Childhood Cancer SurvivorsPULSENCT07442578
Impact of Exercise Intensity on Cardiac Health in Young Adult Survivors of Childhood Cancer: The PULSE Trial
A study testing HIIT Exercise Program and MICT Exercise Program in people with Childhood Cancer Survivors and Cardiotoxicity, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Childhood Cancer Survivors, Cardiotoxicity, Cardiovascular Diseases
- What is being tested?
- HIIT Exercise Program and MICT Exercise Program
- 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
- 4 Mar 2026to 4 Mar 2028
- 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 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Cancer Survivors, Cardiotoxicity, Cardiovascular Diseases, Anthracycline-induced Cardiotoxicity
- Being tested
- HIIT Exercise Program, MICT Exercise Program
- Medical subject headings
- Cardiotoxicity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT Exercise ProgramBehavioural
Exercise program with stationary bike via the Zoom platform.
MICT Exercise ProgramBehavioural
Exercise program with stationary bike via the Zoom platform.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: MICT Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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: %.
Measured: 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).
Measured: Baseline (Week 0) and post-intervention (Week 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start4 Mar 2026
- Primary completion4 Mar 2027 (estimated)
- Study completion4 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442578
- Sponsor's protocol ID
- 25-691
- Acronym
- PULSE
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Exercise Intensity On Cardiac Health In Young Adult Survivors Of Childhood Cancer: The PULSE Trial
- ClinicalTrials.gov ID
- NCT07442578
- Acronym / sponsor ID
- PULSE / 25-691
- Conditions
- Childhood Cancer Survivors, Cardiotoxicity, Cardiovascular Diseases, Anthracycline-induced Cardiotoxicity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 4 Mar 2027 (estimated)
- Study completion
- 4 Mar 2028 (estimated)
- First posted
- 2 Mar 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 trial aims to evaluate the impact of exercise intensity on cardiac health in young adult survivors of childhood cancer previously treated with anthracyclines.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | Behavioral: HIIT Exercise ProgramParticipants 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 |
| Moderate Intensity Continuous Training (MICT) | Active comparator | Behavioral: MICT Exercise ProgramParticipants 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 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| HIIT Exercise ProgramExercise program with stationary bike via the Zoom platform. | Behavioural | High Intensity Interval Training (HIIT) |
| MICT Exercise ProgramExercise program with stationary bike via the Zoom platform. | Behavioural | Moderate Intensity Continuous Training (MICT) |
Primary outcome
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.
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).
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).
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.
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.
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: %.
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).
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 18 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Christina Dieli-Conwright principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT Exercise Program and MICT Exercise Program in people with Childhood Cancer Survivors and Cardiotoxicity, run by Dana-Farber Cancer Institute 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 10 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average E/e' ratio (time frame: Baseline (Week 0) and post-intervention (Week 17)). The study lists 7 primary outcomes in all. 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 18 Mar 2026.