Exercise-based Pre-habilitation in Bladder Cancer Patients Prior to Radical Cystectomy: a Feasibility Study

Ross Mason

Status: Unknown

Conditions: Bladder Cancer; Urothelial Carcinoma

Treatments: Behavioral: Exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT04223063

21485

Details and patient eligibility

About

The purpose of this study is to explore the feasibility and efficacy of a 12-week, home-based exercise program in bladder cancer patients undergoing curative intent neoadjuvant chemotherapy and RC.

Full description

The investigators will seek to recruit 20 patients diagnosed with muscle invasive localized urothelial carcinoma of the bladder who are scheduled to receive neo-adjuvant chemotherapy prior to RC from the Queen Elizabeth Health Sciences center in Halifax, Nova Scotia. Participants will be randomly allocated to standard of care treatment versus standard of care plus a multimodal, home-based program including strength and endurance exercises. Outcomes measured will include feasibility data, patient outcomes, and post-surgical complications.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. confirmed diagnosis of localized muscle invasive urothelial carcinoma of the bladder (clinical stages cT2-4a, N0-1, M0);
2. treatment plan includes the administration of cisplatin-based systemic neoadjuvant chemotherapy prior to anticipated RC (typically four, 3-week cycles of cisplatin-based chemotherapy);
3. English fluency;
4. physician approval; and
5. participant willingness to participate in a 12-week, home-based exercise intervention.

Exclusion criteria

1. unstable or symptomatic cardiac or pulmonary disease, musculoskeletal injury or co-morbid disease that precludes ability to exercise; and
2. significant cognitive limitations.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Exercise Intervention

Experimental group

Description:

Participants allocated to the exercise intervention will engage in a multimodal, home-based program including strength and endurance exercises. Participants will initially be seen in person and instructed to begin a moderate-intensity (i.e., 3-4 on 10-point Borg Scale) walking (or preferred aerobic exercise) program for a minimum of 30 minutes/day, 3-5 days/week and perform strength exercises at least 2 days/week.

Treatment:

Behavioral: Exercise program

Control

No Intervention group

Description:

Participants allocated to the control group will not receive any formal exercise prescription or guidance, however they will be offered the opportunity to participate in a home-based intervention pending the completion of data collection.