Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534008
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Strive Cardio for Endometrial Cancer Survivors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Combined Aerobic and Muscle Strengthening Exercises on Structural and Functional Cardiovascular Adaptations in Endometrial Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg detailed exercise manual and exercise training equipment eg 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 participants 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 investigators 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 investigators 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
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 eg detailed exercise manual and exercise training equipment eg 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 participants 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 investigators 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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None