Biomechanical Properties in Intensive Care Unit (ICU) Sur... | NCT01364714

Studies
Biomechanical Properties in Intensive Care Unit (ICU) Survivors 12-month After Discharge

NCT01364714

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Sep 29, 2017Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Intensive Care (ICU) Myopathy

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010Actual

Primary Completion Date

Feb 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

May 31, 2011

First Submission Date that Met QC Criteria

Jun 1, 2011

First Posted Date

Jun 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2017

Last Update Posted Date

Sep 29, 2017Actual

Name	Class
University of Copenhagen	OTHER

Description Module

Brief Summary

Intensive care unit (ICU) admission is associated with muscle weakness and ICU survivors report persevering limitation of physical capacity for years after discharge. Limited information is available about the underlying biomechanical properties responsible for this muscle function impairment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICU survivors		Male ICU survivors 12 month after discharge
Controls		Age and gender matched controls

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICU length of stay > 72 hours
Informed consent

Exclusion Criteria:

BMI>30
Neuromuscular or psychiatric disease

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

ICU survivors 12 months after discharge compared to age and gender matched controls

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biomechanics and Motor Control Laboratory, Department of Exercise and Sport Sciences, University of Copenhagen		Copenhagen		DK-2100 OE	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009135	Muscular Diseases

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided