Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial
NCT ID: NCT04667481
Last Updated: 2024-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2022-01-05
2022-11-10
Brief Summary
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Detailed Description
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INTERVENTION GROUPS: Patients are randomized to 1 of 2 interventional arms.
ARM I: Patients participate in aerobic exercise (AE) sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and resistance exercise (RE) sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.
ARM II: Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.
CONTROL GROUP: After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm I (aerobic exercise)
Patients participate in AE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and RE sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.
Aerobic Exercise Intervention
Participate in aerobic exercise intervention
Resistance Exercise Intervention
Participate in resistance exercise intervention
Quality-of-Life Assessment
Ancillary studies
Arm II (resistance exercise)
Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.
Aerobic Exercise Intervention
Participate in aerobic exercise intervention
Resistance Exercise Intervention
Participate in resistance exercise intervention
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Control Group (digital exercise interventions)
After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.
Exercise Intervention: Digital copies and outline of sessions
Receive digital copy of AE and RE sessions and an outline of sessions
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Interventions
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Aerobic Exercise Intervention
Participate in aerobic exercise intervention
Resistance Exercise Intervention
Participate in resistance exercise intervention
Exercise Intervention: Digital copies and outline of sessions
Receive digital copy of AE and RE sessions and an outline of sessions
Questionnaire Administration
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Female gender
3. Prior diagnosis of invasive breast cancer
4. Completion of chemotherapy or receipt of trastuzumab (Herceptin) therapy within the past 6 - 60 months (0.5 - 5 years)
5. Reduced cardiorespiratory functional capacity, defined as below the median estimated CRF for age/sex-matched controls
Exclusion Criteria
2. Medical history of heart failure, coronary artery disease or arrhythmia
3. Contraindications to cardiopulmonary exercise testing (CPET)
4. 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
5. Contraindications to exercise, including a history of surgery with sequelae that restrict ability to exercise safely or comfortably
6. Unwilling to complete intervention procedures or outcome measures
18 Years
75 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Kerryn Reding
Associate Professor
Principal Investigators
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Kerryn W Reding, PhD, MPH, RN
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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10872
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2021-01114
Identifier Type: REGISTRY
Identifier Source: secondary_id
RG1121129
Identifier Type: -
Identifier Source: org_study_id
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