## Protocol Section
### Identification Module
**NCT ID:** NCT06416319

**Acronym:** PreAct

**Brief Title:** Preoperative Physical Activity Improvement With the Use of Activity Trackers Before Radical Cystectomy (PreAct)

**Official Title:** Preoperative Physical Activity Improvement With the Use of Activity Trackers in Patients Undergoing Radical Cystectomy for Bladder Cancer: A Randomized Controlled Trial (PreAct)

#### Organization Study ID Info
**ID:** 2021-677
#### Organization
**Class:** OTHER
**Full Name:** Universitätsmedizin Mannheim
### Status Module
#### Completion Date
**Date:** 2026-03-14

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03-14

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-03-14

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-05
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Dr. Rolf M. Schwiete Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitätsmedizin Mannheim

#### Responsible Party

**Investigator Affiliation:** Universitätsmedizin Mannheim

**Investigator Full Name:** Karl-Friedrich Kowalewski

**Investigator Title:** Managing Senior Physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A bicentric, open-label randomised controlled trial (RCT) is planned to investigate whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy leads to a preoperative increase in participants' physical activity (number of steps per day) up to the day of radical cystectomy.

**Detailed Description:** The goal of the PreAct study is to test whether the use of fitness wristbands in a defined preoperative period prior to radical cystectomy with a daily activity goal and feedback on the achievement of this goal improves the participants' physical activity up to the day of radical cystectomy.

In addition to the fitness tracker, we provide each patient with a smartphone. For each fitness tracker a separate account in a fitness application is set up for (e.g. name: tracker1.0 with the corresponding e-mail address and password). Neither the patients in the Daily activity Goal and Feedback arm nor the No Daily Activity Goal or Feedback arm receive the access data to the accounts. However, the patients in the intervention group receive the access PIN for the smartphone. On this smartphone a messaging service and the fitness application are installed. The patient thus receives, for example the wristband tracker1.0, which is registered with the corresponding access data in the fitness application of the smartphone given to them. For the entire preoperative period, the Bluetooth function on the smartphone must always stay activated so that the fitness application and the fitness tracker are continuously connected to each other. A detailed description of the timing and implementation of the intervention are described in "Study design" and "Arm and Interventions".

### Conditions Module

**Conditions:**

- Bladder Cancer

- Bladder Neoplasm

- Bladder Urothelial Carcinoma

**Keywords:**

- Cystectomy

- Preoperative Exercise

- Fitness Trackers

- Exercise

- Frailty

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Participants with an indication for radical cystectomy are included in this study. Recruitment, including eligibility criteria testing and randomized allocation to the intervention or control group, will take place on the day of premedication approximately 7 to 10 days prior to surgery. This period represents the prehabilitation period.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 164

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The participants in the Daily Activity Goal and Feedback arm receive a defined daily activity goal in the form of a defined number of steps, feedback on the achievement of this goal, and push-up notifications sent directly to the wristband to encourage them to remain active.

**Intervention Names:**

- Device: Daily Activity Goal and Feedback

**Label:** Daily Activity Goal and Feedback

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The display of the fitness wristbands of the No Daily Activity Goal or Feedback arm is covered up. The participants in this arm neither receive a daily activity goal nor get feedback on the achievement of the activity goal/push-up notifications.

**Label:** No Daily Activity Goal or Feedback

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Daily Activity Goal and Feedback

**Description:** The daily activity target is a fixed number of steps. The exact number of steps is determined beforehand as part of the case number planning in a pilot study with ten participants and adjusted if necessary. The activity target we suggest is 8000 steps. In addition, the participants receive feedback several times a day about the steps needed to reach the goal and whether they have ultimately reached the daily goal.

**Name:** Daily Activity Goal and Feedback

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Average daily step count measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.

**Measure:** Number of steps per day

**Time Frame:** Participants' daily step count is recorded on the day of surgery when the fitness tracker is put down.

#### Secondary Outcomes

**Description:** Total number of steps measured by the fitness tracker during the period of prehabilitation 7 to 10 days before surgery.

**Measure:** Total number of steps

**Time Frame:** Participants' total number of steps is recorded on the day of surgery when the fitness tracker is put down.

**Description:** The postoperative physical activity of the participants measured by the average number of steps per day and in total on postoperative days 1 to 3. Neither arm will receive a daily activity goal. However, the fitness trackers of the No Daily Activity Goal or Feedback arm are still covered.

**Measure:** Postoperative physical activity

**Time Frame:** Morning of postoperative day 4 at 7 PM

**Description:** Postoperative complications measured by the Comprehensive Classification Index (CCI), on a scale from 0 (no complications) to 100 (death), (Slankamenac, Graf et al. 2013) and the Clavien-Dindo Classification (CDC), which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the normal postoperative course, the highest grade indicating death (Clavien, Barkun et al. 2009):

CDC ≥ 3a corresponding to a CCI ≥ 26.2 defined as "severe complications" including CDC = 5 and CCI = 100 defined as "patient's death" and the total number of complications

**Measure:** Postoperative Complications

**Time Frame:** On postoperative day 30 and 90

**Description:** In minutes, incision - surgical incision closure

**Measure:** Operating time

**Time Frame:** On the day of surgery

**Description:** In millilitres

**Measure:** Blod loss

**Time Frame:** On the day of surgery

**Description:** Number of red blood cell concentrates, platelet concentrates, frozen fresh plasma

**Measure:** Required transfusion of blood products

**Time Frame:** On the day of surgery

**Description:** Yes or no

**Measure:** Feasibility of the planned urinary diversion

**Time Frame:** On the day of surgery

**Description:** If the planned urinary diversion is not feasible

**Measure:** Conversion rate

**Time Frame:** On the day of surgery

**Description:** SF-36: Health-related quality of life (Scale 0 - 100: The higher the score, the lower the disability. A score of 100 corresponds to no disability)

**Measure:** Patient Reported Outcome Measures (PROMs)

**Time Frame:** On the day of randomization at the premedication appointment and on the day of discharge which is on average 2 weeks after the surgery and postoperative day 30 and 90

**Description:** LOS measured by the number of days spent in the hospital after surgery until discharge

**Measure:** Length of hospital stay (LOS)

**Time Frame:** On the day of discharge which is on average 2 weeks after the surgery

**Description:** Readmissions due to a complication of the radical cystectomy

**Measure:** Readmission rate

**Time Frame:** On postoperative day 90 if occured

**Description:** Reoperation due to a complication of the radical cystectomy

**Measure:** Reoperation rate

**Time Frame:** On postoperative day 90 if occured

**Description:** Days spent in the ICU after surgery

**Measure:** Length of stay in the intensive care unit (ICU)

**Time Frame:** On postoperative day 90 if occured

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Planned radical cystectomy with bilateral pelvic lymphadenectomy and one of the different forms of urinary diversion (continent vs. incontinent; orthotopic vs. heterotopic) in patients with bladder cancer
* Participants age ≥ 18 years and capacity to consent
* Mobile participant who is not dependent on a walking aid
* The participant declares his or her consent to participate in this study by signing and dating the informed consent form prior to the surgical procedure

Exclusion Criteria:

* Karnofsky performance status scale ≤ 70% (with 70%: Care for self. Unable to carry on normal activity or to do active work (Ambulatory and capable of all selfcare but unable to carry out any work activities). ) (Range: 0 - 100 percent with 0 percent "participant´s death" and 100 percent "no disabilities"
* ASA Physical Status Classification: ASA \> 3 (3: A patient with severe systemic disease)
* ASA 1, 2, 3 if acute or chronic diseases of the musculoskeletal system or the central nervous system are involved that result in a symptomatic restriction of motor and / or, in the last case, neurological function (healing ruptures and fractures, Parkinson's disease, multiple sclerosis, etc.)
* Emergency intervention

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** karl-friedrich.kowalewski@umm.de

**Name:** Karl-Friedrich Kowalewski, PD Dr. med.

**Phone:** 0152-53404943

**Role:** CONTACT

**Contact 2:**

**Email:** johanneskilz@stud.uni-heidelberg.de

**Name:** Johannes Kilz

**Phone:** 0162-5297396

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Mannheim

**Contacts:**

***Contact 1:***

- **Email:** karl-friedrich-kowalewski@umm.de

- **Name:** Karl-Friedrich Kowalewski, M.D., M.Sc.

- **Role:** CONTACT

***Contact 2:***

- **Name:** Karl-Friedrich Kowalewski, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Germany

**Facility:** Department of Urology, University Medical Center Mannheim, University of Heidelberg

**State:** Baden-Württemberg

**Status:** RECRUITING

**Zip:** 68167

**Location 2:**

**City:** München

**Contacts:**

***Contact 1:***

- **Email:** maximilian.kriegmair@ukmp.de

- **Name:** Maximilian C. Kriegmair, M.D.

- **Role:** CONTACT

**Country:** Germany

**Facility:** Urologische Klinik München Planegg (UKMP)

**State:** Bayern

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Urology, University Medical Center Mannheim, Heidelberg University

**Name:** Karl-Friedrich Kowalewski, PD Dr. med

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000001745

- Term: Urinary Bladder Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M1175

- Name: Frailty

- Relevance: LOW

- As Found: Unknown

- ID: M5030

- Name: Urinary Bladder Neoplasms

- Relevance: HIGH

- As Found: Bladder Cancer

- ID: M5551

- Name: Carcinoma, Transitional Cell

- Relevance: LOW

- As Found: Unknown

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M5026

- Name: Urinary Bladder Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5693

- Name: Transitional Cell Carcinoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001749

- Term: Urinary Bladder Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
