Breast Cancer Clinical Trial

Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial

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.

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Full Description

OUTLINE: Patients are randomized to the interventional groups or control group.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years
Female gender
Prior diagnosis of invasive breast cancer
Receipt of chemotherapy or trastuzumab (Herceptin) therapy within the past 6 - 18 months
Reduced cardiorespiratory functional capacity, defined as < 80% of age/sex-matched six-minute walk distance (6MWD) (i.e. a 20% shorter distance)

Exclusion Criteria:

Currently exercising >150 min/week
Actively receiving chemotherapy or radiation
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

Study is for people with:

Breast Cancer

Estimated Enrollment:

27

Study ID:

NCT04667481

Recruitment Status:

Completed

Sponsor:

University of Washington

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There is 1 Location for this study

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Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

27

Study ID:

NCT04667481

Recruitment Status:

Completed

Sponsor:


University of Washington

How clear is this clinincal trial information?

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