Clinical trial NCT04667481: Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial
Official title: Investigating Various Adaptive-Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment (ACTIVATE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Invasive Breast Carcinoma
Keywords: breast cancer
exercise
fatigue
fitness
aerobic
survivor
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-12-14
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention Feasibility
timeFrame: Week 24
Secondary outcomes:
measure: Intervention Safety: Adverse Events
timeFrame: Up to 24 weeks
measure: Study Feasibility
timeFrame: Up to 24 weeks
measure: Intervention Acceptability
timeFrame: Up to 24 weeks
measure: Intervention Session Intensity
timeFrame: Up to 24 weeks
measure: Intervention Adherence
timeFrame: Up to 24 weeks
Other outcomes:
measure: Maximal Exercise Capacity (Absolute)
timeFrame: Up to 24 weeks
measure: Maximal Exercise Capacity (Relative to Bodyweight)
timeFrame: Up to 24 weeks
measure: Submaximal Exercise Capacity
timeFrame: Up to 24 weeks
measure: Anthropometrics (Weight)
timeFrame: Up to 24 weeks
measure: Anthropometrics (Hip Circumference)
timeFrame: Up to 24 weeks
measure: Anthropometrics (Height)
timeFrame: Up to 24 weeks
measure: Abdominal Deposits of Fat
timeFrame: Up to 24 weeks
measure: Intermuscular Fat (IMF)
timeFrame: Up to 24 weeks
measure: Anthropometrics (Waist Circumference)
timeFrame: Up to 24 weeks
measure: Change in Quality of Life
timeFrame: Up to 24 weeks
measure: Physical Activity and Sedentary Behaviors (IPAQ)
timeFrame: Up to 24 weeks
measure: Perceived Well-being
timeFrame: Up to 24 weeks
measure: Physical Activity and Sedentary Behaviors (SBQ)
timeFrame: Up to 24 weeks
measure: Level of Fatigue
timeFrame: Up to 24 weeks
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: University of Washington
name: Kerryn W Reding, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References: