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Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial
NA trial testing Aerobic Exercise Intervention in Breast Cancer in 27 participants. Completed in 10 November 2022.
| Lead sponsor | University of Washington |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 27 |
| Start date | 5 January 2022 |
| Primary completion | 10 November 2022 |
| Estimated completion | 10 November 2022 |
| Sites | 1 location across United States |
University of Washington
Adults 18 to 75, female only, with Breast Cancer or Invasive Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm I: Aerobic Exercise | 1 | |
| Arm II: Resistance Exercise | 3 | |
| Arm I: Aerobic Exercise | 8 | |
| Arm II: Resistance Exercise | 6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 2 | |
| Arm II: Resistance Exercise | 3 | |
| Control Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 0 | |
| Arm II: Resistance Exercise | 0 | |
| Control Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 0 | |
| Arm II: Resistance Exercise | 1 | |
| Control Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 0 | |
| Arm II: Resistance Exercise | 0 | |
| Control Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 2 | |
| Arm II: Resistance Exercise | 3 | |
| Control Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 0 | |
| Arm II: Resistance Exercise | 0 | |
| Control Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 0 | |
| Arm II: Resistance Exercise | 0 | |
| Control Group | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 1 | |
| Arm II: Resistance Exercise | 2 | |
| Control Group | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| All Participants | 2 | |
| All Participants | 25 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 9 | |
| Arm II: Resistance Exercise | 9 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 9 | |
| Arm II: Resistance Exercise | 9 |
| Group | Value | 95% CI |
|---|---|---|
| Arm 1: Aerobic Exercise | 3 | |
| Arm II: Resistance Exercise | 4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Aerobic Exercise) | 5.86 | ± 1.37 |
| Arm II (Resistance Exercise) | 5.60 | ± 1.62 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Aerobic Exercise) | 52.8 | ± 31.0 |
| Arm II (Resistance Exercise) | 40.7 | ± 32.2 |
Time frame: Adverse events were collected every 2 weeks for all 24 weeks of the intervention.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm I: Aerobic Exercise | Arm II: Resistance Exercise | Control Group |
|---|---|---|---|---|
| Any Musculoskeletal | Musculoskeletal and connective tissue disorders | — | — | — |
| Any Neurological | Nervous system disorders | — | — | — |
| Any Gastrointestinal/Digestive | Gastrointestinal disorders | — | — | — |
| Injury | Musculoskeletal and connective tissue disorders | — | — | — |
| Any Respiratory | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Any Psychiatric | Psychiatric disorders | — | — | — |
| Any Skin | Skin and subcutaneous tissue disorders | — | — | — |
Data from ClinicalTrials.gov NCT04667481 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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