NCT01513486

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 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

January 6, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

9 months

First QC Date

January 6, 2012

Last Update Submit

May 20, 2013

Conditions

Disuse AtrophyImmobilizationNeuromuscular Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • muscle mass, muscle fiber size

    three days before immobilization, and directly after immobilization (day of cast removal; day 6)

Secondary Outcomes (1)

  • 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)

Study Arms (2)

Immobilization with NMES

EXPERIMENTAL

Immobilization with daily NMES

Behavioral: immobilization

Immobilization without NMES

PLACEBO COMPARATOR

Immobilization without daily NMES

Behavioral: immobilization

Interventions

immobilizationBEHAVIORAL
Immobilization with NMESImmobilization without NMES

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Muscular Disorders, Atrophic

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Luc JC van Loon, PhD

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 20, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

NL(1)