Exercise and Physical Activity Programs for Prostate Cancer Recovery

(CONTROL4LIFE Trial)

Overseen By Chris Sellar

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Urinary incontinence drugs

Disqualifiers: Neurological diseases, Exercise contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how exercise and physical activity affect recovery after prostate cancer surgery. Researchers are examining how these programs improve continence (bladder control), sexual function, and overall health. Participants will either follow a pelvic floor and general exercise program or receive standard care with physical activity counseling. This trial is ideal for those diagnosed with prostate cancer who are scheduled for surgery and can engage in mild physical activity.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance recovery strategies for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have recently changed medications for urinary incontinence, you may not be eligible to participate.

What prior data suggests that these exercise and physical activity programs are safe for prostate cancer recovery?

Research has shown that both pelvic floor exercises and general exercise are safe for individuals recovering from prostate cancer surgery. Pelvic floor exercises, such as Kegels, can help with issues like urinary leakage after surgery. These exercises not only improve bladder control but might also enhance sexual performance.

General exercise is also safe and beneficial. Studies have found that exercise can reduce cancer severity and aid recovery. It has been particularly beneficial for men with prostate cancer, even during treatment. Overall, both types of exercise programs in this study are safe and can improve quality of life after prostate surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise programs for prostate cancer recovery because they combine pelvic floor exercises with general physical activity, which is not typically emphasized in standard care. These programs aim to enhance recovery by improving overall physical fitness and specifically targeting pelvic floor strength, which can help with issues like incontinence that many prostate cancer patients face. Additionally, the inclusion of personalized physical activity counseling ensures that the exercise regimen is tailored to each individual's needs, potentially leading to better adherence and outcomes compared to generic exercise advice.

What evidence suggests that this trial's treatments could be effective for prostate cancer recovery?

Research has shown that pelvic floor muscle exercises, which participants in this trial may receive, can significantly improve urinary incontinence after prostate surgery, enhancing it by up to 2.77 times. These exercises might also aid in improving erectile function. General exercise, another component of the intervention arm in this trial, offers benefits such as reducing cancer severity and enhancing the quality of life for those with prostate cancer. It can also improve erectile function compared to usual care. While no clear benefits exist for slowing disease progression or improving heart health, exercise remains a promising method to boost recovery after prostate surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Nathan Hoy, MD

Principal Investigator

University of Alberta

Howard Evans, MD

Principal Investigator

University of Alberta

Margaret McNeely

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

Men who speak English, have prostate cancer (stages I-IV), and are set for prostatectomy surgery can join. They must be able to do mild exercise as confirmed by a questionnaire, be 18 or older, and willing to commit to a 12-week intervention if choosing the optional exercise component. Men with conditions affecting continence or contraindications to exercise, recent changes in incontinence meds, or no internet/smart device access cannot participate.

Inclusion Criteria

I am scheduled for surgery to remove my prostate.

I have been diagnosed with prostate cancer at any stage.

I am willing and able to commit to a 12-week exercise program.

Exclusion Criteria

Have any contraindications to exercise testing or training

I do not have conditions like neurological diseases affecting my bladder control.

I haven't changed my incontinence medication in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a combined pelvic health rehabilitation and exercise program delivered both in-person and virtually

12 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for recovery of continence, sexual function, and health outcomes after treatment

One year

What Are the Treatments Tested in This Trial?

Interventions

• General exercise
• Pelvic floor exercise program
• Physical Activity Counseling

Trial Overview

The CONTROL 4 LIFE study is testing how general exercises and physical activity counseling along with pelvic floor exercises affect recovery of continence, sexual function, fitness and overall health after prostate cancer surgery. Participants will also receive Alberta Health Services resources on pre- and post-surgery care.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

Pelvic floor exercise program and general exercise programming

Group II: Control Active Control 2 Interventions

Pelvic floor exercises and standard care (physical activity counseling)

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

In a randomized controlled trial involving 60 patients, pelvic floor muscle exercises (PFME/Kegel) significantly reduced post-surgery incontinence problems after robot-assisted radical prostatectomy, with notable improvements observed at 3 and 6 months.

The study demonstrated that PFME is an effective intervention for enhancing quality of life in patients suffering from incontinence following prostate surgery, indicating its suitability as a rehabilitation strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Pelvic Floor Muscle Training On Incontinence Problems After Radical Prostatectomy. Aydın Sayılan, A., Özbaş, A.[2019]

In a study of 60 prostate cancer patients undergoing radiotherapy, those who performed Kegel exercises showed a lower incidence of urinary incontinence compared to the control group, with only 3.3% developing 2nd-grade urinary incontinence by the end of the 8th week versus 10% in the control group.

Kegel exercises not only helped prevent urinary incontinence but also significantly improved quality of life measures, including social function and global health status, while reducing fatigue and gastrointestinal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Kegel exercises on the prevention of urinary and fecal incontinence in patients with prostate cancer undergoing radiotherapy. Urvaylıoğlu, AE., Kutlutürkan, S., Kılıç, D.[2021]

Men who underwent pelvic muscle exercise (PME) with biofeedback after radical prostatectomy regained urinary continence faster (mean of 51 days) compared to those who did not receive PME instruction (56 days).

While the PME/biofeedback group showed improvements in urinary incontinence metrics such as episodes and pad usage, these changes were not statistically significant, indicating that further research is needed to confirm the effectiveness of PME as a treatment for urinary incontinence post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic muscle exercise/biofeedback for urinary incontinence after prostatectomy: an education program. Mathewson-Chapman, M.[2015]

An individualized pelvic physical therapy program for 136 men with post-prostatectomy urinary incontinence significantly reduced daily pad usage and pelvic pain, indicating its efficacy in treating stress urinary incontinence (SUI).

The study found that many patients had both overactive and underactive pelvic floor dysfunction, and the tailored approach, which included relaxation training and strengthening, was more effective than traditional Kegel exercises alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized pelvic physical therapy for the treatment of post-prostatectomy stress urinary incontinence and pelvic pain. Scott, KM., Gosai, E., Bradley, MH., et al.[2021]

Pelvic floor muscle exercises (PFME) significantly improve urinary continence in patients recovering from prostate surgery, with an odds ratio of 2.971 indicating a higher likelihood of achieving continence compared to those who do not perform PFME.

The study suggests that adding assistant interventions to PFME further enhances recovery, with an odds ratio of 2.128, but emphasizes the need for more high-quality research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Pelvic Floor Exercise for Post-prostatectomy Incontinence: Systematic Review and Meta-analysis. Park, JJ., Kwon, A., Park, JY., et al.[2022]

Supervised pelvic floor muscle exercises (PFME) significantly improve urinary incontinence remission rates in men after prostate surgery, especially within the first 6 months, with risk differences of 12 to 25% compared to no exercise.

Unsupervised PFME does not provide the same benefits as supervised training and is similar to no exercise at all, highlighting the importance of structured rehabilitation programs for effective recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised pelvic floor muscle exercise is more effective than unsupervised pelvic floor muscle exercise at improving urinary incontinence in prostate cancer patients following radical prostatectomy - a systematic review and meta-analysis. Baumann, FT., Reimer, N., Gockeln, T., et al.[2022]

A systematic review of exercise trials in prostate cancer survivors found that while 93% of studies applied the principle of specificity in exercise programming, other key principles like progression and overload were less frequently applied, indicating potential inadequacies in exercise stimulus.

Although 79% of studies reported the components of the exercise prescription, none fully reported participant adherence to the prescribed programs, highlighting a gap that could hinder understanding the optimal exercise dose for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention to the principles of exercise training in exercise studies on prostate cancer survivors: a systematic review. Neil-Sztramko, SE., Medysky, ME., Campbell, KL., et al.[2020]

In a study of 175 couples, prostate cancer patients' self-efficacy was found to enhance the support they received from their partners, which in turn led to increased engagement in pelvic floor exercises (PFE) after surgery.

While partner support positively influenced patients' self-efficacy, the evidence for support as a predictor of self-efficacy was less consistent, suggesting a complex relationship between these factors in managing post-surgery incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enabling or Cultivating? The Role of Prostate Cancer Patients' Received Partner Support and Self-Efficacy in the Maintenance of Pelvic Floor Exercise Following Tumor Surgery. Hohl, DH., Knoll, N., Wiedemann, A., et al.[2018]

Intensive physiotherapist-guided pelvic floor muscle exercises (PG-PFME) did not show a significant benefit over standard information folder-guided pelvic floor muscle exercises (F-PFME) in helping men regain urinary continence after retropubic radical prostatectomy, with similar recovery rates at 6 months (30% vs. 27%).

The study identified that the amount of urine loss one week after catheter removal may be an important predictor of whether a patient will regain continence, highlighting the need for further research to confirm these findings and explore new treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The recovery of urinary continence after radical retropubic prostatectomy: a randomized trial comparing the effect of physiotherapist-guided pelvic floor muscle exercises with guidance by an instruction folder only. Dubbelman, Y., Groen, J., Wildhagen, M., et al.[2010]

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