Clinical trial NCT06534008: Strive Cardio for Endometrial Cancer Survivors
Official title: The Effect of Combined Aerobic and Muscle Strengthening Exercises on Structural and Functional Cardiovascular Adaptations in Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Cardiovascular Diseases
Keywords: Functional Fitness
Arterial stiffness
Health Behaviors
Home-based
Exercise
Muscle Strengthening
Aerobic Endurance
Flexibility
Agility
Telehealth
Strength
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Vascular Stiffness Following Distance-Based Exercise Program
timeFrame: 14 weeks
Secondary outcomes:
measure: Changes in Vascular Function Following Distance-Based Exercise Program
timeFrame: 14 weeks
measure: Changes in Atherosclerotic Cardiovascular Disease (ASCVD) Risk Profiles Following a Distance-Based Exercise Program
timeFrame: 14 weeks
Other outcomes:
measure: Changes in Functional Fitness
timeFrame: 14 weeks
measure: Estimation of Muscle Strengthening Exercise Session Adherence
timeFrame: 14 weeks
measure: Estimation of Adherence to Aerobic Physical Activity Guidelines (150 minutes/week)
timeFrame: 14 weeks
measure: Estimation of Tele-Coaching Adherence
timeFrame: 14 weeks
measure: Estimation of Intervention Acceptability
timeFrame: 14 weeks
measure: Change in Waist to Hip ratio (WHR)
timeFrame: 14 weeks
measure: Changes in body weight
timeFrame: 14 weeks
measure: Changes in Ambulatory Activity Levels
timeFrame: 2 weeks
measure: Changes in self-efficacy relating to aerobic exercise
timeFrame: 14 weeks
measure: Changes in self-efficacy relating to strength exercises
timeFrame: 14 weeks
measure: Changes in the Basic Psychological Needs in Exercise Scale
timeFrame: 14 weeks
measure: Changes in the Exercise Regulations Questionnaire
timeFrame: 14 weeks
measure: Changes in the Multidimensional Scale of Perceived Social Support
timeFrame: 14 weeks
measure: Changes in the Food Frequency Questionnaire
timeFrame: 14 weeks
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Jess Gorzelitz, PHD, MS
role: PRINCIPAL_INVESTIGATOR
References: