Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy (WISER-NET)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03280836|
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : December 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Physical Activity||Behavioral: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomized to the intervention or control arm.|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Women In Steady Exercise Research - Neoadjuvant Exercise Trial|
|Actual Study Start Date :||August 3, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
No Intervention: Control
We ask that participants in the control arm do not start an exercise program.
Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.
Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.
- Acceptability: Percent of eligible patients that provide consent and are enrolled in the study. [ Time Frame: 1 year ]Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.
- Feasibility of the study will be assessed by documenting participant adherence to the exercise intervention. [ Time Frame: 18 months ]Heart monitors will be used to quantify adherence.
- Efficacy of the intervention will be assessed by determining the change in cardiopulmonary fitness level between control and experimental group using cardiopulmonary exercise test [ Time Frame: 18 months ]Participants will complete a baseline and follow up cardiopulmonary exercise test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280836
|Contact: Kathleen M Sturgeon, PhD||717-531-0003 ext firstname.lastname@example.org|
|Contact: Kathryn H Schmitz, PhDemail@example.com|
|United States, Pennsylvania|
|Penn State Hershey Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Kathleen M Sturgeon, PhD 717-531-0003 ext 284676 firstname.lastname@example.org|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Laney Smith 215-615-3245 Amanda.Smith4@uphs.upenn.edu|
|Principal Investigator:||Kathleen M Sturgeon, PhD||Assistant Professor, Penn State|