emarzetti@live.com

Riccardo Calvani, PhD

CONTACT

+39 06 3015riccardo.calvani@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Geriatrics

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 21, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

IT(1)