Post Prostatectomy, Recovery
Conditions
Keywords
High-Intensity Interval Training (HIIT)
Brief summary
This pilot study will explore the metabolic and psychological effects of High-Intensity Interval Training (HIIT) exercise as well as its impact on patient recovery from radical prostatectomy.
Detailed description
Participants will have a minimum of fourteen study visits.
Interventions
The intervention will consist of vigorous physical activity for a goal of 60 minutes each week for a minimum of four weeks prior to prostatectomy.
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled or intended treatment with radical prostatectomy at Yale New Haven Hospital * English language fluency * Clinically localized low, intermediate or high risk by National Comprehensive Cancer Network (NCCN) criteria * Able to attend 2 in person exercise training sessions per week for four-six weeks
Exclusion criteria
* Treatment with non-surgical modality * Prior therapy for prostate cancer (e.g. radiation therapy or focal therapy) * Already engaged in regular exercise (\>60 minutes per week) * Unstable cardiovascular disease * Physical mobility limitation, unable to walk or exercise * Locally advanced (cT4 or cN1 or cM1) prostate cancer * Prior treatment with androgen deprivation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean concentration N-lactoyl phenylalanine | Pre-exercise (Baseline) and post-excercise (4 weeks) | Mean concentration N-lactoyl phenylalanine (pg/ml) in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean score Memorial Anxiety Scale for Prostate Cancer (MAXPC) | Pre-exercise (Baseline) and post-exercise (4 weeks) | Questionnaire specifically designed to identify and measure cancer-related anxiety in men diagnosed with prostate cancer. Total score range is 0 to 54, with a higher score indicating a greater level of anxiety. |
| Mean score Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | Pre-exercise (Baseline) and post-exercise (4 weeks) | A comprehensive instrument designed to evaluate patient function and bother after prostate cancer on five health-related quality of life domains each scored on a scale of 0 to 100. Higher scores indicate better function and fewer symptoms or lower treatment bother. |
| Percentage of participants that used opioids | Post operative (Day 1) | Percentage of participants that used opioids post prostatectomy |
| Percentage of participants readmitted | Post operative (Day 1) up to 12 weeks | Percentage of participants readmitted to hospital post prostatectomy. |
| Mean number ER visits | Post operative (Day 1) up to 12 weeks | Mean number ER visits post prostatectomy |
Countries
United States
Contacts
CONTACTSarah Linsky, MPH
PRINCIPAL_INVESTIGATORMichael Leapman, MD
Yale University
Outcome results
None listed