NCT01321320

Brief Summary

The primary hypothesis for this study is that Myostatin and FHL-1 are important in the development of ICUAP and that changes in activity levels of muscle will modify the levels of expression and activity of these proteins.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 17, 2013

Status Verified

October 1, 2013

Enrollment Period

2.5 years

First QC Date

March 22, 2011

Last Update Submit

October 16, 2013

Conditions

Intensive Care Unit Acquired ParesisMuscle Wasting

Keywords

ICUAPCritical illnessMuscle wastingICU

Outcome Measures

Primary Outcomes (1)

  • Change in muscle myostatin and FHL-1

    1 week

Secondary Outcomes (6)

  • Change in quadriceps cross sectional area

    1 week

  • Change in quadriceps strength

    1 week

  • Change in blood myostatin, miRNA and other markers of muscle breakdown

    1 week

  • Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.

    1 week

  • Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.

    1 week

  • +1 more secondary outcomes

Study Arms (1)

Active stimulation

EXPERIMENTAL

This group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned.

Other: Active muscle stimulation

Interventions

Active muscle stimulationOTHER

Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned).

Active stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High risk patients admitted to AICU.

You may not qualify if:

  • Pre existing neuromuscular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart and Lung Institute, Imperial College

London, United Kingdom

Location

MeSH Terms

Conditions

Muscular AtrophyCritical Illness

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsDisease AttributesPathologic Processes

Study Officials

  • M Polkey

    Royal Brompton Hospital and Imperial College

    PRINCIPAL INVESTIGATOR

  • Susannah Bloch

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 23, 2011

Study Start

April 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 17, 2013

Record last verified: 2013-10

Locations

GB(1)