RhabdomyolysisNCT03737513
Exercise-induced Collective Rhabdomyolysis
An observational study of Rhabdomyolysis, run by Haitao Tu at 1 site in China.
Trial summary
Rhabdomyolysis, which is a characteristic occurrence in associated with muscle cell necrosis, develops due to various causes.The investigators herein report a rare case of collective rhabdomyolysis after high intensity resistance training, including 35 teenagers（participants），in which markedly elevated levels of serum… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rhabdomyolysis
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2018to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Students who participated in this military training from the same school
Who may be able to join
- Clinical diagnosis of rhabdomyolysis;
- Caused by military training;
- Informed consent；
- Must be able to cooperate with blood test.
Who cannot join
- Caused by drugs and other reasons;
- No hospitalization event
Trial locations and contacts
1 site in 1 country.
China1 site
Yueqing Hospital Affiliated to Wenzhou Medical University
Yueqing, Zhejiang, 325600
About this study
Rhabdomyolysis, which is a characteristic occurrence in associated with muscle cell necrosis, develops due to various causes.The investigators herein report a rare case of collective rhabdomyolysis after high intensity resistance training, including 35 teenagers（participants），in which markedly elevated levels of serum creatine kinase (CK) and serum myoglobin were observed. This high intensity resistance trainings is a part of Military Training(MT)，which all the middle school students must finish before admission。
- Conditions
- Rhabdomyolysis
- Keywords
- Rhabdomyolysis, Military Training
- Medical subject headings
- Rhabdomyolysis
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatine kinase；
Change in serum creatine kinase at 3 months
Measured: 3 months
serum myoglobin
At the time of discharge
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start9 Sep 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haitao Tu
- Sponsor type
- University, hospital or other
- Collaborators
- Yueqing Hospital Affiliated to Wenzhou Medical University
- Responsible party
- Sponsor-investigator, Haitao Tu, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737513
- Sponsor's protocol ID
- 2018110801
- Status last verified
- Jun 2019
- First submitted
- 8 Nov 2018
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-induced Collective Rhabdomyolysis
- ClinicalTrials.gov ID
- NCT03737513
- Acronym / sponsor ID
- 2018110801
- Conditions
- Rhabdomyolysis
- Keywords
- Rhabdomyolysis, Military Training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Haitao TuUniversity, hospital or other
- Collaborators
- Yueqing Hospital Affiliated to Wenzhou Medical University
- Study start
- 9 Sep 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rhabdomyolysis, which is a characteristic occurrence in associated with muscle cell necrosis, develops due to various causes.The investigators herein report a rare case of collective rhabdomyolysis after high intensity resistance training, including 35 teenagers（participants），in which markedly elevated levels of serum creatine kinase (CK) and serum myoglobin were observed. This high intensity resistance trainings is a part of Military Training(MT)，which all the middle school students must finish before admission。
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Students who participated in this military training from the same school
Key inclusion criteria (4 listed)
- Clinical diagnosis of rhabdomyolysis;
- Caused by military training;
- Informed consent；
- Must be able to cooperate with blood test.
Key exclusion criteria (2 listed)
- Caused by drugs and other reasons;
- No hospitalization event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum creatine kinase；
Time frame: 3 months
Change in serum creatine kinase at 3 months
serum myoglobin
Time frame: 1 week
At the time of discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhabdomyolysis, run by Haitao Tu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum creatine kinase； (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.