Evaluation of Utility Quadriceps Magnetic Stimulation in COPD (Chronic Obstructive Pulmonary Disease) Patients After Hospital Exacerbation
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Purpose
The aims of this study are:1.To evaluate the utility of quadriceps RMNMS (repetitive magnetic neuromuscular stimulation) in the evolution of COPD patients after hospital admission for acute exacerbation.2 To evaluate the time schedule of recovery changes in muscle parameters ,exercise capacity and quality of life after acute exacerbation. 3.To test the use of this new method of training in acute clinical situations. Patients: COPD patients admitted to the Hospital with acute exacerbation. Group 1: RMNMS Treatment .Group 2 : sham RMNMS treatment. Randomized assignment by minimization method. PROTOCOL Training Group: 10 days after discharge and during 8 weeks, 2-3 days/week.
Measures: Spirometry, Plethysmography ,Diffusion Test. Main outcomes: Exercise test (Six minutes walking distance). Muscle function: MVC. Health related quality of life.
| Condition | Intervention | Phase |
|---|---|---|
|
COPD COPD Exacerbation |
Device: Repetitive magnetic stimulation of the quadriceps muscle |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of Utility Quadriceps Magnetic Stimulation in COPD (Chronic Obstructive Pulmonary Disease) Patients After Hospital Exacerbation |
- Six minute walking distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]One week after hospital release patients are evaluated and initiate treatment with intense magnetic stimulation or placebo. Measurements are repeated after 3 months.
- quality of life CRQ [ Time Frame: 3 months ] [ Designated as safety issue: No ]One week after hospital release patients are evaluated and initiate treatment with intense magnetic stimulation or placebo. Measurements are repeated after 3 months.
- Maximal voluntary contraction of the quadriceps [ Time Frame: three months ] [ Designated as safety issue: No ]One week after hospital release patients are evaluated and initiate treatment with intense magnetic stimulation or placebo. Measurements are repeated after 3 months.
| Estimated Enrollment: | 32 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: repetitive neuromuscular stimulation
repetitive neuromuscular stimulation of the quadriceps arm are patients actively stimulated at increasing intensity to afford maximal contraction during training sessions
|
Device: Repetitive magnetic stimulation of the quadriceps muscle
During 8 weeks, 7-10 days after hospital release, patients will receive repetitive magnetic stimulation sessions, 15 minutes on each thigh, alternatively two and three days /week. Coil location: centered on the union between upper and lower two thirds of the vastus lateralis. Stimulation bursts at 10-7 HZ lasting 2 seconds, followed by 4 seconds rest. Intensity will be from 40 to 70% of maximal output, adjusting frequency so that the coil does not overheat, (more than 41ºC). Coils are cooled down to 5ºC before sessions. Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical and functional diagnosis of COPD.
- Hospital admission because of COPD exacerbation in respiratory department, ICU or emergency department
- Hospital discharge.
Exclusion Criteria:
- Cardiac pacemaker.
- Exacerbation because of major Heart disease or pulmonary embolism.
- Lung cancer or disseminated neoplasic disease.
- Severe renal or hepatic disease.
- neurological disease, musculoskeletal or cardiovascular or on any treatment that might interfere with the completion of the protocol and the assessment of functional outcomes.
Contacts and Locations| Contact: Victor Bustamante | 0034617232750 | victor.bustamantemadariaga@osakidetza.net |
| Contact: Juan B. Gáldiz, PhD | 0034946006000 ext 2110 | Juanbautista.galdiziturri@osakidetza.net |
| Spain | |
| Hospital de Cruces | Not yet recruiting |
| Barakaldo, Bizkaia, Spain, 48913 | |
| Contact: Juan B Galdiz, PhD 0034946006510 ext 2110 juanbautista.galdiziturri@osakidetza.net | |
| Contact: Victor Bustamante 0034944006000 victor.bustamantemadariaga@osakidetza.net | |
| Principal Investigator: Juan B Galdiz, PhD | |
More Information
Publications:
| Responsible Party: | Juan Bautista Gáldiz, Hospital de Cruces. Osakidetza |
| ClinicalTrials.gov Identifier: | NCT01264978 History of Changes |
| Other Study ID Numbers: | GV2009111087, GV 2009111087 |
| Study First Received: | December 21, 2010 |
| Last Updated: | December 21, 2010 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Hospital de Cruces:
|
COPD Rehabilitation Neuromuscular stimulation Quadriceps muscle Magnetic stimulation |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on October 18, 2012
