Clinical trial · Interventional
High-intensity Exercise After Treatment
Enhancing Cognitive and Cardiovascular Function in Breast Cancer Survivors Through High-intensity Interval Training
NCT04950010CI-TRIAL-00080471HEATterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Original PI moved to a new institution
Summary
Brief summary (as posted)
This pilot study tests the feasibility and preliminary efficacy of an 8-week, 3-arm pilot exercise trial in which 45 breast cancer survivors will be randomized to high-intensity interval training (HIIT; n=15), moderate-intensity aerobic training (MOD; n=15), or Usual Care (UC; n=15).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Intensity Interval Training | Behavioral | — | UNRESOLVED |
| Moderate-Intensity Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- High-Intensity Interval Training (HIIT)
- description
- Breast cancer survivors randomized to HIIT will participate in a high-intensity interval training program for 8 weeks.
- interventionNames
- Behavioral: High-Intensity Interval Training
- type
- ACTIVE_COMPARATOR
- label
- Moderate-Intensity Exercise (MOD)
- description
- Breast cancer survivors randomized to MOD will participate in a moderate-intensity aerobic exercise program for 8 weeks.
- interventionNames
- Behavioral: Moderate-Intensity Exercise
- type
- NO_INTERVENTION
- label
- Usual Care (UC)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Adult female (aged 19 or older) * First, primary diagnosis of Stage I-IIIa breast cancer * Hormone receptor positive (ER+ and/or PR+) diagnosis * Human epidermal growth factor receptor 2 negative (HER2-) diagnosis * Completed primary adjuvant treatment (i.e., surgery, chemotherapy, and/or radiation therapy) * Currently prescribed an aromatase inhibitor * No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive Status (TICS-M; score \>21) * Sedentary except for casual lifestyle recreation. This is defined as self-reporting 20+ minutes of exercise physical activity on 2 or fewer days per week within the previous six months. * Receive physician's clearance to participate in an exercise program * Agree to be randomized * Fully vaccinated for COVID-19 ≥2 weeks prior to participation * Provide written informed consent to participate in study Exclusion Criteria: * Males. * Stage 0 breast cancer diagnosis or metastatic disease * Currently receiving chemotherapy or radiation therapy for any cancer * Scheduled to receive breast surgery (e.g., mastectomy, reconstructive surgery) during the study period * Second cancer diagnosis (excluding non-invasive skin cancers; including breast cancer recurrence) * Self-report an 20+ minutes of exercise physical activity on 3+ days per week for the previous 6 months * Pregnant or plan to become pregnant during study period. * Is not cleared to participate in exercise by a physician. * Enrolled in another physical activity program * Unable to cycle on a stationary bike * Unwilling to complete study requirements * History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal * Clinically significant TICS-M score (\<21) during baseline procedures * Not fully vaccinated for COVID-19
References
Publications (0)
Data not yet available
No reference posted for this study.