Strive Cardio for Endometrial Cancer Survivors
- Conditions
- Endometrial CancerCardiovascular Diseases
- Interventions
- Behavioral: 12-week home-based exercise intervention
- Registration Number
- NCT06534008
- Lead Sponsor
- Jess S. Gorzelitz
- Brief Summary
STRIVE Cardio is a 12-week exercise intervention study with the goal to improve functional fitness and cardiovascular health for women who have completed treatment for non-metastatic endometrial cancer within the last five years and are currently in remission. Measures will include a functional fitness test, carotid-femoral pulse wave velocity, brachial artery flow mediated dilation, and a blood draw. Participants will be provided resistance bands, a dumbbell, and a Fitbit to keep. Participants will be compensated $50 for each of their two in-person visits.
- Detailed Description
STRIVE Cardio is a distance-based exercise study for women who have completed treatment for non-metastatic endometrial cancer within the last five years and are currently in remission.
The intervention itself is 12 weeks of exercise, with one week of accelerometer wear prior to exercise with an additional week to schedule post-study visit procedures, yielding a total intervention length of 14 weeks. The exercise intervention will consist of (a) in-person pre-intervention study measures; (b) instructional materials (e.g. detailed exercise manual) and exercise training equipment (e.g. resistance bands, adjustable dumbbell, Fitbit Charge 5); (c) a virtually delivered instructional session; (d) access to informational web materials; (e) Support and feedback provided via virtual health coaching sessions; and (f) in-person post-intervention study measures.
Health coaching sessions will be delivered virtually and consist of (a) an initial health coaching session during week one discussing the participant's visions for health and wellness and overall goals of completing the intervention exercises; (b) sessions delivered once per week through week four discussing progress, barriers, facilitators, self-efficacy, and motivations for exercise goals to facilitate exercise adoption; (c) a midpoint check-in including a non-bias report from their health coach describing their progress thus far in the intervention. Participants then have the personal option to continue meeting with their health coach on a weekly basis or taper their health coaching sessions to include only weeks eight and eleven; (d) a final in person health coaching session to conclude.
The investigator's primary objective is to measure changes biomarkers of vascular structure and function following combined aerobic and muscle strengthening exercise in endometrial cancer survivors. The investigators hypothesize that there will be clinically meaningful improvements in structural and functional vascular biomarkers, and improved composite risk scores.
The investigator's two aims are to (1) Quantify the changes in vascular structure (pulse wave velocity) and function (flow mediated dilation) following a distance-based exercise program; and (2) Determine the magnitude of changes in ASCVD risk profiles following a distance-based exercise program.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 12-week Exercise Intervention 12-week home-based exercise intervention In this single-arm study, every participant will be enrolled in the 12-week distance-based exercise intervention. All participants will receive an exercise regimen and the necessary materials to complete and measure their exercise. All participants will receive weekly online heath coaching.
- Primary Outcome Measures
Name Time Method Changes in Vascular Stiffness Following Distance-Based Exercise Program 14 weeks Within participant change from pre- to post-intervention as measured by carotid-femoral pulse wave velocity, which is a measure of speed that is directly related to the stiffness of the arteries/vessels of the body.
- Secondary Outcome Measures
Name Time Method Changes in Vascular Function Following Distance-Based Exercise Program 14 weeks Within participant change from pre- to post-intervention as measured by brachial artery time to flow mediated dilation, which is a measure of endothelial cell function responding to constriction and dilation of the arteries/vessels of the body. A faster FMD measure indicates better endothelial cell function, which indicates better vascular function.
Changes in Atherosclerotic Cardiovascular Disease (ASCVD) Risk Profiles Following a Distance-Based Exercise Program 14 weeks Within participant change from pre- to post-intervention as measured by composite score expressed as a percentage from Atherosclerotic Cardiovascular Disease (ASCVD) Risk profile. ASCVD Risk score estimates the likelihood a person will develop atherosclerotic cardiovascular disease in the next 10 years. The higher the score, the more likely the person will have negative cardiovascular health outcomes. Less than 5% is considered a low score, and greater than 20% is considered a high score.
Trial Locations
- Locations (1)
University of Iowa
🇺🇸Iowa City, Iowa, United States