Strive Cardio for Endometrial Cancer Survivors

The Effect of Combined Aerobic and Muscle Strengthening Exercises on Structural and Functional Cardiovascular Adaptations in Endometrial Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Endometrial Cancer
• Intervention / Treatment: Behavioral: 12-week home-based exercise intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Willing and able to provide written informed consent
• Willing to comply with study procedures and available for the duration of the study
• Fluent in spoken and written English
• Women 18 years of age or older
• Documented diagnosis of Type I, stage I-IIIc endometrial cancer within the past 5 years
• Completion of current cytotoxic treatment for endometrial cancer
• Technology access (phone call access, broadband internet, Wi-Fi) for tele coaching
• Comfort and willingness to use technology (videoconferencing) throughout the study for coaching
• Pass the Physical Activity Readiness Questionnaire (PAR-Q)
• Medical clearances given by their primary provider / oncologist (if indicated by the PAR-Q)

Exclusion Criteria

• Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic or musculoskeletal limitations)
• History of previous myocardial infarction, ischemia, or hemorrhagic stroke
• Medically documented history of heart disease including heart valve disease, coronary artery disease, heart failure, peripheral artery disease, aortic disease, pericardial disease, cerebrovascular disease, or deep vein thrombosis
• Medical documentation of treatment-resistant hypertension OR taking ≥2 medications to treat hypertension
• Medically documented history of cardiovascular disease including (but not limited to): bypass surgery, stent procedures, bypass grafts, or coronary angioplasty
• Medically documented or self-reported type 1 diabetes (insulin-dependents)
• Prescriptions for or use of semaglutide (GLP-1 agonists) including name brands: Ozempic, Wegovy or Mounjaro
• Current or recent (within last 3 months) use of hormone replacement therapy (HRT)
• Evidence of recurrent or metastatic disease
• Currently performing resistance training ≥2 days per week
• Currently exceeding 150 minutes of at least moderate intensity exercise per week
• Report of chest pain, shortness of breath, fainting, or angina pectoris
• Self-reported history of falling, fall risk
• Have physical disability that would limit range of motion through exercises such as sitting, standing and inability to walk one block
• Plans to move from the area
• Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to study enrollment
• Self-reported tobacco use in last 7 days, current smoking, current tobacco use including e-cigarettes and vaping devices
• Not suitable for study participation due to other reasons at the discretion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12-week 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.	Behavioral: 12-week home-based exercise intervention; All participants will be given the same 12-week distance-based exercise intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Vascular Stiffness Following Distance-Based Exercise Program	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.	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Vascular Function Following Distance-Based Exercise Program	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.	14 weeks
Changes in Atherosclerotic Cardiovascular Disease (ASCVD) Risk Profiles Following a Distance-Based Exercise Program	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.	14 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Functional Fitness	Within participant change of functional fitness from pre- to post-intervention as measured by the Functional Fitness Test.	14 weeks
Estimation of Muscle Strengthening Exercise Session Adherence	Proportion of planned exercise sessions in which a participant completes at least 50% of prescribed exercises.	14 weeks
Estimation of Adherence to Aerobic Physical Activity Guidelines (150 minutes/week)	Proportion of planned weeks a participant accumulates 150 minutes of moderate intensity activity per week.	14 weeks
Estimation of Tele-Coaching Adherence	Proportion of planned coaching sessions in which a participant completes.	14 weeks
Estimation of Intervention Acceptability	Within participant change of questionnaire scores from pre- to post-intervention. Likert scale ratings of quality of exercise equipment, educational materials, health coaching, study feedback and distance delivery format. Five point Likert scale ranging from extremely dissatisfied/ important to extremely satisfied/important. I higher score shows more satisfaction or feeling of importance with study measures.	14 weeks
Change in Waist to Hip ratio (WHR)	Within participant changes of waist and hip circumference, expressed as the ratio of waist circumference relative to hip circumference from pre- to post-intervention. A waist to hip ratio of over 0.85 in women is higher risk for negative health outcomes.	14 weeks
Changes in body weight	Within participant changes of body weight from pre- to post-intervention.	14 weeks
Changes in Ambulatory Activity Levels	Within participant change in average daily steps taken within a week from pre- to post-intervention as measured via ActiGraph accelerometer.	2 weeks
Changes in self-efficacy relating to aerobic exercise	Within participant change of questionnaire scores from pre- to post-intervention. This questionnaire includes ten questions each with a score from 0-9, the questionnaire is scored by multiplying each question response by ten and then summing those values for a total score. Questionnaire ranges from 0-90 with a higher score indicating higher confidence (higher self efficacy) in the participant's ability to complete aerobic exercise.	14 weeks
Changes in self-efficacy relating to strength exercises	Within participant change of questionnaire scores from pre- to post-intervention. This questionnaire includes ten questions each with a score from 0-9, the questionnaire is scored by multiplying each question response by ten and then summing those values for a total score. Questionnaire ranges from 0-90 with a higher score indicating higher confidence (higher self efficacy) in the participant's ability to complete strength exercises.	14 weeks
Changes in the Basic Psychological Needs in Exercise Scale	Within participant change of questionnaire score from pre- to post-intervention. Eleven questions on a five-point Likert score from "I don't agree at all" to "I completely agree." This questionnaire is scored from 11 to 55 with 55 showing the most satisfaction with exercise. There are three subscales which include: autonomy, competence, and relatedness.	14 weeks
Changes in the Exercise Regulations Questionnaire	Within participant change of questionnaire score from pre- to post-intervention. This questionnaire includes 24 questions scored on a five-point Likert scale from "Not true for me" to "Very true for me" that is scored according to standard protocols taking composite measures of higher Likert ratings. Questionnaire scores range from 0-124 with a higher number indicating a higher engagement and regulations towards exercise.	14 weeks
Changes in the Multidimensional Scale of Perceived Social Support	Within participant change of questionnaire score from pre- to post-intervention. This questionnaire includes 12questions on a seven-point Likert scale with the lowest being "Very strongly disagree" to Very strongly agree" that is scored according to standard protocols taking composite measures of higher Likert rating. Questionnaire scores range from 12-84 with the higher number indicating more social support.	14 weeks
Changes in the Food Frequency Questionnaire	Within participant change of questionnaire score from pre- to post-intervention. This questionnaire includes 16 questions on a nine-point Likert scale from "Never" to "4 or more times per day." This questionnaire relates to the amount of food consumed, and that results are scored via categories of fat, protein, and fruits and vegetables. Questionnaire scores range from 0 to 128, with a higher number indicating higher consumption of dietary components.	14 weeks

Collaborators and Investigators

• Sponsor: Jess S. Gorzelitz
• Investigators: Principal Investigator: Jess Gorzelitz, PHD, MS, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Actual): November 17, 2025
• Study Completion (Actual): November 17, 2025

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Telehealth; Arterial stiffness; Strength; Agility; Health Behaviors; Home-based; Flexibility; Aerobic Endurance; Functional Fitness; Muscle Strengthening
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Behavior; Cardiovascular Diseases; Endometrial Neoplasms; Motor Activity; Health Behavior
• Other Study ID Numbers: 202311588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No