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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier:
NCT01226342
First received: October 18, 2010
Last updated: April 10, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    Patients will be followed from admission until discharge

  • Dyspnea on the MRC dyspnea scale [ Time Frame: 10 days (avarage time from admission to discharge) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 18, 2010
Last Updated: April 10, 2013
Health Authority: Slovenia: Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014