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

Impact Of Exercise Intensity On Cardiac Health In Young Adult Survivors Of Childhood Cancer: The PULSE Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Cardiotoxicity; Childhood Cancer Survivors; Anthracycline-induced Cardiotoxicity
• Intervention / Treatment: Behavioral: HIIT Exercise Program; Behavioral: MICT Exercise Program

Detailed Description

This phase 1, pilot, randomized clinical trial aims to evaluate the impact of exercise intensity on cardiac health in young adult survivors of childhood cancer previously treated with anthracyclines.

Participants will be randomized into 1 of 2 study groups: Arm 1: High-intensity interval training (HIIT) or Arm 2: moderate intensity continuous training (MICT).

The research study procedures include screening for eligibility, in-clinic visits, questionnaires, measurements of height, weight, waist, and hip circumference, blood pressure, cardiopulmonary fitness, activity measurements, blood tests, and electrocardiograms (ECGs).

Participation in this research study is expected to last about 4 months. It is expected that about 20 people will take part in this research study.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity Interval Training (HIIT); 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; Exercise program with stationary bike via the Zoom platform.
Active Comparator: Moderate Intensity Continuous Training (MICT); 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; Exercise program with stationary bike via the Zoom platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in resting blood pressure	Change in seated resting blood pressure (mmHg) measured after 5 minutes of quiet rest, using an automated cuff; measured 2-3 times with ≥30 seconds between readings (use mean of readings per protocol).	Baseline (Week 0) and post-intervention (Week 17)
Change in waist circumference	Change in waist circumference (cm) measured with a constant-tension tape at the level of the umbilicus.	Baseline (Week 0) and post-intervention (Week 17)
Change in hip circumference	Change in hip circumference (cm) measured with a constant-tension tape at the widest girth of the buttocks (greater trochanter landmark).	Baseline (Week 0) and post-intervention (Week 17)
Change in percent body fat (BIA)	Change in percent body fat (%) estimated by bioelectrical impedance analysis (BIA) using a validated device and standard testing procedures.	Baseline (Week 0) and post-intervention (Week 17)
Change in 30-second sit-to-stand repetitions	Change in number of completed sit-to-stand repetitions in 30 seconds from a standard chair stand test (arms crossed, standardized instructions).	Baseline (Week 0) and post-intervention (Week 17)
Change in 1-repetition maximum (1RM) leg press	Change in leg press 1RM load (maximum weight lifted once), assessed using a standardized warm-up and up to 5 attempts with rest intervals per protocol.	Baseline (Week 0) and post-intervention (Week 17)
Change in 1-repetition maximum (1RM) chest press	Change in chest press 1RM load (maximum weight lifted once), assessed using a standardized warm-up and up to 5 attempts with rest intervals per protocol.	Baseline (Week 0) and post-intervention (Week 17)
Change in Exercise Benefits/Barriers Scale (EBBS) total score	Change in EBBS total score from the 43-item Exercise Benefits/Barriers Scale questionnaire (higher/lower score interpreted per instrument scoring).	Baseline (Week 0) and post-intervention (Week 17)
Change in Quality-of-Life via EORTC QLQ-C30 Summary Score	Change in quality of life will be measured by the EORTC QLQ-C30 Summary Score, calculated from the EORTC QLQ-C30 questionnaire and scored per EORTC scoring manual. Reported as change from baseline to post-intervention.	Baseline (Week 0) and post-intervention (Week 17)
Change in Pittsburgh Sleep Quality Index Global Score	Change in sleep quality by using the Pittsburgh Sleep Quality Index (PSQI) Global Score, derived from the 19-item PSQI (sum of 7 component scores) and scored per PSQI scoring rules. Reported as change from baseline to post-intervention.	Baseline (Week 0) and post-intervention (Week 17)

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Christina Dieli-Conwright, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Estimated): March 4, 2027
• Study Completion (Estimated): March 4, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Heart Diseases; Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Cardiotoxicity
• Other Study ID Numbers: 25-691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No