N/A N=27 Randomized Single-blind Supportive Care

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

Breast Cancer · Invasive Breast Carcinoma

Bottom Line

View on ClinicalTrials.gov: NCT04667481 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Intervention Feasibility — 1; 3; 8; 6 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Aerobic Exercise Intervention (Other); Resistance Exercise Intervention (Other); Exercise Intervention: Digital copies and outline of sessions (Other); Questionnaire Administration (Other); Quality-of-Life Assessment (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Washington
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Intervention Feasibility	1; 3; 8; 6	—
SECONDARY Intervention Safety: Adverse Events	2; 3; 0; 0; 0; 0	—
SECONDARY Study Feasibility	2; 25	—
SECONDARY Intervention Acceptability	9; 9; 9; 9; 3; 4	—
SECONDARY Intervention Session Intensity	5.86; 5.60	—
SECONDARY Intervention Adherence	52.8; 40.7	—

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.

Eligibility Criteria

Inclusion Criteria

Age 18 - 75 years, inclusive
Female gender
Prior diagnosis of invasive breast cancer
Completion of chemotherapy or receipt of trastuzumab (Herceptin) therapy within the past 6 - 60 months (0.5 - 5 years)
Reduced cardiorespiratory functional capacity, defined as below the median estimated CRF for age/sex-matched controls

Exclusion Criteria

Actively receiving radiation treatment
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04667481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.