Chronic Obstructive Pulmonary DiseaseNCT01226342
Transcutaneous Electrical Muscle Stimulation In Chronic Obstructive Pulmonary Disease (COPD)
A study testing Transcutaneous electrical muscle stimulation in people with Chronic Obstructive Pulmonary Disease, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
Trial summary
Transcutaneous electrical muscle stimulation (TCEMS) is well established intervention for rehabilitation of clinically stable patients with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Transcutaneous electrical muscle stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSlovenia
- Study dates
- Jan 2009to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic obstructive pulmonary disease GOLD stage III or IV
- acute exacerbation of the disease
Who cannot join
- contraindications for transcutaneous electrical muscle stimulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Transcutaneous electrical muscle stimulation
- Keywords
- Chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical muscle stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TCEMS | Experimental | Patients who will receive transcutaneous electrical muscle stimulation Receives: Device: Transcutaneous electrical muscle stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the feasibility scale
Patients will be followed from admission until discharge
Measured: 10 days (avarage time from admission to discharge)
Secondary outcomes (5)
Scores on the patient satisfaction scale
Patients will be followed from admission until discharge
Measured: 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
Measured: 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
Measured: 10 days (avarage time from admission to discharge)
Dyspnea on the MRC dyspnea scale
Patients will be followed from admission until discharge
Measured: 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
Measured: 10 days (avarage time from admission to discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases Golnik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitja Lainščak, The University Clinic of Pulmonary and Allergic Diseases Golnik
- Investigators
- Mitja Lainscak, MD, PhD, Principal investigator, University Clinic GolnikMitja Kosnik, MD, PhD, Study chair, contraindications for TCEMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226342
- Sponsor's protocol ID
- Golnik-COPD-TENS-1
- Status last verified
- Apr 2013
- First submitted
- 18 Oct 2010
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21607562
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Muscle Stimulation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01226342
- Acronym / sponsor ID
- Golnik-COPD-TENS-1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases GolnikUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCEMS | Experimental | Device: Transcutaneous electrical muscle stimulationPatients who will receive transcutaneous electrical muscle stimulation |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic obstructive pulmonary disease GOLD stage III or IV
- acute exacerbation of the disease
Key exclusion criteria (1 listed)
- contraindications for transcutaneous electrical muscle stimulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical muscle stimulationOn 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. | Device | TCEMS |
Primary outcome
Scores on the feasibility scale
Time frame: 10 days (avarage time from admission to discharge)
Patients will be followed from admission until discharge
5 secondary outcomes
Scores on the patient satisfaction scale
Time frame: 10 days (avarage time from admission to discharge)
Number of patients with adverse events as a measure of Safety and tolerability
Time frame: 10 days (avarage time from admission to discharge)
Health related quality of life on the St. George respiratory questionnaire
Time frame: 10 days (avarage time from admission to discharge)
Dyspnea on the MRC dyspnea scale
Time frame: 10 days (avarage time from admission to discharge)
Patient symptom scores on the Functional assessment of chronic illness therapy questionaire
Time frame: 10 days (avarage time from admission to discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
- Results publication: PubMed 21607562Meglic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitja Lainscak, MD, PhD principal investigator
University Clinic Golnik
Mitja Kosnik, MD, PhD study chair
contraindications for TCEMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical muscle stimulation in people with Chronic Obstructive Pulmonary Disease, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on the feasibility scale (time frame: 10 days (avarage time from admission to discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.