Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961371
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-06-26
Brief Title:
Strength Training for Osteoporosis Prevention During Early Menopause
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Strength Training for Osteoporosis Prevention During Early Menopause
Status:
RECRUITING
Status Verified Date:
2023-11
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:
STOP-EM
Brief Summary:
The goal of this clinical pilot trial is to learn about the feasibility of a high-intensity resistance training intervention in peri- and early menopausal females The main question it aims to answer are
-Is a 9-month resistance training intervention feasible eg recruitment rates protocol adherence attrition
Secondary aims include examining changes in bone health muscle strength and menopausal symptoms
Participants will participate in a 9-month progressive supervised resistance training intervention Researchers will compare secondary outcomes between the exercise group and a wait-list control group
-Is a 9-month resistance training intervention feasible eg recruitment rates protocol adherence attrition
Secondary aims include examining changes in bone health muscle strength and menopausal symptoms
Participants will participate in a 9-month progressive supervised resistance training intervention Researchers will compare secondary outcomes between the exercise group and a wait-list control group
Detailed Description:
The STOP-EM trial will examine a 9-month supervised progressive resistance training program in peri- and early menopausal females Primary outcomes include recruitment rates protocol adherence and attrition A waitlist control group will allow us to examine the effect of the exercise program on bone density structure and strength muscle strength and menopausal symptoms Participants will be randomized to the exercise or control group The exercise group will attend twice weekly in-person supervised progressive resistance training and build up to 80-90 of estimated 1 repetition maximum 1RM The study will take place at the University of Calgary Findings will be used to decide whether to continue to the definitive trial
Study Oversight
Has Oversight DMC:
None
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?:
None