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Not yet recruiting NCT07746414

Effects of Exercise Prior to Radical Prostatectomy

No phase Interventional Recovery Post Prostatectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-intensity interval training (HIIT) exercise.
Who it may be relevant to
Registry conditions: Recovery, Post Prostatectomy. Basic parameters: 35 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of High Intensity Interval Training Among Patients With Prostate Cancer Prior to Radical Prostatectomy

Overview

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

  • Behavioral High-intensity interval training (HIIT) exercise
    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.

Primary outcome measures

  • Mean concentration N-lactoyl phenylalanine [Time frame: Pre-exercise (Baseline) and post-excercise (4 weeks)]
Secondary outcome measures (5)
  • Mean score Memorial Anxiety Scale for Prostate Cancer (MAXPC) [Time frame: Pre-exercise (Baseline) and post-exercise (4 weeks)]
  • Mean score Expanded Prostate Cancer Index Composite Short Form (EPIC-26) [Time frame: Pre-exercise (Baseline) and post-exercise (4 weeks)]
  • Percentage of participants that used opioids [Time frame: Post operative (Day 1)]
  • Percentage of participants readmitted [Time frame: Post operative (Day 1) up to 12 weeks]
  • Mean number ER visits [Time frame: Post operative (Day 1) up to 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Yale New Haven Hospital — New Haven

Identifiers

NCT: NCT07746414 · 2000041449

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗