Bladder CancerNCT01840137
Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer
A study testing Baseline Strength Test and Exercise in people with Bladder Cancer, run by University of Michigan at 1 site in United States.
Trial summary
The development of clinically relevant and scalable exercise interventions in older cystectomy patients may have an impact upon: Patients: Exercise interventions may improve patient outcomes, including quality of life and avoidance of skilled nursing facilities. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Baseline Strength Test and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must have biopsy-proven bladder cancer.
- Patients age ≥60, diagnosed with bladder cancer with planned cystectomy and urinary diversion, +/- neoadjuvant chemotherapy.
- The patient must be able to communicate and understand/complete forms/instructions, and be able to provide informed written consent prior to enrollment. Patients may have the assistance of an interpreter or surrogate when completing forms/surveys as needed.
- Karnofsky performance status ≥70 with the ability to walk unassisted.
- Sedentary baseline lifestyle, with an average of <180 minutes/week of moderate-intensity aerobic activity.
- Attending surgeon clearance to undergo a supervised exercise training program.
Who cannot join
- Contraindication to exercise training, such as skeletal metastases, symptomatic coronary artery disease, severe anemia, or any condition limiting their ability to participate in an exercise training program.
- Patients who require surgery sooner than 28 days from enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
The development of clinically relevant and scalable exercise interventions in older cystectomy patients may have an impact upon:
- Patients: Exercise interventions may improve patient outcomes, including quality of life and avoidance of skilled nursing facilities.
- Clinicians: Proving the safety and feasibility of targeted interventions in older surgical patients may facilitate the development of clinically relevant preoperative interventions suitable for wider study and implementation.
- Payers: Improved surgical outcomes among high risk surgical patients will be associated with significant cost savings.
- Researchers: Targeted and well controlled studies focusing on improving surgical outcomes through exercise may provide insight into relationships between patient factors, surgical stressors and outcomes. Ultimately, such work may lead to novel clinical approaches to optimize patients for surgery.
The investigators will study the effects of preoperative exercise training on cystectomy patients, specifically targeting increasing functional capacity and muscular strength. Prior to conducting a more extensive, multi-center, randomized-controlled trial, the feasibility, safety, and initial efficacy of preoperative exercise in cystectomy patients must be determined. To address this issue, the investigators will complete a trial of rehabilitation in cystectomy patients at the University of Michigan.
- Conditions
- Bladder Cancer
- Being tested
- Baseline Strength Test, Exercise
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline Strength TestOther
A symptom limited submaximal cardiopulmonary exercise test to estimate the subject's exercise capacity.
ExerciseOther
Treadmill and muscle exercises.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | The progressive, pre-operative exercise training program includes 3 supervised exercise sessions per week for 4 weeks. The first week of training will include an acclimation period accomplished via a ramping protocol. Subjects will warm-up on a treadmill for 5-minutes. Subjects will then complete 1 set of 15 repetitions exercising 8 major muscle groups during week one; during week #2 they will complete 2 sets with a goal of at least 12 repetitions; if subjects reach 15 repetitions on the second set, the resistance will be increased by 10% at the next training session to ensure progression. After completion of the resistance training portion of each session, subjects will walk on a treadmill for 30 minutes at a low/moderate intensity followed by a 5 minutes cool-down period. Receives: Other: Baseline Strength Test; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess whether a pre-operative exercise training program (Prehabilitation) for elderly patients undergoing cystectomy for bladder cancer will lower their post-operative 90-day hospital readmission rate.
The study will compare the readmission rate of 70 recruited prehabilitation patients to the historic readmission rates from our institution and the published literature. Readmission will be defined as an admission to any acute care hospital after initial discharge from the immediate post-operative stay within 90 days of surgery. Visits to emergency rooms or urgent, unscheduled outpatient evaluations will be tracked, but will not count as a readmission. We will also track instances in which patients experience multiple re-admissions within 90 days of surgery, but for the purposes of this study, multiple re-admissions for an individual patient will only count as a single readmission event.
Measured: 3 Years
Secondary outcomes (6)
Determine the efficacy of prehabilitation on improving functional capacity and strength from baseline levels.
A submaximal exercise test and 6 minute walk test will be used to assess the maximal rate of oxygen utilization and functional capacity at baseline and at the conclusion of the intervention period. Muscular strength will be evaluated using volume loading.
Measured: 3 Years
Composite of measures assessing the effects of prehabilitation on peri-operative cystectomy complications, resource utilization, patient reported outcomes, and functional status.
Early (within 30 days of surgery) and late (between 31 and 90 days of surgery) complications, length of hospital stay, resource utilization (emergency room visits, need for sub-acute rehabilitation or nursing home stays, and the costs associated with this additional care) and post-operative outcomes, such as functional capacity and quality of life, will be evaluated and compared to historic data available in the published literature.
Measured: 3 years
Evaluate safety for a prehabilitation program in elderly cystectomy patients.
The endpoint for safety is the prevalence of adverse events during study-related assessments and exercise training sessions.
Measured: 3 Years
Rates of attrition for a prehabilitation program in elderly cystectomy patients.
Study attrition will be the rate at which patients drop out of the study.
Measured: 3 Years
Rates of adherence for a prehabilitation program in elderly cystectomy patients.
Study adherence will be the percentage of prescribed exercise sessions each participant completes during the treatment period.
Measured: 3 Years
Rates of accrual for a prehabilitation program in elderly cystectomy patients.
Track the study recruitment rate and, once patients have been screened by the study team and approached to participate, note the reasons that patients who choose not to participate give for their refusal (personal preference, medical comorbidities/deconditioning, perceived program intensity, time commitment for the study protocol, travel distance or lack of consistent means of travel).
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionApr 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Montgomery, University of Michigan
- Investigators
- Jeffrey S. Montgomery, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840137
- Sponsor's protocol ID
- HUM00051581
- Status last verified
- Aug 2019
- First submitted
- 9 Apr 2013
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Prehabilitation in Vulnerable Patients Undergoing Cystectomy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT01840137
- Acronym / sponsor ID
- HUM00051581
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The development of clinically relevant and scalable exercise interventions in older cystectomy patients may have an impact upon:
- Patients: Exercise interventions may improve patient outcomes, including quality of life and avoidance of skilled nursing facilities.
- Clinicians: Proving the safety and feasibility of targeted interventions in older surgical patients may facilitate the development of clinically relevant preoperative interventions suitable for wider study and implementation.
- Payers: Improved surgical outcomes among high risk surgical patients will be associated with significant cost savings.
- Researchers: Targeted and well controlled studies focusing on improving surgical outcomes through exercise may provide insight into relationships between patient factors, surgical stressors and outcomes. Ultimately, such work may lead to novel clinical approaches to optimize patients for surgery.
The investigators will study the effects of preoperative exercise training on cystectomy patients, specifically targeting increasing functional capacity and muscular strength. Prior to conducting a more extensive, multi-center, randomized-controlled trial, the feasibility, safety, and initial efficacy of preoperative exercise in cystectomy patients must be determined. To address this issue, the investigators will complete a trial of rehabilitation in cystectomy patients at the University of Michigan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: Baseline Strength Test, Other: ExerciseThe progressive, pre-operative exercise training program includes 3 supervised exercise sessions per week for 4 weeks. The first week of training will include an acclimation period accomplished via a ramping protocol. Subjects will warm-up on a treadmill for 5-minutes. Subjects will then complete 1 set of 15 repetitions exercising 8 major muscle groups during week one; during week #2 they will complete 2 sets with a goal of at least 12 repetitions; if subjects reach 15 repetitions on the second set, the resistance will be increased by 10% at the next training session to ensure progression. After completion of the resistance training portion of each session, subjects will walk on a treadmill for 30 minutes at a low/moderate intensity followed by a 5 minutes cool-down period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have biopsy-proven bladder cancer.
- Patients age ≥60, diagnosed with bladder cancer with planned cystectomy and urinary diversion, +/- neoadjuvant chemotherapy.
- The patient must be able to communicate and understand/complete forms/instructions, and be able to provide informed written consent prior to enrollment. Patients may have the assistance of an interpreter or surrogate when completing forms/surveys as needed.
- Karnofsky performance status ≥70 with the ability to walk unassisted.
- Sedentary baseline lifestyle, with an average of <180 minutes/week of moderate-intensity aerobic activity.
Key exclusion criteria (2 listed)
- Contraindication to exercise training, such as skeletal metastases, symptomatic coronary artery disease, severe anemia, or any condition limiting their ability to participate in an exercise training program.
- Patients who require surgery sooner than 28 days from enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline Strength TestA symptom limited submaximal cardiopulmonary exercise test to estimate the subject's exercise capacity. | Other | Prehabilitation |
| ExerciseTreadmill and muscle exercises. | Other | Prehabilitation |
Primary outcome
Assess whether a pre-operative exercise training program (Prehabilitation) for elderly patients undergoing cystectomy for bladder cancer will lower their post-operative 90-day hospital readmission rate.
Time frame: 3 Years
The study will compare the readmission rate of 70 recruited prehabilitation patients to the historic readmission rates from our institution and the published literature. Readmission will be defined as an admission to any acute care hospital after initial discharge from the immediate post-operative stay within 90 days of surgery. Visits to emergency rooms or urgent, unscheduled outpatient evaluations will be tracked, but will not count as a readmission. We will also track instances in which patients experience multiple re-admissions within 90 days of surgery, but for the purposes of this study, multiple re-admissions for an individual patient will only count as a single readmission event.
6 secondary outcomes
Determine the efficacy of prehabilitation on improving functional capacity and strength from baseline levels.
Time frame: 3 Years
Composite of measures assessing the effects of prehabilitation on peri-operative cystectomy complications, resource utilization, patient reported outcomes, and functional status.
Time frame: 3 years
Evaluate safety for a prehabilitation program in elderly cystectomy patients.
Time frame: 3 Years
Rates of attrition for a prehabilitation program in elderly cystectomy patients.
Time frame: 3 Years
Rates of adherence for a prehabilitation program in elderly cystectomy patients.
Time frame: 3 Years
Rates of accrual for a prehabilitation program in elderly cystectomy patients.
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey S. Montgomery, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Strength Test and Exercise in people with Bladder Cancer, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess whether a pre-operative exercise training program (Prehabilitation) for elderly patients undergoing cystectomy for bladder cancer will lower their post-operative 90-day hospital readmission rate. (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.