NCT00809120

Brief Summary

The study was designed to test the following hypothesis Patients with high cardio-respiratory response to electrostimulation (ES), high perception of pain during ES and high ES-induced muscle fatigue, have low tolerance to ES (more difficulties to increase intensity during training).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2008

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

Study Start

First participant enrolled

December 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 10, 2010

Status Verified

September 1, 2008

Enrollment Period

8 months

First QC Date

December 16, 2008

Last Update Submit

June 9, 2010

Conditions

COPD

Keywords

ElectrostimulationCOPDToleranceMuscle fatigueCardio-respiratory response

Outcome Measures

Primary Outcomes (1)

  • Tolerance to ES = Change in ES intensity between session 2 and 3 (delta intensity)

    1 week

Secondary Outcomes (5)

  • Cardiorespiratory response during ES

    1 week

  • Muscle fatigue after ES

    1 week

  • Body composition

    1 week

  • Perception of pain at session 2 (symptoms on Visual Analogic Scale)

    1 week

  • Plasmatic proteins after ES

    1 week

Interventions

Neuromuscular Electrical stimulator (Cefar rehab 4 pro)DEVICE

50Hz 30 min 7 sessions

Also known as: NMES

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is diagnosed with COPD.
  • years-old and older
  • Currently or previously smoking with a smoking history of at least 10 pack-years
  • Subject understands and is able to read and write French or English

You may not qualify if:

  • absence of neuromuscular pathology
  • absence of vascular pathology
  • absence of dermatosis on legs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Laval

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (1)

  • Vivodtzev I, Rivard B, Gagnon P, Mainguy V, Dube A, Belanger M, Jean B, Maltais F. Tolerance and physiological correlates of neuromuscular electrical stimulation in COPD: a pilot study. PLoS One. 2014 May 9;9(5):e94850. doi: 10.1371/journal.pone.0094850. eCollection 2014.

    PMID: 24817528DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

December 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

June 10, 2010

Record last verified: 2008-09

Locations

CA(1)