SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly

Study Overview
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Brief Summary
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Sarcopenia is associated with lower prognosis in solid tumors, but this has not been studied in bladder carcinoma requiring cystectomy. According to EWGSOP recommendations, the diagnosis of sarcopenia is based on walking speed, grip strength and muscle mass. These three elements can easily be measured (specially muscle mass measurement by bioimpedencemetry or tomodensitometry). This cohort study will collect clinical complementary elements to better understand the associated factors present with sarcopenia, in order to prepare an interventional preoperative physical reconditioning study. The mobility measurement will be carried out by the QAPPA questionnaire (validated in French in the elderly) and the quantitative measurement of activity and rest hours during a week by a wrist actimeter. Standardized geriatric data will also be collected: ADL, IADL for autonomy, MMSE for cognitive status, nutritional status (% weight loss, BMI), pain, GDS15 for depression screening, updated Charlson Comorbidity Index to identify polypathology and The STOPP tool for potentially inappropriate medication. Post-operative morbidity mortality at 30 days will be evaluated according to Clavien-Dindo classification. Investigators will also evaluate 6 months geriatric complications : falls, loss of autonomy and decreased mobility and physical activity, cognitive degradation, undernutrition, institutionalization

Official Title
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SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly

Conditions
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Sarcopenia, Bladder Cancer

Intervention / Treatment
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* Diagnostic Test: sarcopenia and mobility measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed urothelial bladder carcinoma ( RTUV) indication of radical cystectomy Able, informed and with informed consent for the study affiliated to the social security system talking French Exclusion Criteria: Life expectancy <6 months other active malignant tumors or other severe concomitant chronic pathologies affecting the general condition of the patient and / or likely to limit compliance with the requirements of the study. treatments incompatible with the study: previous corticosteroid treatment prolonged for more than one month (induces iatrogenic sarcopenia).

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sarcopenic<br>sarcopenic status the day before cystectomy. | Diagnostic Test: sarcopenia and mobility measurement<br>* walking speed, grip strength and BIA. QAPPA questionnaire (validated in French in the elderly) and the objective measurement of the time of activity and rest on a week per wrist actimeter. Comprehensive Geriatric Assessment<br>|
| Other: not sarcopenic<br>sarcopenic status the day before cystectomy. | Diagnostic Test: sarcopenia and mobility measurement<br>* walking speed, grip strength and BIA. QAPPA questionnaire (validated in French in the elderly) and the objective measurement of the time of activity and rest on a week per wrist actimeter. Comprehensive Geriatric Assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative morbidity | evaluated according to Clavien-Dindo classification | at 30 days | 
| post-operative mortality |  | at 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative complications | Impact of dependancy (PS / ADL / IADL) | 8 months | 
| post-operative complications | physical activity scores (QAPPA) Questionnaire d'activité physique pour les personnes âgées in French validated in French population - total score is used | 8 months | 
| post-operative complications | physical performance (PBP) | 8 months | 
| post-operative complications | fatigue (BFI) Brief Fatigue Inventory questionnaire | 8 months | 
| post-operative complications | history of fall | 8 months | 
| post-operative complications | pain (visual analogic scale for pain 0 to 10) | 8 months | 
| post-operative complications | hours of mobility (actimetry) | 8 months | 
| post-operative complications | hours of daily rest (actimetry) measured during 3 consecutives days | 8 months | 
| post-operative complications | Actimetry | 8 months | 
| post-operative complications | nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme ) | 8 months | 
| post-operative complications | cognitive status (normal or not) | 8 months | 
| post-operative complications | polymedication (≥5 / day) | 8 months | 
| post-operative complications | comorbidities (updated charlson) | 8 months | 
| post-operative complications | inappropriate prescriptions (STOPP) | 8 months | 
| impedancemetric value | Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value | 2 months | 
| sarcopenic status | evolution of sarcopenic status | between baseline; preoperative and at 6 months post-operative | 
| quality of life scores | EORTC QLQ-ELD14 (assessment of health-related quality of life elderly patients with cancer with 14 items) | preoperative and 6-month post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, elderly