Strive Cardio for Endometrial Cancer Survivors

NCT06534008 | Completed

• 1 other identifier: 202311588
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer; Cardiovascular Diseases

Keywords

Functional Fitness; Arterial stiffness; Health Behaviors; Home-based; Exercise; Muscle Strengthening; Aerobic Endurance; Flexibility; Agility; Telehealth; Strength

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in Vascular Function Following Distance-Based Exercise Program

  14 weeks

• Changes in Atherosclerotic Cardiovascular Disease (ASCVD) Risk Profiles Following a Distance-Based Exercise Program

  14 weeks

Other Outcomes (14)

• Changes in Functional Fitness

  14 weeks

• Estimation of Muscle Strengthening Exercise Session Adherence

  14 weeks

• Estimation of Adherence to Aerobic Physical Activity Guidelines (150 minutes/week)

  14 weeks

Study Arms (1)

12-week Exercise Intervention

EXPERIMENTAL

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

Interventions

12-week home-based exercise intervention BEHAVIORAL

All participants will be given the same 12-week distance-based exercise intervention.

12-week Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jess S. Gorzelitz: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Cardiovascular Diseases; Health Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavior

Study Officials

• Jess Gorzelitz, PHD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcomes assessor will be blinded to exercise status of participant but all participants will receive treatment
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: August 1, 2024
• Study Start: July 23, 2024
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)