Impact of Exercise Intensity on Cardiac Health in Young Adult Survivors of Childhood Cancer: The PULSE Trial

NCT07442578 | Active Not Recruiting DMC

• 1 other identifier: 25-691
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aims to evaluate the impact of exercise intensity on cardiac health in young adult survivors of childhood cancer previously treated with anthracyclines.

Conditions

Childhood Cancer Survivors; Cardiotoxicity; Cardiovascular Diseases; Anthracycline-induced Cardiotoxicity

Outcome Measures

Primary Outcomes (7)

• Change in average E/e' ratio

  Average E/e' ratio assessed by echocardiography using Doppler methods per ASE/EACVI guidance. E is the early diastolic transmitral inflow velocity (pulsed-wave Doppler) and e' is early diastolic mitral annular tissue velocity (tissue Doppler); average e' is typically the mean of septal and lateral e'. Reported as change from baseline to post-intervention.

  Baseline (Week 0) and post-intervention (Week 17)

• Change in septal mitral annular e' velocity

  Septal e' velocity measured by tissue Doppler imaging at the septal mitral annulus. Reported as change from baseline to post-intervention. Units: cm/s (or m/s).

  Baseline (Week 0) and post-intervention (Week 17)

• Change in lateral mitral annular e' velocity

  Lateral e' velocity measured by tissue Doppler imaging at the lateral mitral annulus. Reported as change from baseline to post-intervention. Units: cm/s (or m/s).

  Baseline (Week 0) and post-intervention (Week 17)

• Change in left atrial maximum volume index (LAVImax)

  Maximum left atrial volume indexed to body surface area (mL/m²) measured by 2D echocardiography (e.g., biplane method of disks). Reported as change from baseline to post-intervention.

  Baseline (Week 0) and post-intervention (Week 17)

• Change in peak tricuspid regurgitation velocity

  Peak tricuspid regurgitation (TR) jet velocity measured by continuous-wave Doppler. Reported as change from baseline to post-intervention. Units: m/s.

  Baseline (Week 0) and post-intervention (Week 17)

• Change in left ventricular global longitudinal strain (LV GLS)

  LV global longitudinal strain measured by 2D speckle-tracking echocardiography (typically averaged across LV segments from apical views). Reported as change from baseline to post-intervention. Units: %.

  Baseline (Week 0) and post-intervention (Week 17)

• Change in VO₂max

  Change in peak oxygen uptake (VO₂max) during a graded cycle cardiopulmonary exercise test (CPET), reported as VO₂max (mL/kg/min), derived from expired gas analysis (averaging interval per prespecified CPET analysis approach).

  Baseline (Week 0) and post-intervention (Week 17)

Other Outcomes (10)

• Change in resting blood pressure

  Baseline (Week 0) and post-intervention (Week 17)

• Change in waist circumference

  Baseline (Week 0) and post-intervention (Week 17)

• Change in hip circumference

  Baseline (Week 0) and post-intervention (Week 17)

Study Arms (2)

High Intensity Interval Training (HIIT)

EXPERIMENTAL

Participants will be randomly assigned to the HIIT exercise group and receive: * Baseline visit and surveys * 3x weekly for 16 week home-based virtually supervised High-Intensity Interval Training * Post-intervention visit and surveys

Behavioral: HIIT Exercise Program

Moderate Intensity Continuous Training (MICT)

ACTIVE COMPARATOR

Participants will be randomly assigned to the MICT exercise group and receive: * Baseline visit and surveys * 3x weekly for 16 week home-based virtually supervised Moderate Intensity Continuous Training * Post-intervention visit and surveys

Behavioral: MICT Exercise Program

Interventions

HIIT Exercise Program BEHAVIORAL

Exercise program with stationary bike via the Zoom platform.

High Intensity Interval Training (HIIT)

MICT Exercise Program BEHAVIORAL

Exercise program with stationary bike via the Zoom platform.

Moderate Intensity Continuous Training (MICT)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Current age at study initiation 18-39 years.
• Cancer diagnosis at age ≤ 18 years.
• Previous exposure to any dose of anthracyclines.
• Are ≥2 years post-treatment and in remission without relapse after cancer directed therapy.
• Eastern Cooperative Oncology Group Performance Status = 0
• Oncology survivorship provider clearance to participate in exercise
• No self-reported comorbidities or contraindications that prohibit the undertaking of high intensity exercise (e.g., severe valvular heart disease)
• Sedentary (i.e., currently participates in ≤ 60 minutes of structured high or moderate intensity exercise/week) determined by self-report during screening using the Godin Leisure Time Exercise Questionnaire
• Speak English
• Willing to travel to Dana-Farber Cancer Institute for necessary data collection

You may not qualify if:

• Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise.
• Patients who are pregnant.
• Participate in more than 60 minutes of structured moderate-to-vigorous exercise per week over the last month.
• Patients receiving treatment for other active malignancies (except basal cell carcinoma).
• Subjects who in the opinion of the investigators, may not be able to comply with the safety monitoring requirements of the study.
• Unable to travel to DFCI Longwood campus for necessary data collection.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Cardiotoxicity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Christina Dieli-Conwright

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 2, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): March 4, 2027
• Study Completion (Estimated): March 4, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)