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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Transcutaneous Electrical Muscle Stimulation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226342
• Other study ID #: Golnik-COPD-TENS-1
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: April 10, 2013
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: April 2013
• Source: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

• chronic obstructive pulmonary disease GOLD stage III or IV

• acute exacerbation of the disease

Exclusion Criteria:

• contraindications for transcutaneous electrical muscle stimulation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Slovenia	University Clinic Golnik	Golnik

Sponsors (1)

Lead Sponsor	Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik

Country where clinical trial is conducted

Slovenia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on the feasibility scale	Patients will be followed from admission until discharge	10 days (avarage time from admission to discharge)	No
Secondary	Scores on the patient satisfaction scale	Patients will be followed from admission until discharge	10 days (avarage time from admission to discharge)	No
Secondary	Number of patients with adverse events as a measure of Safety and tolerability	Patients will be followed from admission until discharge	10 days (avarage time from admission to discharge)	Yes
Secondary	Health related quality of life on the St. George respiratory questionnaire	Patients will be followed from admission until discharge	10 days (avarage time from admission to discharge)	No
Secondary	Dyspnea on the MRC dyspnea scale	Patients will be followed from admission until discharge	10 days (avarage time from admission to discharge)	No
Secondary	Patient symptom scores on the Functional assessment of chronic illness therapy questionaire	Patients will be followed from admission until discharge	10 days (avarage time from admission to discharge)	No