Table 1

Outcome measures in the intervention and control group

Description of outcome	Assessment	Description of measure	T0a	T0b	T1	T2	T3
Primary outcome
Proportion of patients who develop one or more grade ≥2 perioperative complications within 90 days	Perioperative complications, grade ≥2 according to Clavien-Dindo classification	Number of grade ≥2 complication is abstracted from medical records				X	X
Secondary outcomes
Proportion of patients who develop one or more high-grade (≥3) complications, number of complications, length of hospital stay and readmissions within 90 days	Perioperative complications, grade ≥3 according to Clavien-Dindo classification, length of hospital stay, readmissions	Number of grade ≥3 complications, number of complications, length of hospital stay in days and readmissions abstracted from medical records				X	X
Cardiorespiratory fitness	Cardiopulmonary exercise test on a cycle ergometer using a ramp protocol40	Peak oxygen uptake (VO₂peak in mL/kg/min)	X		X
Physical functioning	Short physical performance battery84	Five items organised into three subscales of balance, walking speed and lower extremity muscle strength	X		X		X
Upper extremity muscle strength	Handgrip strength using a handheld dynamometer85	The maximum score of three attempts of both hands in kilogram (kg)	X		X		X
Lower extremity functional muscle strength	30-s sit-to-stand test86	The number of sit to stands within 30 s	X		X		X
Nutritional intake	24-hour recall	Protein (total gram) and caloric intake (total kcal)	X		X
Nutritional status	Patient-generated subjective global assessment short form87	Four items assessing weight (status), nutritional intake, symptoms and physical functioning	X	X	X	X	X
Nutritional status	Nil per mouth consumption during hospitalisation	The number of days after RC abstracted from medical records				X	X
Body composition	Bioelectrical impedance analysis	Body mass (kg), body height (cm), (subcutaneous) fat mass (%) and (upper limb) muscle mass (kg) are measured, and BMI (kg/m²)	X		X		X
Health-related quality of life	EORTC quality of life questionnaire core 3088	Thirty items, organised into five functional scales (physical, role, emotional, cognitive and social), three symptom scales (pain, fatigue and emesis), six items (dyspnoea, sleep disturbance, appetite loss, constipation, diarrhoea and financial impact), and an overall quality of life scale	X	X	X	X	X
Bladder cancer-related quality of life	EORTC muscle-invasive bladder cancer specific module89	Thirty items, assessing urinary symptoms, bowel symptoms, sexual functioning, urostomy problems, difficulties associated with the use of a catheter and body image	X	X	X	X	X
Anxiety and depression	Hospital Anxiety and Depression Scale37	Seven items assessing anxiety and seven items assessing depression	X	X	X	X	X
Fatigue	Multidimensional fatigue inventory90	Twenty items, categorised into five scales: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue	X	X	X	X	X
Physical activity	Short questionnaire to assess health-enhancing physical activity91	Eleven items, organised into four different physical activities measuring frequency, duration and intensity (physical activity to and from home, household activities, activities at work and physical activities performed during leisure time)	X	X	X	X	X
Tumour hypoxia and immune cell infiltration	Two tumour biopsies: from routine diagnostic investigation and from surgical tumour excision	Immunohistochemistry analysis will be performed for hypoxia and immune cell infiltration biomarkers using the laboratory of the Karolinska Institutet (Sweden) and their according protocols	X		X
Cost-effectiveness	EuroQol 5-dimension-5 levels44	Five items (dimensions) multiattribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression in five levels	X	X	X	X	X
	iMTA Medical Consumption Questionnaire42 and Productivity Costs Questionnaire43	Patient-reported productivity losses and medical consumption		X	X	X	X
	Healthcare costs	Medical activities abstracted from the management systems of the hospitals					X
Other outcomes
Socio-demographic and clinical data	Socio-demographic data, disease and treatment characteristics will be abstracted from medical records or reported by the patient	Patient reported: place of birth, sex, marital status, living and work situation, education, lifestyle variables and the self-administrated comorbidity questionnaire92 Medical records: birth month and year, date of diagnosis, date and type of treatment, type of urinary diversion, tumour characteristics, ASA score, WHO score	X
Socio-demographic and clinical data		Patient reported: smoking status	X	X	X	X	X
Coping mechanism	Sense of coherence questionnaire93	Thirteen items, categorised into three scales: comprehensibility, manageability and meaningfulness	X
Compliance to the intervention	Adherence rates	Patient reported: self-composed (activity) diary. Physical therapist: adherence of the physical exercise training intervention on standardised training session forms	X	X	X
Patient evaluation	Self-composed questionnaire	Patients in the intervention group: satisfaction with the programme and willingness to participate in focus group Patients in the control group: evaluate contamination Both groups: evaluation of possible post-surgical intervention					X
Non-participation	Self-composed questionnaire	Patient-reported outcomes: socio-demographic, health-related and bladder cancer-related quality of life, anxiety and depression, fatigue, physical activity, coping mechanism and reason(s) for not participating. Medical records: birth month and year, date of diagnosis, date and type of treatment, tumour characteristics, ASA score, WHO score	X

ASA, American Society of Anesthesiologists; BMI, body mass index; EORTC, European Organisation for Research and Treatment of Cancer; RC, radical cystectomy; VO₂peak, oxygen uptake at peak exercise.