Skip to main content
OpenTrials
Completed

NCT Number: NCT01226342

Transcutaneous Electrical Muscle Stimulation In 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic Golnik

Golnik, SI-4204, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • contraindications for transcutaneous electrical muscle stimulation

Treatment and study plan

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.

Primary outcomes

  1. Scores on the feasibility scale

    Time frame: 10 days (avarage time from admission to discharge)

    Patients will be followed from admission until discharge

Secondary outcomes

  1. Scores on the patient satisfaction scale

    Time frame: 10 days (avarage time from admission to discharge)

    Patients will be followed from admission until discharge

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

    Time frame: 10 days (avarage time from admission to discharge)

    Patients will be followed from admission until discharge

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

    Time frame: 10 days (avarage time from admission to discharge)

    Patients will be followed from admission until discharge

  4. Dyspnea on the MRC dyspnea scale

    Time frame: 10 days (avarage time from admission to discharge)

    Patients will be followed from admission until discharge

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

    Time frame: 10 days (avarage time from admission to discharge)

    Patients will be followed from admission until discharge

Sponsors and collaborators

Lead sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 22, 2010
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.