NCT01167283

Brief Summary

This study was designed to test the following hypothesis: To investigate whether COPD muscles can respond to stimuli in terms of changes in fiber-type distribution.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
Last Updated

August 6, 2010

Status Verified

July 1, 2010

Enrollment Period

3.8 years

First QC Date

July 13, 2010

Last Update Submit

August 5, 2010

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Fiber-type distribution

    Typology was evaluated by immunohistochemistry

    6 to 8 weeks

Secondary Outcomes (1)

  • Change in the strength of the quadriceps over the 6-week electrostimulation program

    6 to 8 weeks

Study Arms (2)

Electrostimulation

ACTIVE COMPARATOR

Neuromuscular electrical stimulation

Device: Electrostimulation

Sham stimulation

SHAM COMPARATOR

Sham stimulation

Device: Sham stimulation

Interventions

ElectrostimulationDEVICE

Electrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week

Also known as: NMES
Electrostimulation
Sham stimulationDEVICE

Sham stimulation: 1 h; 5 times/week

Also known as: Sham
Sham stimulation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients during or after exacerbation

You may not qualify if:

  • Comorbidities that could limit exercise training
  • Obesity (body mass index \[BMI\] \> 30 kg/m²)
  • Neuromuscular disease
  • Pacemaker implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier OJ Jonquet, PU-PH

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 22, 2010

Study Start

July 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 6, 2010

Record last verified: 2010-07