N/A
Completed N=27
Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial
Source: ClinicalTrials.gov NCT04667481 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Intervention Feasibility — 1; 3; 8; 6 Participants
Summary
This clinical trial studies the feasibility of implementing various adaptive training exercise programs to improve cardiorespiratory fitness in patients after receiving breast cancer treatment. Information from this study may help researchers better understand how to implement adaptive training interventions to improve cardiorespiratory fitness in patients after receiving breast cancer treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Feasibility |
1; 3; 8; 6 | — |
| SECONDARY Intervention Safety: Adverse Events |
2; 3; 0; 0; 0; 0 | — |
| SECONDARY Study Feasibility |
2; 25 | — |
| SECONDARY Intervention Acceptability |
9; 9; 9; 9; 3; 4 | — |
| SECONDARY Intervention Session Intensity |
5.86; 5.60 | — |
| SECONDARY Intervention Adherence |
52.8; 40.7 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 - 75 years, inclusive
- Female gender
- Prior diagnosis of invasive breast cancer
- Completion of chemotherapy or receipt of trastuzumab (Herceptin) therapy within the past 6 - 60 months (0.5 - 5 years)
- Reduced cardiorespiratory functional capacity, defined as below the median estimated CRF for age/sex-matched controls
Exclusion Criteria
- Actively receiving radiation treatment
- Medical history of heart failure, coronary artery disease or arrhythmia
- Contraindications to cardiopulmonary exercise testing (CPET)
- Contraindications to magnetic resonance imaging (MRI) (e.g ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices, non-compatible MRI tissue expanders or breast implants, or other implanted non-compatible MRI devices), weight over 550 lbs, or symptomatic claustrophobia
- Contraindications to exercise, including a history of surgery with sequelae that restrict ability to exercise safely or comfortably
- Unwilling to complete intervention procedures or outcome measures
Data sourced from ClinicalTrials.gov (NCT04667481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.