Breast CancerACTIVATENCT04667481
Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial
A study testing Aerobic Exercise Intervention, Resistance Exercise Intervention and Exercise Intervention: Digital copies and outline of sessions in people with Breast Cancer and Invasive Breast Carcinoma, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Invasive Breast Carcinoma
- What is being tested?
- Aerobic Exercise Intervention, Resistance Exercise Intervention and Exercise Intervention: Digital copies and outline of sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2022to 10 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Investigating Various Adaptive-Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment (ACTIVATE)
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.
Read the 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.
- Conditions
- Breast Cancer, Invasive Breast Carcinoma
- Being tested
- Aerobic Exercise Intervention, Resistance Exercise Intervention, Exercise Intervention: Digital copies and outline of sessions, Questionnaire Administration, Quality-of-Life Assessment
- Keywords
- breast cancer, exercise, fatigue, fitness, aerobic, survivor
- Medical subject headings
- Breast Neoplasms, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise InterventionOther
Participate in aerobic exercise intervention
Resistance Exercise InterventionOther
Participate in resistance exercise intervention
Exercise Intervention: Digital copies and outline of sessionsOther
Receive digital copy of AE and RE sessions and an outline of sessions
Questionnaire AdministrationOther
Ancillary studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (aerobic exercise) | Experimental | 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. Receives: Other: Aerobic Exercise Intervention; Other: Resistance Exercise Intervention; Other: Quality-of-Life Assessment |
| Arm II (resistance exercise) | Experimental | 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. Receives: Other: Aerobic Exercise Intervention; Other: Resistance Exercise Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment |
| Control Group (digital exercise interventions) | Experimental | 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. Receives: Other: Exercise Intervention: Digital copies and outline of sessions; Other: Questionnaire Administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
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.
Measured: Week 24
Secondary outcomes (5)
Intervention Safety: Adverse Events
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.
Measured: Up to 24 weeks
Study Feasibility
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.
Measured: Up to 24 weeks
Intervention Acceptability
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.
Measured: Up to 24 weeks
Intervention Session Intensity
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.
Measured: Up to 24 weeks
Intervention Adherence
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.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start5 Jan 2022
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kerryn Reding, University of Washington
- Investigators
- Kerryn W Reding, PhD, MPH, RN, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667481
- Sponsor's protocol ID
- RG1121129
- Other IDs
- P30CA015704, 10872, NCI-2021-01114
- Acronym
- ACTIVATE
- Status last verified
- Feb 2024
- First submitted
- 9 Nov 2020
- Last updated
- 12 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Various Adaptive-Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment (ACTIVATE)
- ClinicalTrials.gov ID
- NCT04667481
- Acronym / sponsor ID
- ACTIVATE / RG1121129
- Conditions
- Breast Cancer, Invasive Breast Carcinoma
- Keywords
- breast cancer, exercise, fatigue, fitness, aerobic, survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Posted 12 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (aerobic exercise) | Experimental | Other: Aerobic Exercise Intervention, Other: Resistance Exercise Intervention, Other: Quality-of-Life AssessmentPatients 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) | Experimental | Other: Aerobic Exercise Intervention, Other: Resistance Exercise Intervention, Other: Questionnaire Administration, Other: Quality-of-Life AssessmentPatients 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) | Experimental | Other: Exercise Intervention: Digital copies and outline of sessions, Other: Questionnaire Administration, Other: Quality-of-Life AssessmentAfter 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise InterventionParticipate in aerobic exercise intervention | Other | Arm I (aerobic exercise), Arm II (resistance exercise) |
| Resistance Exercise InterventionParticipate in resistance exercise intervention | Other | Arm I (aerobic exercise), Arm II (resistance exercise) |
| Exercise Intervention: Digital copies and outline of sessionsReceive digital copy of AE and RE sessions and an outline of sessions | Other | Control Group (digital exercise interventions) |
| Questionnaire AdministrationAncillary studies | Other | Arm II (resistance exercise), Control Group (digital exercise interventions) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (aerobic exercise), Arm II (resistance exercise), Control Group (digital exercise interventions) |
Primary outcome
Intervention Feasibility
Time frame: 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.
5 secondary outcomes
Intervention Safety: Adverse Events
Time frame: Up to 24 weeks
Study Feasibility
Time frame: Up to 24 weeks
Intervention Acceptability
Time frame: Up to 24 weeks
Intervention Session Intensity
Time frame: Up to 24 weeks
Intervention Adherence
Time frame: Up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerryn W Reding, PhD, MPH, RN principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Intervention, Resistance Exercise Intervention and Exercise Intervention: Digital copies and outline of sessions in people with Breast Cancer and Invasive Breast Carcinoma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.