Endometrial CancerNCT06534008
Strive Cardio for Endometrial Cancer Survivors
A study testing 12-week home-based exercise intervention in people with Endometrial Cancer and Cardiovascular Diseases, run by Jess S. Gorzelitz at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Cardiovascular Diseases
- What is being tested?
- 12-week home-based exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 17 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometrial Cancer, Cardiovascular Diseases
- Being tested
- 12-week home-based exercise intervention
- Keywords
- Functional Fitness, Arterial stiffness, Health Behaviors, Home-based, Exercise, Muscle Strengthening, Aerobic Endurance, Flexibility, Agility, Telehealth, Strength
- Medical subject headings
- Endometrial Neoplasms, Cardiovascular Diseases, Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week home-based exercise interventionBehavioural
All participants will be given the same 12-week distance-based exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 12-week home-based exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start23 Jul 2024
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jess S. Gorzelitz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jess S. Gorzelitz, University of Iowa
- Investigators
- Jess Gorzelitz, PHD, MS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534008
- Sponsor's protocol ID
- 202311588
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Aerobic and Muscle Strengthening Exercises on Structural and Functional Cardiovascular Adaptations in Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT06534008
- Acronym / sponsor ID
- 202311588
- Conditions
- Endometrial Cancer, Cardiovascular Diseases
- Keywords
- Functional Fitness, Arterial stiffness, Health Behaviors, Home-based, Exercise, Muscle Strengthening, Aerobic Endurance, Flexibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Jess S. GorzelitzUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 12-week Exercise Intervention | Experimental | Behavioral: 12-week home-based exercise interventionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week home-based exercise interventionAll participants will be given the same 12-week distance-based exercise intervention. | Behavioural | 12-week Exercise Intervention |
Primary outcome
Changes in Vascular Stiffness Following Distance-Based Exercise Program
Time frame: 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.
2 secondary outcomes
Changes in Vascular Function Following Distance-Based Exercise Program
Time frame: 14 weeks
Changes in Atherosclerotic Cardiovascular Disease (ASCVD) Risk Profiles Following a Distance-Based Exercise Program
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jess Gorzelitz, PHD, MS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week home-based exercise intervention in people with Endometrial Cancer and Cardiovascular Diseases, run by Jess S. Gorzelitz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Vascular Stiffness Following Distance-Based Exercise Program (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.