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Multicomponent intervention to prevent mobility disability in frail older adults: randomised controlled trial (SPRINTT project)
R. Bernabei, F. Landi, R. Calvani, M. Cesari, S. Del Signore, SD. Anker, R. Bejuit, P. Bordes, A. Cherubini, AJ. Cruz-Jentoft, M. Di Bari, T. Friede, C. Gorostiaga Ayestarán, H. Goyeau, PV. Jónsson, M. Kashiwa, F. Lattanzio, M. Maggio, L....
Language English Country Great Britain
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
NLK
Europe PubMed Central
from 1981
ProQuest Central
from 1996-01-01
Nursing & Allied Health Database (ProQuest)
from 1996-01-01
Health & Medicine (ProQuest)
from 1996-01-01
- MeSH
- Frailty * MeSH
- Frail Elderly MeSH
- Humans MeSH
- Child, Preschool MeSH
- Independent Living MeSH
- Sarcopenia * prevention & control MeSH
- Aged MeSH
- Hand Strength MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Child, Preschool MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
OBJECTIVE: To determine whether a multicomponent intervention based on physical activity with technological support and nutritional counselling prevents mobility disability in older adults with physical frailty and sarcopenia. DESIGN: Evaluator blinded, randomised controlled trial. SETTING: 16 clinical sites across 11 European countries, January 2016 to 31 October 2019. PARTICIPANTS: 1519 community dwelling men and women aged 70 years or older with physical frailty and sarcopenia, operationalised as the co-occurrence of low functional status, defined as a short physical performance battery (SPPB) score of 3 to 9, low appendicular lean mass, and ability to independently walk 400 m. 760 participants were randomised to a multicomponent intervention and 759 received education on healthy ageing (controls). INTERVENTIONS: The multicomponent intervention comprised moderate intensity physical activity twice weekly at a centre and up to four times weekly at home. Actimetry data were used to tailor the intervention. Participants also received personalised nutritional counselling. Control participants received education on healthy ageing once a month. Interventions and follow-up lasted for up to 36 months. MAIN OUTCOME MEASURES: The primary outcome was mobility disability (inability to independently walk 400 m in <15 minutes). Persistent mobility disability (inability to walk 400 m on two consecutive occasions) and changes from baseline to 24 and 36 months in physical performance, muscle strength, and appendicular lean mass were analysed as pre-planned secondary outcomes. Primary comparisons were conducted in participants with baseline SPPB scores of 3-7 (n=1205). Those with SPPB scores of 8 or 9 (n=314) were analysed separately for exploratory purposes. RESULTS: Mean age of the 1519 participants (1088 women) was 78.9 (standard deviation 5.8) years. The average follow-up was 26.4 (SD 9.5) months. Among participants with SPPB scores of 3-7, mobility disability occurred in 283/605 (46.8%) assigned to the multicomponent intervention and 316/600 (52.7%) controls (hazard ratio 0.78, 95% confidence interval 0.67 to 0.92; P=0.005). Persistent mobility disability occurred in 127/605 (21.0%) participants assigned to the multicomponent intervention and 150/600 (25.0%) controls (0.79, 0.62 to 1.01; P=0.06). The between group difference in SPPB score was 0.8 points (95% confidence interval 0.5 to 1.1 points; P<0.001) and 1.0 point (95% confidence interval 0.5 to 1.6 points; P<0.001) in favour of the multicomponent intervention at 24 and 36 months, respectively. The decline in handgrip strength at 24 months was smaller in women assigned to the multicomponent intervention than to control (0.9 kg, 95% confidence interval 0.1 to 1.6 kg; P=0.028). Women in the multicomponent intervention arm lost 0.24 kg and 0.49 kg less appendicular lean mass than controls at 24 months (95% confidence interval 0.10 to 0.39 kg; P<0.001) and 36 months (0.26 to 0.73 kg; P<0.001), respectively. Serious adverse events occurred in 237/605 (39.2%) participants assigned to the multicomponent intervention and 216/600 (36.0%) controls (risk ratio 1.09, 95% confidence interval 0.94 to 1.26). In participants with SPPB scores of 8 or 9, mobility disability occurred in 46/155 (29.7%) in the multicomponent intervention and 38/159 (23.9%) controls (hazard ratio 1.25, 95% confidence interval 0.79 to 1.95; P=0.34). CONCLUSIONS: A multicomponent intervention was associated with a reduction in the incidence of mobility disability in older adults with physical frailty and sarcopenia and SPPB scores of 3-7. Physical frailty and sarcopenia may be targeted to preserve mobility in vulnerable older people. TRIAL REGISTRATION: ClinicalTrials.gov NCT02582138.
1st Faculty of Medicine Univerzita Karlova Praha Prague Czech Republic
Department of Cardiology and Pneumology University of Goettingen Medical Centre Goettingen Germany
Department of Clinical Sciences and Community Health Università di Milano Milan Italy
Department of Geriatrics and Orthopaedics Università Cattolica del Sacro Cuore Rome Italy
Department of Internal Medicine Medizinische Universität Graz Graz Austria
Department of Medical Statistics University of Goettingen Medical Centre Goettingen Germany
Department of Medicine and Surgery Università degli Studi di Parma Parma Italy
Diabetes Frail Droitwich Spa UK
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Geriatric Unit IRCCS Istituti Clinici Scientifici Maugeri Milan Italy
German Centre for Cardiovascular Research partner site Göttingen Goettingen Germany
Gérontopôle Centre Hospitalier Universitaire de Toulouse Toulouse France
Institute on Aging University of Florida Gainesville FL USA
International Clinical Trial Research Department Servier Madrid Spain
Pôle Gérontologie Clinique Centre Hospitalier Universitaire de Limoges Limoges France
Sanofi Aventis R and D Chilly Mazarin France
Servicio de Geriatría Hospital Universitario de Getafe Getafe Spain
Servicio de Geriatría Hospital Universitario Ramón y Cajal IRYCIS Madrid Spain
Silesian Hospital in Opava Opava Czech Republic
Translational Medicine Novartis Institutes for Biomedical Research Basel Switzerland
Translational Medicine Novartis Institutes for Biomedical Research Cambridge MA USA
University of Helsinki and Helsinki University Hospital Helsinki Finland
University of Oulu Centre for Life Course Health Research Oulo Finland
References provided by Crossref.org
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