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

NCT01226342 | Completed

• 1 other identifier: Golnik-COPD-TENS-1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Scores on the feasibility scale

  Patients will be followed from admission until discharge

  10 days (avarage time from admission to discharge)

Secondary Outcomes (5)

• Scores on the patient satisfaction scale

  10 days (avarage time from admission to discharge)

• Number of patients with adverse events as a measure of Safety and tolerability

  10 days (avarage time from admission to discharge)

• Health related quality of life on the St. George respiratory questionnaire

  10 days (avarage time from admission to discharge)

• Dyspnea on the MRC dyspnea scale

  10 days (avarage time from admission to discharge)

• Patient symptom scores on the Functional assessment of chronic illness therapy questionaire

  10 days (avarage time from admission to discharge)

Study Arms (1)

TCEMS

EXPERIMENTAL

Patients who will receive transcutaneous electrical muscle stimulation

Device: Transcutaneous electrical muscle stimulation

Interventions

Transcutaneous electrical muscle stimulation 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.

TCEMS

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• contraindications for transcutaneous electrical muscle stimulation

Sponsors & Collaborators

• The University Clinic of Pulmonary and Allergic Diseases Golnik: lead

Study Sites (1)

University Clinic Golnik

Golnik, SI-4204, Slovenia

Location

Related 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.

  PMID: 21607562 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mitja Lainscak, MD, PhD

  University Clinic Golnik

  PRINCIPAL INVESTIGATOR

• Mitja Kosnik, MD, PhD

  contraindications for TCEMS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 22, 2010
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

SL (1)