Transcutaneous Electrical Muscle Stimulation In Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01226342

Last Updated: 2013-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-10-31

Brief Summary

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Transcutaneous electrical muscle stimulation (TCEMS) is well established intervention for rehabilitation of clinically stable patients with chronic obstructive pulmonary disease.

The investigators have conceived this study to test whether TCEMS is feasible and tolerated by patients experiencing severe physical and psychical challenge of acutely exacerbated COPD.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TCEMS

Patients who will receive transcutaneous electrical muscle stimulation

Group Type EXPERIMENTAL

Transcutaneous electrical muscle stimulation

Intervention Type DEVICE

On the first hospitalization day patients received lower extremity TCEMS. We used GymnaUniphy device (GymnaUniphy N.V., 2004, 3740 Bilzen, Belgium) with four surface patch electrodes applied over each lower extremity quadriceps muscle. Patients were in the supine position and were advised to relax during sessions. A prespecified program for lower extremity strength training in sessions of 25 minutes, twice a day (first training in the morning, second in the afternoon, with minimal time difference of 6 hours) was performed six days per week during the hospitalization.

Interventions

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Transcutaneous electrical muscle stimulation

On the first hospitalization day patients received lower extremity TCEMS. We used GymnaUniphy device (GymnaUniphy N.V., 2004, 3740 Bilzen, Belgium) with four surface patch electrodes applied over each lower extremity quadriceps muscle. Patients were in the supine position and were advised to relax during sessions. A prespecified program for lower extremity strength training in sessions of 25 minutes, twice a day (first training in the morning, second in the afternoon, with minimal time difference of 6 hours) was performed six days per week during the hospitalization.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* chronic obstructive pulmonary disease GOLD stage III or IV
* acute exacerbation of the disease

Exclusion Criteria

* contraindications for transcutaneous electrical muscle stimulation
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role lead

Responsible Party

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Mitja Lainščak

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mitja Lainscak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Clinic Golnik

Mitja Kosnik, MD, PhD

Role: STUDY_CHAIR

contraindications for TCEMS

Locations

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University Clinic Golnik

Golnik, , Slovenia

Site Status

Countries

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Slovenia

References

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Meglic U, Sorli J, Kosnik M, Lainscak M. Feasibility of transcutaneous electrical muscle stimulation in acute exacerbation of COPD. Wien Klin Wochenschr. 2011 Jun;123(11-12):384-7. doi: 10.1007/s00508-011-1587-2. Epub 2011 May 25.

Reference Type RESULT
PMID: 21607562 (View on PubMed)

Other Identifiers

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Golnik-COPD-TENS-1

Identifier Type: -

Identifier Source: org_study_id

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