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NCT Number: NCT07442578

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Childhood Cancer Survivors Anthracycline-induced Cardiotoxicity Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIIT Exercise Program

Behavioral

Exercise program with stationary bike via the Zoom platform.

MICT Exercise Program

Behavioral

Exercise program with stationary bike via the Zoom platform.

Primary outcomes

  1. Change in average E/e' ratio

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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.

  2. Change in septal mitral annular e' velocity

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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).

  3. Change in lateral mitral annular e' velocity

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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).

  4. Change in left atrial maximum volume index (LAVImax)

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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.

  5. Change in peak tricuspid regurgitation velocity

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

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

  6. Change in left ventricular global longitudinal strain (LV GLS)

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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: %.

  7. Change in VO₂max

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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).

Other outcomes

  1. Change in resting blood pressure

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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).

  2. Change in waist circumference

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    Change in waist circumference (cm) measured with a constant-tension tape at the level of the umbilicus.

  3. Change in hip circumference

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    Change in hip circumference (cm) measured with a constant-tension tape at the widest girth of the buttocks (greater trochanter landmark).

  4. Change in percent body fat (BIA)

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    Change in percent body fat (%) estimated by bioelectrical impedance analysis (BIA) using a validated device and standard testing procedures.

  5. Change in 30-second sit-to-stand repetitions

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    Change in number of completed sit-to-stand repetitions in 30 seconds from a standard chair stand test (arms crossed, standardized instructions).

  6. Change in 1-repetition maximum (1RM) leg press

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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.

  7. Change in 1-repetition maximum (1RM) chest press

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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.

  8. Change in Exercise Benefits/Barriers Scale (EBBS) total score

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    Change in EBBS total score from the 43-item Exercise Benefits/Barriers Scale questionnaire (higher/lower score interpreted per instrument scoring).

  9. Change in Quality-of-Life via EORTC QLQ-C30 Summary Score

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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.

  10. Change in Pittsburgh Sleep Quality Index Global Score

    Time frame: Baseline (Week 0) and post-intervention (Week 17)

    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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Acronym: PULSE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 2, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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