Skip to main content
Clinical Trials/NCT06534008
NCT06534008CompletedNot Applicable

The Effect of Combined Aerobic and Muscle Strengthening Exercises on Structural and Functional Cardiovascular Adaptations in Endometrial Cancer Survivors

Jess S. Gorzelitz2 sites in 1 country33 target enrollmentStarted: July 23, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
33
Locations
2
Primary Endpoint
Changes in Vascular Stiffness Following Distance-Based Exercise Program

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Masking Description

Outcomes assessor will be blinded to exercise status of participant but all participants will receive treatment

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor
Jess S. Gorzelitz
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Jess S. Gorzelitz

Assistant Professor

University of Iowa

Study Sites (2)

Loading locations...

Similar Trials