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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Transcutaneous electrical muscle stimulation

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Golnik, Slovenia, SI-4204
    • University Clinic Golnik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores on the feasibility scale	Patients will be followed from admission until discharge	10 days (avarage time from admission to discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores on the patient satisfaction scale	Patients will be followed from admission until discharge	10 days (avarage time from admission to discharge)
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)
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)
Dyspnea on the MRC dyspnea scale	Patients will be followed from admission until discharge	10 days (avarage time from admission to discharge)
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)

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: October 21, 2010
• First Posted (Estimate): October 22, 2010

Study Record Updates

• Last Update Posted (Estimate): April 11, 2013
• Last Update Submitted That Met QC Criteria: April 10, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Golnik-COPD-TENS-1