Effectiveness of a personalised 6-month programme on physical frailty in older patients treated for bladder or kidney cancer – FRAGECO program – multicenter, controlled, randomized study protocol

BACKGROUND: Older adults with bladder or kidney cancer are particularly vulnerable to functional decline and postoperative complications that can exacerbate frailty. Conventional care models focus mainly on surgery and postoperative recovery, with limited continuity of support, resulting in suboptimal long-term functional outcomes. The aim is to evaluate the effectiveness of a personalized 6-month care pathway on reducing physical frailty in older adults undergoing surgery for bladder or kidney cancer, compared with standard care. METHODS: FRAGECO is a multicenter, controlled, randomized trial includes a personalized intervention combining two weekly 60-minute adapted physical activity (APA) sessions for one month before and one month after surgery, integrating moderate-intensity endurance, strength, and balance exercises. Optional patient education addresses physical activity, nutrition, treatments, and fatigue. Patients are then referred to local Devices for Adapted Physical Activity Practice (DAPAP) for 12 weeks to support long-term adherence. The primary outcome is physical frailty at 6 months, assessed using the six-minute walk test (6MWT) as a proxy measure. Secondary outcomes include: frailty, nutritional status, memory, quality of life, fatigue, depression, muscular strength and balance. A qualitative analysis will explore barriers, facilitators, and contextual factors influencing implementation. DISCUSSION: The results of this study could be used to develop the management of older cancer patients in current practice in order to limit their post-operative frailty. Protocol version n°2 09/04/2025 Trial registration: ClinicalTrials.gov NCT07073703, registered on 10 July 2025, prior to the first participant enrolment, https://clinicaltrials.gov/study/NCT07073703 Recruitment started on 3 December 2025.