Evaluation of Utility Quadriceps Magnetic Stimulation in COPD (Chronic Obstructive Pulmonary Disease) Patients After Hospital Exacerbation (COPD)
Recruitment status was: Not yet recruiting
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.
|COPD COPD Exacerbation||Device: Repetitive magnetic stimulation of the quadriceps muscle||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]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 ]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 ]One week after hospital release patients are evaluated and initiate treatment with intense magnetic stimulation or placebo. Measurements are repeated after 3 months.
|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)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01264978
|Contact: Victor Bustamantefirstname.lastname@example.org|
|Contact: Juan B. Gáldiz, PhD||0034946006000 ext 2110||Juanbautista.email@example.com|
|Hospital de Cruces||Not yet recruiting|
|Barakaldo, Bizkaia, Spain, 48913|
|Contact: Juan B Galdiz, PhD 0034946006510 ext 2110 firstname.lastname@example.org|
|Contact: Victor Bustamante 0034944006000 email@example.com|
|Principal Investigator: Juan B Galdiz, PhD|