Back to resultsTranscutaneous Electrical Muscle Stimulation In Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Transcutaneous electrical muscle stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease
Eligibility 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
Sites / Locations
- University Clinic Golnik
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TCEMS
Arm Description
Patients who will receive transcutaneous electrical muscle stimulation
Outcomes
Primary Outcome Measures
Scores on the feasibility scale
Patients will be followed from admission until discharge
Secondary Outcome Measures
Scores on the patient satisfaction scale
Patients will be followed from admission until discharge
Number of patients with adverse events as a measure of Safety and tolerability
Patients will be followed from admission until discharge
Health related quality of life on the St. George respiratory questionnaire
Patients will be followed from admission until discharge
Dyspnea on the MRC dyspnea scale
Patients will be followed from admission until discharge
Patient symptom scores on the Functional assessment of chronic illness therapy questionaire
Patients will be followed from admission until discharge
Full Information
NCT ID
NCT01226342
First Posted
October 18, 2010
Last Updated
April 10, 2013
Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
1. Study Identification
Unique Protocol Identification Number
NCT01226342
Brief Title
Transcutaneous Electrical Muscle Stimulation In Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Transcutaneous Electrical Muscle Stimulation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TCEMS
Arm Type
Experimental
Arm Description
Patients who will receive transcutaneous electrical muscle stimulation
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical muscle stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scores on the feasibility scale
Description
Patients will be followed from admission until discharge
Time Frame
10 days (avarage time from admission to discharge)
Secondary Outcome Measure Information:
Title
Scores on the patient satisfaction scale
Description
Patients will be followed from admission until discharge
Time Frame
10 days (avarage time from admission to discharge)
Title
Number of patients with adverse events as a measure of Safety and tolerability
Description
Patients will be followed from admission until discharge
Time Frame
10 days (avarage time from admission to discharge)
Title
Health related quality of life on the St. George respiratory questionnaire
Description
Patients will be followed from admission until discharge
Time Frame
10 days (avarage time from admission to discharge)
Title
Dyspnea on the MRC dyspnea scale
Description
Patients will be followed from admission until discharge
Time Frame
10 days (avarage time from admission to discharge)
Title
Patient symptom scores on the Functional assessment of chronic illness therapy questionaire
Description
Patients will be followed from admission until discharge
Time Frame
10 days (avarage time from admission to discharge)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitja Lainscak, MD, PhD
Organizational Affiliation
University Clinic Golnik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mitja Kosnik, MD, PhD
Organizational Affiliation
contraindications for TCEMS
Official's Role
Study Chair
Facility Information:
Facility Name
University Clinic Golnik
City
Golnik
ZIP/Postal Code
SI-4204
Country
Slovenia
12. IPD Sharing Statement
Citations:
PubMed Identifier
21607562
Citation
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.
Results Reference
result
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Transcutaneous Electrical Muscle Stimulation In Chronic Obstructive Pulmonary Disease (COPD)
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