Physical Therapy in Pre-cystectomy Patients

Not Applicable

Recruiting

• Conditions: Bladder Cancer
• Interventions: Other: A personally tailored exercise program

• Registration Number: NCT05978570
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

This single-site, non-randomized, interventional study evaluates the impact of a physical therapy consultation for patients with bladder cancer scheduled for radical cystectomy (RC). The purpose of this study is to investigate whether consultation with a physical therapist and the development of a personally tailored exercise program in the pre-cystectomy period for patients with bladder cancer will result in reduced post-operative complications, morbidity, length of inpatient stay, improve readmission 30-day and 90-day and improve 90-day mortality. This study will be partially retrospective (pre-implementation of a physical therapy consultation order) and partially prospective.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-07
• Study Start: 2023-08-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-02-18
• Study Completion: 2025-02-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Age ≥ 18 years at the time of bladder cancer diagnosis
2. History of bladder cancer
3. Performance of radical cystectomy

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Exclusion Criteria

1. No history of bladder cancer or radical cystectomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A personally tailored exercise	A personally tailored exercise program	A personally tailored exercise program will be offered to the participants after the Physical Therapy assessment, before the surgery.

Primary Outcome Measures

Name	Time	Method
Thirty-day readmission rates	Up to 30 days after the date of cystectomy	Thirty-day readmission rates will be defined as the comparison of the number of hospital admission after physical therapy consultation and tailored exercises and historical hospital admission data.

Secondary Outcome Measures

Name	Time	Method
Acute care length of stay	Starting to the exercises to up to 90 days after the date of cystectomy	Acute care length of stay will be defined as comparing number of hospital day stay after physical therapy consultation and tailored exercises and historical hospital admission data.
The proportion of individuals who received a physical therapy consultation	1 day (the date of cystectomy)	The feasibility of implementing a physical therapy consultation and tailored exercise program in the pre-cystectomy treatment pathway will be determined by calculating the proportion of individuals who received a physical therapy consultation in the prospective group.
Mortality rates	Up to 90 days after the date of cystectomy	Mortality rates will be defined as the comparison of the number of subjects who died after physical therapy consultation and tailored exercises and historical hospital admission data.
Ninety-day readmission rates	Up to 90 days after the date of cystectomy	Ninety-day readmission rates will be defined as the comparison of the number of hospital admission after physical therapy consultation and tailored exercises and historical hospital admission data.
Post-cystectomy complication types and rates	Up to 90 days after the date of cystectomy	Post-cystectomy complication types and rates will be defined as comparison of the numbers and types of complications after physical therapy consultation with tailored exercises and historical data.

Trial Locations

Locations (1)

Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States