Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315569
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-02-18
Brief Title:
The Effect of Exercise at Different Time Intervals on Hyperuricemia
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
The Effect of Exercise at Different Time Intervals on Hyperuricemia
Status:
RECRUITING
Status Verified Date:
2024-01
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 study aim is to explore the correlation between exercise and hyperuricemia find out the metabolic rule of uric acid after exercise and provide scientific evidence and clinical guidance for how to exercise scientifically and reasonably in patients with hyperuricemia This trial is a multicenter prospective randomized controlled clinical trial with 100 participants Inclusion criteria 1 Patients with hyperuricemia fasting uric acid 420μmolL twice on different days 2 Men aged between 18 and 35 3 Able to complete baseline fitness test 3000m run time less than 14 minutes 4 Fully informed consent signed informed consent exclusion criteria 1 Patients with heart liver and kidney insufficiency 2 Subjects suffering from severe or uncontrollable organic diseases may interfere with study parameters such as hypertension hyperlipidemia hyperglycemia tumor cardiovascular lung and digestive diseases 3 Patients with secondary hyperuricemia caused by other diseases 4 Take any drugs that may cause uric acid changes in the past 4 weeks 5 Those who have related motor function or other factors are easy to cause discomfort after exercise 6 Those who have mental illness or communicate do not cooperate during the test
A total of 100 participants participated in the studyGroup A n 50 Group B n 50 The subjects are divided into two groups designated as A and B Following the completion of the grouping all subjects complete the initial 3000 m run The second 3000 m run is performed on the seventh day following the initial run The interval between the third run and the second run in Group A is 24 hours while the interval in Group B is 48 hours During the 48-hour observation period after each exercise the changes of uric acid after exercise were explored To provide scientific evidence and clinical guidance for patients with hyperuricemia how to exercise scientifically and rationally
Patients must meet all inclusion and exclusion criteria to be eligible to participate in the study After determining patients eligibility for the study the researcher should fully explain the nature purpose risks and benefits of the study to the subjects before the study and assure the patients that they have the right to withdraw at any time after agreeing to participate in the study and the subjects should sign a written informed consent after fully considering and agreeing to participate in the study The process of obtaining informed consent should be correctly recorded in all case report forms in this study
Baseline data such as blood uric acid blood biochemistry blood routine urine routine uric acid and demographic characteristics were collected after the patients were enrolled
The patients were randomly divided into two groups Group A and Group B Within 48 hours after each 3000m exercise the subjects blood uric acid was detected after exercise 1 hour 2 hours 3 hours 12 hours 24 hours 36 hours 48 hours
From January 2024 to February 2024 we plan to draft clinical study protocols investigator manuals case reports informed consent forms and other documents and submit them to the Ethics Committee of the research sponsor for review and approval February 2024 - March 2024 Complete the training of all researchers and officially start the research March 2024 - August 2024 Participants were enrolled for the experiment August 2024 - November 2024 collate and collect data conduct statistical analysis and confirm research results
A total of 100 participants participated in the studyGroup A n 50 Group B n 50 The subjects are divided into two groups designated as A and B Following the completion of the grouping all subjects complete the initial 3000 m run The second 3000 m run is performed on the seventh day following the initial run The interval between the third run and the second run in Group A is 24 hours while the interval in Group B is 48 hours During the 48-hour observation period after each exercise the changes of uric acid after exercise were explored To provide scientific evidence and clinical guidance for patients with hyperuricemia how to exercise scientifically and rationally
Patients must meet all inclusion and exclusion criteria to be eligible to participate in the study After determining patients eligibility for the study the researcher should fully explain the nature purpose risks and benefits of the study to the subjects before the study and assure the patients that they have the right to withdraw at any time after agreeing to participate in the study and the subjects should sign a written informed consent after fully considering and agreeing to participate in the study The process of obtaining informed consent should be correctly recorded in all case report forms in this study
Baseline data such as blood uric acid blood biochemistry blood routine urine routine uric acid and demographic characteristics were collected after the patients were enrolled
The patients were randomly divided into two groups Group A and Group B Within 48 hours after each 3000m exercise the subjects blood uric acid was detected after exercise 1 hour 2 hours 3 hours 12 hours 24 hours 36 hours 48 hours
From January 2024 to February 2024 we plan to draft clinical study protocols investigator manuals case reports informed consent forms and other documents and submit them to the Ethics Committee of the research sponsor for review and approval February 2024 - March 2024 Complete the training of all researchers and officially start the research March 2024 - August 2024 Participants were enrolled for the experiment August 2024 - November 2024 collate and collect data conduct statistical analysis and confirm research results
Detailed Description:
None
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