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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03362801
Acronym
SAMPHYR
Enrollment
69
Registered
2017-12-05
Start date
2017-10-30
Completion date
2026-02-01
Last updated
2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Sarcopenia

Keywords

physical activity, elderly

Brief summary

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

Interventions

DIAGNOSTIC_TESTsarcopenia and mobility measurement

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

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
post-operative morbidityat 30 daysevaluated according to Clavien-Dindo classification
post-operative mortalityat 30 days

Secondary

MeasureTime frameDescription
post-operative complications8 monthsImpact of dependancy (PS / ADL / IADL)
impedancemetric value2 monthsConcordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value
sarcopenic statusbetween baseline; preoperative and at 6 months post-operativeevolution of sarcopenic status
quality of life scorespreoperative and 6-month post-operativeEORTC QLQ-ELD14 (assessment of health-related quality of life elderly patients with cancer with 14 items)

Countries

France

Contacts

Primary Contactfrançois fournel
fournel-f@chu-caen.fr+33231065488
Backup Contacthelene legros
legros-h@chu-caen.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026