Effect of a wearable-based individualised multidomain lifestyle intervention on cognitive and physical function in older adults at risk of decline (INSPIOR): a single-centre, open-label, randomised controlled trial.

Authors

Keisuke Sakurai, Ryo Tanaka, Joseph Ledsam, Izumi Shiraishi, Hiroyasu Kasahara, Saya Anzai, Miwa Watanabe, Momoko Funakawa, Saori Shimada, Tatsuya Goto, Riki Kawabata, Keiko Murasakino, Tomoko Kawaura, Noriko Inamura, Ko Kaneta, Satoru Kobayashi, Toshiyuki Nomura, Nori Karasawa, Takashi Matsumoto, Tomoki Taira, Toshihiro Ishiguro, Kazuyuki Kudo, Matthew J Thompson, Hiroki Kayama, Yukihiro Sugawara, Shin'ichi Warisawa, Tatsuhiro Hisatsune

Published in

EClinicalMedicine. Volume 100. Pages 104212. Epub Sep 23, 2026.

Abstract

Multidomain lifestyle programmes are the leading preventive approach to cognitive decline, but they rely on intensive face-to-face delivery that is hard to scale. We assessed whether an automated, wearable-based multidomain programme of activity, sleep, and optional nutrition prompts changed cognitive and physical function in at-risk older adults.
INSPIOR was a 6-month, single-centre, open-label, randomised controlled trial in Kashiwa, Japan. Adults aged 65-92 years with low body-mass index, pre-frailty, frailty, or sarcopenia-related decline were randomly assigned 1:1, in permuted blocks of four and without stratification, to the Fitbit-based intervention or an assessment-only control; allocation was not concealed and outcome assessors were not masked. Co-primary outcomes were the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), and skeletal muscle mass index (SMI), with no pre-specified hierarchy or multiplicity adjustment; analyses used intention-to-treat analysis of covariance with multiple imputation. This trial was registered with UMIN-CTR, UMIN000052707, and ClinicalTrials.gov, NCT06135740.
Between Nov 8, 2023, and Jul 31, 2024, 355 participants were randomly assigned to the intervention group (n = 178) or control group (n = 177); all were analysed. Adjusted between-group differences were 0·58 MoCA points (95% CI 0·03-1·13; p = 0·039; Holm-adjusted p = 0·12), 0·16 s (-5·07 to 5·40; p = 0·95) for TMT-A, 5·59 s (-3·88 to 15·05; p = 0·25) for TMT-B, and -0·01 kg/m² (-0·09 to 0·07; p = 0·88) for SMI. Mild skin irritation and dietary-recording stress occurred; no serious adverse event was intervention-related.
The intervention was associated with a small difference in a global cognitive screening score that did not survive multiplicity adjustment and is of uncertain clinical significance; the other two showed none. Larger, longer, masked trials are needed.
University of Tokyo-NH Foods Collaborative Research Programme, Google, Mitsui Fudosan.

PMID:
42831056
Bibliographic data and abstract were imported from PubMed on 05 Oct 2026.

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