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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01226342
First Posted: October 22, 2010
Last Update Posted: April 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease Device: Transcutaneous electrical muscle stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcutaneous Electrical Muscle Stimulation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik:

Primary Outcome Measures:
  • Scores on the feasibility scale [ Time Frame: 10 days (avarage time from admission to discharge) ]
    Patients will be followed from admission until discharge


Secondary Outcome Measures:
  • Scores on the patient satisfaction scale [ Time Frame: 10 days (avarage time from admission to discharge) ]
    Patients will be followed from admission until discharge

  • Number of patients with adverse events as a measure of Safety and tolerability [ Time Frame: 10 days (avarage time from admission to discharge) ]
    Patients will be followed from admission until discharge

  • Health related quality of life on the St. George respiratory questionnaire [ Time Frame: 10 days (avarage time from admission to discharge) ]
    Patients will be followed from admission until discharge

  • Dyspnea on the MRC dyspnea scale [ Time Frame: 10 days (avarage time from admission to discharge) ]
    Patients will be followed from admission until discharge

  • Patient symptom scores on the Functional assessment of chronic illness therapy questionaire [ Time Frame: 10 days (avarage time from admission to discharge) ]
    Patients will be followed from admission until discharge


Enrollment: 19
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TCEMS
Patients who will receive transcutaneous electrical muscle stimulation
Device: 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.

  Eligibility

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindications for transcutaneous electrical muscle stimulation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226342


Locations
Slovenia
University Clinic Golnik
Golnik, Slovenia, SI-4204
Sponsors and Collaborators
The University Clinic of Pulmonary and Allergic Diseases Golnik
Investigators
Principal Investigator: Mitja Lainscak, MD, PhD University Clinic Golnik
Study Chair: Mitja Kosnik, MD, PhD contraindications for TCEMS
  More Information

Publications:
Responsible Party: Mitja Lainščak, Professor, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier: NCT01226342     History of Changes
Other Study ID Numbers: Golnik-COPD-TENS-1
First Submitted: October 18, 2010
First Posted: October 22, 2010
Last Update Posted: April 11, 2013
Last Verified: April 2013

Keywords provided by Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik:
Chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases