Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-28 @ 10:41 AM
Study NCT ID:
NCT04013568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-10
First Post:
2019-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Post-Diagnosis of Breast Cancer
Sponsor:
University of Hawaii
Organization:
Study Overview
Official Title:
A Pilot Study: The Effect of Longitudinal Exercise Programming in Breast Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.
Detailed Description:
The study is enrolling breast cancer patients up to 2 years after their diagnosis in a 12-week exercise program. The participants will either participate in: Group 1-participating in an exercise program with biometric evaluations or Group 2-biometric evaluations but not participating in the exercise program. At the end of the 12-week exercise program, participants in Group 1 will be randomized to either: a) continuing with exercise group classes or b) continuing with exercise individual classes. Both Group 1a and 1b participants will be followed for the remainder of the year and be evaluated for continued physical activity. All Group study participants' biometrics will be assessed at baseline and at the end of 12-weeks, with continued annual medical review follow-up for a total of 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: