Evaluation of Utility Quadriceps Magnetic Stimulation in COPD (Chronic Obstructive Pulmonary Disease) Patients After Hospital Exacerbation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Hospital de Cruces.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Basurto hospital
Euskal Herriko Unibertsitatea. Universidad del Pais Vasco.
Osakidetza
Information provided by:
Hospital de Cruces
ClinicalTrials.gov Identifier:
NCT01264978
First received: December 21, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Hospital de Cruces:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:
  • MEDTRONIC Magpro MCF125
  • Refrigerated 60mm circular coil.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264978

Contacts
Contact: Victor Bustamante 0034617232750 victor.bustamantemadariaga@osakidetza.net
Contact: Juan B. Gáldiz, PhD 0034946006000 ext 2110 Juanbautista.galdiziturri@osakidetza.net

Locations
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         
Sponsors and Collaborators
Hospital de Cruces
Basurto hospital
Euskal Herriko Unibertsitatea. Universidad del Pais Vasco.
Osakidetza
  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:
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014