Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510998
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Isometric Resistance Exercise for Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness and Mechanisms of Isometric Resistance Exercise to Reduce Blood Pressure in a Chinese Population a Randomized-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Background Isometric resistance exercises IREs have great potential to improve blood pressure BP control However the effectiveness of IREs in reducing HT is still unknown because their hypotensive effects have not been detected using ambulatory BP measurements ABPM which are the current standard for BP measurement
Methods This first adequately-powered RCT will involve 390 patients with HT who do not meet the current physical activity guidelines defined by the World Health Organization Participants will be randomly assigned in a 11 ratio using stratified and blocked randomization to either the IRE wall squat group or stretching exercise active control group A well-structured widely accepted and validated 24-week wall squat program 2 minutes per exercise 2 minutes of rest between sets and 3 sessions per week will be implemented as it has been commonly used in previous research Adherence to the program will be monitored using smartwatches and regular contact with patients through social media will help ensure adherence All patients will be followed up for 1 year to investigate the long-term effects of IREs on BP Control group will receive exact same treatment except that IRE is replaced by frequency-matched and time-matched stretching exercise The primary outcome measure will be systolic daytime ABPM BP at 24 weeks Secondary outcome measures will include other BP and ABPM parameters at 12 weeks 24weeks and 1year cfPWV at baseline 24 weeks and 1year and FMD at baseline and 24weeks Safety data will be collected and reported
Methods This first adequately-powered RCT will involve 390 patients with HT who do not meet the current physical activity guidelines defined by the World Health Organization Participants will be randomly assigned in a 11 ratio using stratified and blocked randomization to either the IRE wall squat group or stretching exercise active control group A well-structured widely accepted and validated 24-week wall squat program 2 minutes per exercise 2 minutes of rest between sets and 3 sessions per week will be implemented as it has been commonly used in previous research Adherence to the program will be monitored using smartwatches and regular contact with patients through social media will help ensure adherence All patients will be followed up for 1 year to investigate the long-term effects of IREs on BP Control group will receive exact same treatment except that IRE is replaced by frequency-matched and time-matched stretching exercise The primary outcome measure will be systolic daytime ABPM BP at 24 weeks Secondary outcome measures will include other BP and ABPM parameters at 12 weeks 24weeks and 1year cfPWV at baseline 24 weeks and 1year and FMD at baseline and 24weeks Safety data will be collected and reported
Detailed Description:
None
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