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This trial aims to evaluate the impact of exercise intensity on cardiac health in young adult survivors of childhood cancer previously treated with anthracyclines.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | Participants will be randomly assigned to the HIIT exercise group and receive:
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| Moderate Intensity Continuous Training (MICT) | Active Comparator | Participants will be randomly assigned to the MICT exercise group and receive:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIIT Exercise Program | Behavioral | Exercise program with stationary bike via the Zoom platform. |
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| 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) |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Dieli-Conwright | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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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| MICT Exercise Program | Behavioral | Exercise program with stationary bike via the Zoom platform. |
|
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) |
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) |
| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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