NCT01226342CompletedNot Applicable
Transcutaneous Electrical Muscle Stimulation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
The University Clinic of Pulmonary and Allergic Diseases Golnik2 sites in 1 country19 target enrollmentStarted: January 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Scores on the feasibility scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •chronic obstructive pulmonary disease GOLD stage III or IV
- •acute exacerbation of the disease
Exclusion Criteria
- •contraindications for transcutaneous electrical muscle stimulation
Outcomes
Primary Outcomes
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
- 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))
Investigators
Mitja Lainščak
Professor
The University Clinic of Pulmonary and Allergic Diseases Golnik
Study Sites (2)
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