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

Not Applicable

Completed

• Conditions: Invasive Breast Carcinoma; Breast Cancer
• Interventions: Other: Aerobic Exercise Intervention; Other: Quality-of-Life Assessment; Other: Resistance Exercise Intervention; Other: Questionnaire Administration

• Registration Number: NCT04667481
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-14
• Study Start: 2022-01-05
• Primary Completion: 2022-11-10
• Study Completion: 2022-11-10
• Results First Submitted: 2023-11-09
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Results First Posted: 2024-02-12
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group (digital exercise interventions)	Quality-of-Life Assessment	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.
Arm I (aerobic exercise)	Aerobic Exercise Intervention	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.
Arm I (aerobic exercise)	Resistance Exercise Intervention	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.
Arm II (resistance exercise)	Aerobic Exercise Intervention	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.
Arm II (resistance exercise)	Quality-of-Life Assessment	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.
Arm I (aerobic exercise)	Quality-of-Life Assessment	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.
Arm II (resistance exercise)	Questionnaire Administration	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.
Arm II (resistance exercise)	Resistance Exercise Intervention	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 (digital exercise interventions)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility	Week 24	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.

Secondary Outcome Measures

Name	Time	Method
Intervention Session Intensity	Up to 24 weeks	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.
Study Feasibility	Up to 24 weeks	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.
Intervention Acceptability	Up to 24 weeks	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.
Intervention Safety: Adverse Events	Up to 24 weeks	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.
Intervention Adherence	Up to 24 weeks	Participants will complete an RPE rating after each session. These ratings will be used to calculate adherence rate for each participant. A session with an RPE that is at or above the intended RPE will be considered adherent. The number of adherent sessions will be divided by the total number of sessions, whether the session was attended or not. The participant adherence rates will be averaged to find a mean adherence rate per participant.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States