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

University of Washington

Status: Completed

Conditions: Invasive Breast Carcinoma; Breast Cancer

Treatments: Other: Quality-of-Life Assessment; Other: Resistance Exercise Intervention; Other: Exercise Intervention: Digital copies and outline of sessions; Other: Aerobic Exercise Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04667481

RG1121129

NCI-2021-01114 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

10872

Details and patient eligibility

About

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.

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.

Enrollment: 27 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 3 patient groups

Arm I (aerobic exercise)

Experimental group

Description:

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.

Treatment:

Other: Aerobic Exercise Intervention

Other: Resistance Exercise Intervention

Other: Quality-of-Life Assessment

Arm II (resistance exercise)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Aerobic Exercise Intervention

Other: Resistance Exercise Intervention

Other: Quality-of-Life Assessment

Control Group (digital exercise interventions)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Exercise Intervention: Digital copies and outline of sessions

Other: Quality-of-Life Assessment