Designed and led by the Ageing, Sarcopenia and Multimorbidity Theme in the NIHR Newcastle BRC, REVITALISE is the first platform trial focused on sarcopenia, and will enable early-phase clinical studies of promising new treatments for sarcopenia, translating discoveries in the laboratory through into testing in patients.
Unlike traditional clinical trials that test a single treatment, REVITALISE uses a platform trial design, enabling multiple potential treatments to be tested within a single, flexible research framework. This approach allows the trial to adapt as evidence emerges, accelerating the identification of the most promising interventions.
Over time, REVITALISE will evaluate up to five different interventions, with 30 older participants with sarcopenia enrolled in each subtrial for a 12 week period. Participants will undergo detailed testing of their muscle function including muscle biopsies at the start and end of the trial to enable reserarchers to understand the mechanisms by which new treatments are working to improve muscle function
The first intervention being tested in REVITALISE is fisetin, a naturally occurring compound found in small amounts in fruits and vegetables such as strawberries, apples and onions.
Fisetin belongs to a group of compounds known as senolytics, which may help remove older, damaged cells that accumulate as we age. These “ageing cells” are thought to contribute to inflammation, muscle weakness and long term health conditions. If fisetin is able to remove these senescent cells from muscle, it could improve muscle health and function in later life, preventing or treating sarcopenia.
In line with NIHR Newcastle BRC’s commitment to inclusive, participant centred research, REVITALISE has been designed in collaboration with older people, who have advised on the best way to recruit participants, how to communicate about the trial, and what measurements would be useful to obtain in the trial. REVITALiSE has been designed to be as accessible as possible to older people with muscle weakness - all screening visits can take place in participants’ own homes, reducing burden and supporting involvement from people who might otherwise find research difficult to access.
Delivery of the study is supported by the Research Delivery Network (RDN) Ageing and MLTC Research Fellows, whose work is central to successful community based research.
Dr Claire McDonald, Co Chief Investigator for REVITALISE, said:
“REVITALiSE demonstrates what NIHR Newcastle BRC does best – combining innovative trial design with a strong focus on the needs of older people. This platform approach gives us the opportunity to learn quickly, while keeping participation straightforward and meaningful.”
Professor Miles Witham, Co Chief Investigator, added:
“Sarcopenia affects strength, mobility and independence for so many older people. Through REVITALiSE, the NIHR Newcastle BRC is leading research that not only tests promising treatments such as fisetin but also helps us understand the underlying biology of ageing muscle.”