Bernabei, R., Landi, F., Calvani, R., Cesari, M., Del Signore, S., Anker, S. D., Bejuit, R., Bordes, P., Cherubini, A., Cruz-Jentoft, A. J., Di Bari, M., Friede, T., Gorostiaga Ayestarán, C., Goyeau, H., Jónsson, P. V., Kashiwa, M., Lattanzio, F., Maggio, M., Mariotti, L., … Marzetti, E. (2022). Multicomponent intervention to prevent mobility disability in frail older adults: Randomised controlled trial (SPRINTT project). BMJ, e068788. https://doi.org/10.1136/bmj-2021-068788
Multicomponent intervention to prevent mobility disability in frail older adults : randomised controlled trial (SPRINTT project)
|Author:||Bernabei, Roberto1,2; Landi, Francesco1,2; Calvani, Riccardo1;|
1Fdn Policlin Univ Agostino Gemelli IRCCS, Rome, Italy.
2Univ Cattolica Sacro Cuore, Dept Geriatr & Orthopaed, Rome, Italy.
3Univ Milan, Dept Clin Sci & Community Hlth, Milan, Italy.
4IRCCS Ist Clin Sci Maugeri, Geriatr Unit, Milan, Italy.
5Bluecompanion, London, England.
6Charite Univ Med Berlin, Dept Cardiol, Berlin, Germany.
7Charite Univ Med Berlin, Berlin Inst Hlth, Ctr Regenerat Therapies, German Ctr Cardiovasc Res DZHK, Partner Site Berlin, Berlin, Germany.
8Sanofi Aventis R&D, Chilly Mazarin, France.
9IRCCS INRCA, Ancona, Italy.
10Hosp Univ Ramon y Cajal IRYCIS, Serv Geriatrla, Madrid, Spain.
11Univ Firenze, Geriatr Intens Care Med, Florence, Italy.
12Azienda Osped Univ Careggi, Florence, Italy.
13Univ Goettingen, Dept Med Stat, Med Ctr, Gottingen, Germany.
14German Ctr Cardiovasc Res DZHK, Partner Site Gottingen, Gottingen, Germany.
15Servier, Int Clin Trial Res Dept, Madrid, Spain.
16Univ Iceland, Landspitali Univ Hosp, Fac Med, Dept Geriatr, Reykjavik, Iceland.
17Astellas Pharma, Tokyo, Japan.
18Univ Parma, Dept Med & Surg, Parma, Italy.
19Univ Hosp Parma, Cognit & Motor Ctr, Med & Geriatr Rehabil Dept Parma, Parma, Italy.
20Novartis Inst Biomed Res, Translat Med, Cambridge, MA USA.
21Hosp Univ Getafe, Serv Geriatria, Getafe, Spain.
22Med Univ Graz, Dept Internal Med, Graz, Austria.
23Silesian Hosp Opava, Opava, Czech Republic.
24Boehringer Ingelheim Pharma GmbH & Co KG, Translat Med & Clin Pharmacol, Biberach, Germany.
25Univ Maastricht, NUTRIM Sch Nutr & Translat Res Metab, Dept Resp Med, Maastricht, Netherlands.
26Friedrich Alexander Univ Erlangen Nurnberg, Inst Biomed Aging, Nurnberg, Germany.
27Diabet Frail, Droitwich Spa, England.
28Uniwersytet Jagiellonski, Fac Med, Dept Internal Med & Gerontol, Coll Med, Krakow, Poland.
29Univ Helsinki, Helsinki, Finland.
30Helsinki Univ Hosp, Helsinki, Finland.
31Univ Oulu, Ctr Life Course Hlth Res, Oulu, Finland.
32Ctr Hosp Univ Limoges, Pole Gerontol Clin, Limoges, France.
33Univ Karlova Praze, Fac Med 1, Prague, Czech Republic.
34Ctr Hosp Univ Toulouse, Gerontopole, Toulouse, France.
35Univ Goettingen, Dept Cardiol & Pneumol, Med Ctr, Gottingen, Germany.
36Univ Florida, Inst Aging, Gainesville, FL USA.
37Novartis Inst Biomed Res, Translat Med, Basel, Switzerland.
|Online Access:||PDF Full Text (PDF, 0.6 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2022110964969
|Publish Date:|| 2022-11-09
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.
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3121 General medicine, internal medicine and other clinical medicine
This work was funded by a grant from the Innovative Medicines Initiative Joint Undertaking (IMI-JU 115621) , which included in-kind support by member companies of the European Federation of Pharmaceutical Industries and Associations (Sanofi-Aventis, Novartis, GlaxoSmithKline, Servier, Astellas Pharma, and Boehringer Ingelheim) . The funder had no role in the study design,data collection, data analysis, data interpretation, writing of the report, or decision to submit the article for publication.
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