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

University of Washington27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Breast Cancer Invasive Breast Carcinoma

Interventions

Aerobic Exercise InterventionOTHER

Participate in aerobic exercise intervention

Resistance Exercise InterventionOTHER

Participate in resistance exercise intervention

Exercise Intervention: Digital copies and outline of sessionsOTHER

Receive digital copy of AE and RE sessions and an outline of sessions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 - 75 years, inclusive 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: 1. Actively receiving radiation treatment 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

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Outcomes

Primary Outcomes

Intervention Feasibility

Will be determined with all-cause intervention discontinuation rate, which is the proportion of all intervention participants who permanently stop the intervention prior to week 24 for any reason.

Time frame: Week 24

Secondary Outcomes

Intervention Safety: Adverse Events

Intervention safety will be determined by reviewing and quantifying the number of adverse events (mild, moderate, or severe), serious adverse events, and by reviewing the type and severity of adverse events attributed to study procedures among each study group.

Time frame: Up to 24 weeks

Study Feasibility

Study feasibility will be measured by calculating recruitment rates (proportion of enrolled participants to all individuals approached), and loss to follow-up (proportion of participants who do not complete post-intervention assessments). A benchmark to determine feasibility is \< 40% loss to follow-up.

Time frame: Up to 24 weeks

Intervention Acceptability

Acceptability will be measured with qualitative, open-ended to assess participant experience in the intervention and gather information for improving the protocol in future studies. Of particular attention will be the tolerability of a remote, home-based exercise intervention with a semi supervised format.

Time frame: Up to 24 weeks

Intervention Session Intensity

The Rating of Perceived Exertion (RPE) scale asks respondents to rate the intensity of exercise on a 1-10 scale, with higher values representing greater perceived exertion (1 = Very Light Activity, 10 = Maximum Possible Exertion). The measure has been validated for estimating both aerobic and resistance exercise exertion levels, providing a standard measure across intervention modalities. The average RPE for full-intensity sessions (the first few weeks involve an increasing RPE across sessions) will be calculated for each participant.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.