Effects of Exercise Prior to Radical Prostatectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-80
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
High-intensity interval training (HIIT) exercise
BehavioralThe intervention will consist of vigorous physical activity for a goal of 60 minutes each week for a minimum of four weeks prior to prostatectomy.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Radical prostatectomy + High-Intensity Interval Training (HIIT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean concentration N-lactoyl phenylalanine
Mean concentration N-lactoyl phenylalanine (pg/ml) in blood
Time frame
Pre-exercise (Baseline) and post-excercise (4 weeks)Secondary outcomes
1
Mean score Memorial Anxiety Scale for Prostate Cancer (MAXPC)
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.
Time frame
Pre-exercise (Baseline) and post-exercise (4 weeks)2
Mean score Expanded Prostate Cancer Index Composite Short Form (EPIC-26)
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.
Time frame
Pre-exercise (Baseline) and post-exercise (4 weeks)3
Percentage of participants that used opioids
Percentage of participants that used opioids post prostatectomy
Time frame
Post operative (Day 1)4
Percentage of participants readmitted
Percentage of participants readmitted to hospital post prostatectomy.
Time frame
Post operative (Day 1) up to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: