Strive Cardio for Endometrial Cancer Survivors
NCT Number: NCT06534008
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endometrial Cancer|Cardiovascular Diseases
Interventions: BEHAVIORAL: 12-week home-based exercise intervention
Sponsor: Jess S. Gorzelitz
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2025-06

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.

Primary Outcome Measures: 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: 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: 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