Evaluation of Utility Quadriceps Magnetic Stimulation in COPD (Chronic Obstructive Pulmonary Disease) Patients After Hospital Exacerbation
COPD
2 other identifiers
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2010
CompletedFirst Posted
Study publicly available on registry
December 22, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedDecember 22, 2010
December 1, 2010
1.4 years
December 21, 2010
December 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Six minute walking distance
One week after hospital release patients are evaluated and initiate treatment with intense magnetic stimulation or placebo. Measurements are repeated after 3 months.
3 months
Secondary Outcomes (2)
quality of life CRQ
3 months
Maximal voluntary contraction of the quadriceps
three months
Study Arms (1)
repetitive neuromuscular stimulation
EXPERIMENTALrepetitive neuromuscular stimulation of the quadriceps arm are patients actively stimulated at increasing intensity to afford maximal contraction during training sessions
Interventions
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.
Eligibility Criteria
You may qualify if:
- Clinical and functional diagnosis of COPD.
- Hospital admission because of COPD exacerbation in respiratory department, ICU or emergency department
- Hospital discharge.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital de Cruceslead
- Basurto hospitalcollaborator
- Euskal Herriko Unibertsitatea. Universidad del Pais Vasco.collaborator
- Osakidetzacollaborator
Study Sites (1)
Hospital de Cruces
Barakaldo, Bizkaia, 48913, Spain
Related Publications (5)
Coronell C, Orozco-Levi M, Mendez R, Ramirez-Sarmiento A, Galdiz JB, Gea J. Relevance of assessing quadriceps endurance in patients with COPD. Eur Respir J. 2004 Jul;24(1):129-36. doi: 10.1183/09031936.04.00079603.
PMID: 15293615BACKGROUNDBarreiro E, Schols AM, Polkey MI, Galdiz JB, Gosker HR, Swallow EB, Coronell C, Gea J; ENIGMA in COPD project. Cytokine profile in quadriceps muscles of patients with severe COPD. Thorax. 2008 Feb;63(2):100-7. doi: 10.1136/thx.2007.078030. Epub 2007 Sep 17.
PMID: 17875568BACKGROUNDBustamante V, Casanova J, Lopez de Santamaria E, Mas S, Sellares J, Gea J, Galdiz JB, Barreiro E. Redox balance following magnetic stimulation training in the quadriceps of patients with severe COPD. Free Radic Res. 2008 Nov;42(11-12):939-48. doi: 10.1080/10715760802555569.
PMID: 19031320BACKGROUNDBustamante V, Lopez de Santa Maria E, Gorostiza A, Jimenez U, Galdiz JB. Muscle training with repetitive magnetic stimulation of the quadriceps in severe COPD patients. Respir Med. 2010 Feb;104(2):237-45. doi: 10.1016/j.rmed.2009.10.001. Epub 2009 Nov 5.
PMID: 19896353BACKGROUNDBarreiro E, Peinado VI, Galdiz JB, Ferrer E, Marin-Corral J, Sanchez F, Gea J, Barbera JA; ENIGMA in COPD Project. Cigarette smoke-induced oxidative stress: A role in chronic obstructive pulmonary disease skeletal muscle dysfunction. Am J Respir Crit Care Med. 2010 Aug 15;182(4):477-88. doi: 10.1164/rccm.200908-1220OC. Epub 2010 Apr 22.
PMID: 20413628BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2010
First Posted
December 22, 2010
Study Start
January 1, 2011
Primary Completion
June 1, 2012
Study Completion
July 1, 2012
Last Updated
December 22, 2010
Record last verified: 2010-12