NCT07746414

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Aug 2026Aug 2027

First Submitted

Initial submission to the registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

August 7, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 29, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

High-Intensity Interval Training (HIIT)

Outcome Measures

Primary Outcomes (1)

  • Mean concentration N-lactoyl phenylalanine

    Mean concentration N-lactoyl phenylalanine (pg/ml) in blood

    Pre-exercise (Baseline) and post-excercise (4 weeks)

Secondary Outcomes (5)

  • Mean score Memorial Anxiety Scale for Prostate Cancer (MAXPC)

    Pre-exercise (Baseline) and post-exercise (4 weeks)

  • Mean score Expanded Prostate Cancer Index Composite Short Form (EPIC-26)

    Pre-exercise (Baseline) and post-exercise (4 weeks)

  • Percentage of participants that used opioids

    Post operative (Day 1)

  • Percentage of participants readmitted

    Post operative (Day 1) up to 12 weeks

  • Mean number ER visits

    Post operative (Day 1) up to 12 weeks

Study Arms (1)

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.

Behavioral: High-intensity interval training (HIIT) exercise

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.

Radical prostatectomy + High-Intensity Interval Training (HIIT)

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Interventions

High-Intensity Interval TrainingExercise

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Michael Leapman, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Linsky, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 5, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

August 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified data will be shared at the PIs discretion.

Locations