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

NCT ID: NCT04223063

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2022-03-31

Brief Summary

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.

Detailed 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.

Conditions

Bladder Cancer; Urothelial Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise Intervention

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.

Group Type: EXPERIMENTAL

Exercise program

Intervention Type: BEHAVIORAL

As per the intervention arm

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise program

As per the intervention arm

Intervention Type: BEHAVIORAL

Other Intervention Names

Multimodal, home-based exercise program

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: collaborator

Ross Mason

OTHER

Sponsor Role: lead

Responsible Party

Ross Mason

Assistant Professor of Urology

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

21485

Identifier Type: -

Identifier Source: org_study_id