Electrical Stimulation During Immobilization | NCT01513486

Studies
Electrical Stimulation During Immobilization

NCT01513486

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

May 22, 2013Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Disuse Atrophy
Immobilization
Neuromuscular Electrical Stimulation

Interventions

immobilization

Countries

Netherlands

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

May 2013

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

Mar 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jan 6, 2012

First Submission Date that Met QC Criteria

Jan 16, 2012

First Posted Date

Jan 20, 2012Estimated

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

May 20, 2013

Last Update Posted Date

May 22, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lex Verdijk, Assistant Professor, Maastricht University Medical CenterPrincipal Investigator

Lead Sponsor

Maastricht University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In the present study, the effects of 5 days of lower limb immobilization with or without daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics will be determined.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immobilization with NMES	Experimental	Immobilization with daily NMES	Behavioral: immobilization
Immobilization without NMES	Placebo Comparator	Immobilization without daily NMES	Behavioral: immobilization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
immobilization	Behavioral		Immobilization with NMES Immobilization without NMES

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
muscle mass, muscle fiber size		three days before immobilization, and directly after immobilization (day of cast removal; day 6)

Secondary Outcomes

Measure	Description	Time Frame
muscle strength measured by quadriceps 1-Repetition Maximum by Leg Extension		three days before immobilization, and directly after immobilization (day of cast removal; day 6)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male
Aged from 18-35 years
18.5 < BMI < 30 kg/m2

Exclusion Criteria:

Smoking
Performing regular resistance training in the previous 6 months
Hypertension (according to WHO criteria) [46] and/or cardiovascular disease
Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
Use of any prescribed medication
Type 2 diabetes mellitus
Any family history of thrombosis
All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
Myocardial infarction within the last 3 years
Use of anti-coagulants

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luc JC van Loon, PhD	Maastricht UMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Centre		Maastricht			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D020966	Muscular Disorders, Atrophic

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007103	Immobilization

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided