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

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    30
  • sponsor
    University of Washington
Updated on 13 March 2022
trastuzumab
herceptin
invasive breast cancer

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.

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.

Details
Condition Breast Cancer, Invasive Breast Carcinoma
Treatment questionnaire administration, quality-of-life assessment, Aerobic Exercise Intervention, Resistance Exercise Intervention, Exercise Intervention: Digital copies and outline of sessions
Clinical Study IdentifierNCT04667481
SponsorUniversity of Washington
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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