RecoveryNCT07746414
Effects of Exercise Prior to Radical Prostatectomy
A study testing High-intensity interval training (HIIT) exercise in people with Recovery and Post Prostatectomy, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Recovery, Post Prostatectomy
- What is being tested?
- High-intensity interval training (HIIT) exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: Effects of High Intensity Interval Training Among Patients With Prostate Cancer Prior to Radical Prostatectomy
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.
Read the detailed description
Participants will have a minimum of fourteen study visits.
- Conditions
- Recovery, Post Prostatectomy
- Being tested
- High-intensity interval training (HIIT) exercise
- Keywords
- High-Intensity Interval Training (HIIT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval training (HIIT) exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Radical prostatectomy + High-Intensity Interval Training (HIIT) | Experimental | Participants who undergo radical prostatectomy will perform HIIT exercise regimen for a minimum of four weeks prior to prostatectomy under the supervision of a physical therapist or exercise physiologist. Receives: Behavioral: High-intensity interval training (HIIT) exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean concentration N-lactoyl phenylalanine
Mean concentration N-lactoyl phenylalanine (pg/ml) in blood
Measured: Pre-exercise (Baseline) and post-excercise (4 weeks)
Secondary outcomes (5)
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.
Measured: Pre-exercise (Baseline) and post-exercise (4 weeks)
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.
Measured: Pre-exercise (Baseline) and post-exercise (4 weeks)
Percentage of participants that used opioids
Percentage of participants that used opioids post prostatectomy
Measured: Post operative (Day 1)
Percentage of participants readmitted
Percentage of participants readmitted to hospital post prostatectomy.
Measured: Post operative (Day 1) up to 12 weeks
Mean number ER visits
Mean number ER visits post prostatectomy
Measured: Post operative (Day 1) up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecoveryStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Leapman, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746414
- Sponsor's protocol ID
- 2000041449
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared at the PIs discretion.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Interval Training Among Patients With Prostate Cancer Prior to Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07746414
- Acronym / sponsor ID
- 2000041449
- Conditions
- Recovery, Post Prostatectomy
- Keywords
- High-Intensity Interval Training (HIIT)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical prostatectomy + High-Intensity Interval Training (HIIT) | Experimental | Behavioral: High-intensity interval training (HIIT) exerciseParticipants who undergo radical prostatectomy will perform HIIT exercise regimen for a minimum of four weeks prior to prostatectomy under the supervision of a physical therapist or exercise physiologist. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| High-intensity interval training (HIIT) exerciseThe intervention will consist of vigorous physical activity for a goal of 60 minutes each week for a minimum of four weeks prior to prostatectomy. | Behavioural | Radical prostatectomy + High-Intensity Interval Training (HIIT) |
Primary outcome
Mean concentration N-lactoyl phenylalanine
Time frame: Pre-exercise (Baseline) and post-excercise (4 weeks)
Mean concentration N-lactoyl phenylalanine (pg/ml) in blood
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared at the PIs discretion.
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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.
Michael Leapman, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training (HIIT) exercise in people with Recovery and Post Prostatectomy, run by Yale University 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 7 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Linsky, MPH (475-375-6129, sarah.linsky@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean concentration N-lactoyl phenylalanine (time frame: Pre-exercise (Baseline) and post-excercise (4 weeks)). 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 7 Aug 2026.