Clinical trial · Interventional
Aerobic Exercise and Cognitive Functioning in Women With Breast Cancer
Aerobic Exercise and Cognitive Functioning in Women With Breast Cancer: the ACTIVATE Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In Canada, approximately 68 women are diagnosed with breast cancer every day. Chemotherapy-related cognitive changes (CRCC) are reported by up to 75% of breast cancer survivors during treatment and symptoms persist in 35% of survivors after treatment. Women report that CRCC negatively impacts their everyday functioning and substantially reduces their overall quality of life. Effective clinical interventions to manage CRCC are elusive. As a result, breast cancer survivors typically receive little to no advice on how to prevent or manage CRCC. Aerobic exercise is a type of physical activity that uses large muscle groups, is rhythmic in nature, and can be sustained for at least 10 minutes (e.g., walking, jogging, indoor cycling). It has been associated with improved quality of life in breast cancer survivors. It also holds great promise as an intervention to prevent or mitigate CRCC. However, there is limited evidence from experimental studies to confirm this. Therefore, the primary aim of this trial is to evaluate the impact of a supervised aerobic exercise intervention on CRCC in women diagnosed with early-stage breast cancer. Recruited women will be randomized into one of two groups: (1) aerobic exercise during chemotherapy, or (2) usual care during chemotherapy and the aerobic exercise post-chemotherapy (i.e., wait-list control group). This study will test several novel hypotheses, including whether exercise during chemotherapy can prevent and/or mitigate CRCC and its negative impact on quality of life among women with breast cancer, and whether the timing of the exercise intervention matters (i.e., exercise during versus after chemotherapy). The results of this study aim to address the concerns of women affected by CRCC who are currently lacking available evidence-based treatment options, as well as oncology care providers' need to have options to recommend to their patients to prevent or manage CRCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic Exercise | Behavioral | — | UNRESOLVED |
| Usual Care (Wait-list Control) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aerobic Exercise
- description
- Participants will complete three supervised aerobic exercise sessions each week using the treadmill, stationary bicycle or elliptical training for the duration of their chemotherapy (12-18 weeks). Aerobic exercise will be performed for 20-40 minutes at 50-75% of heart rate reserve. Participants will wear heart rate monitors during all supervised sessions (Polar Electro Inc., Lake Success, NY) and will be provided with target heart rates that will be individualized using their baseline (i.e., week 0) assessment data. Home-based exercise will be introduced in week 3. For the home-based sessions, participants will be asked to complete at least 1 session per week of 30 minutes of aerobic exercise (an activity of their choosing; e.g., walking).
- interventionNames
- Behavioral: Aerobic Exercise
- type
- OTHER
- label
- Usual Care (Wait-list Control)
- description
- Participants randomly assigned to UC group will be advised to continue with their regular activities of daily living. Following their chemotherapy, the UC group will receive the exercise intervention (lasting 12 weeks).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with stage I-III breast cancer; * Scheduled to receive adjuvant or neoadjuvant chemotherapy; * Able to speak and understand English in order to complete the study outcome measures; * Approval of medical oncologist to participate in the exercise intervention Exclusion Criteria: * Having previously received chemotherapy or radiation therapy; * Score \<24 at baseline on the Montreal Cognitive Assessment (MoCA; indicating moderate to severe cognitive impairment); * Having received a diagnosis of severe anxiety or mood disorder within the past year; * Having a medical condition that could impact cognition (e.g., prior head injury, substance use disorder); * Currently meeting American College of Sports Medicine (ACSM) aerobic exercise guidelines for cancer survivors in the 3 months prior to enrolment; * Body mass index ≥45 kg/m2; * Mobility issues that require a mobility aid or that prevent exercise on a bike, treadmill, or elliptical (e.g., orthopedic injury, severe arthritis). Additional Inclusion/Exclusion Criteria: During the screening process, patients will be informed that they can participate in additional optional assessments (i.e., MRI and EEG (Vancouver site only for EEG) Additional inclusion criteria for MRI: * Right-handedness, because language is lateralized and has been shown to be left side dominant (for right handers) during MRI tasks; * Able to read, understand, and provide informed consent in English for the additional assessments. Additional exclusion criteria for MRI are: * Metal implants (e.g., pacemaker) or metal dental work (aside from fillings) that would preclude scanning; * Claustrophobia; * Poor eyesight (not correctable with contact lenses) that precludes viewing stimuli presented in the scanner; * Lower back pain that would preclude a person from lying relatively still for one hour; * Breast tissue expander(s) inserted in the surgery site.
References
Publications (2)
- DERIVEDDamji S, Sattari S, Zadravec K, Campbell KL, Brunet J, Virji-Babul N. Changes in EEG Microstate Dynamics and Cognition Post-Chemotherapy in People With Breast Cancer. Brain Behav. 2025 Mar;15(3):e70335. doi: 10.1002/brb3.70335. PMID 40038798
- DERIVEDBrunet J, Barrett-Bernstein M, Zadravec K, Taljaard M, LeVasseur N, Srikanthan A, Bland KA, Collins B, Kam JWY, Handy TC, Hayden S, Simmons C, Smith AM, Virji-Babul N, Campbell KL. Study protocol of the Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial: a two-arm, two-centre randomized controlled trial. BMC Cancer. 2020 Jul 31;20(1):711. doi: 10.1186/s12885-020-07196-3. PMID 32736542