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The Role of Resistance Exercise in Chronic Obstructive Pulmonary Disease Exacerbation (RECOPD)

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ClinicalTrials.gov Identifier: NCT01786928
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : February 8, 2013
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Celso Ricardo Fernandes de Carvalho, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE January 10, 2012
First Posted Date  ICMJE February 8, 2013
Last Update Posted Date February 8, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization [ Time Frame: Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days) ]
The metric used to evaluate the strength gain is given in kilogram (absolute value) and percentage relative to that obtained on the second hospital day
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
The benefits of resistance training during exacerbation of COPD on physical activity in daily life [ Time Frame: Will be evaluated in the third and fifth day of hospitalization and thirty days after discharge ]
The metric used to evaluate the changes will be given in minutes and percentage of total time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Resistance Exercise in Chronic Obstructive Pulmonary Disease Exacerbation
Official Title  ICMJE Impact of Resistance Training During Hospitalization in COPD Patients: a Randomized and Controlled Trial
Brief Summary The purpose of this study is to determine whether resistance exercise are effective in combating the decline in muscle strength during an exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
Detailed Description

Acute exacerbations are common in patients with COPD and cause specific signs and symptoms, such as increased dyspnea, productive cough with altered sputum, and fever. With disease progression, exacerbations are frequent and have a negative impact on health related quality of life and pulmonary function as well as increase mortality. More severe exacerbations require hospitalization resulting in enormous health expenditures, severely reducing daily life activities and declining peripheral muscle strength that can be only partially reversed after 3 months. Despite many features have been pointed out as responsible for the decrease in muscle strength during hospitalization, physical inactivity seems the most important.

Resistance training is an interesting therapeutic option to prevent and/or reverse muscular dysfunction due to immobilised in healthy subjects and stable COPD patients because induces hypertrophy of type II fibers, increases muscle strength and exercise tolerance. In addition, provokes lower dyspnea perception during effort compared with other exercise training. Despite these benefits for stable COPD, the impact of a resistance exercise program during hospitalization remains poorly known.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Other: Resistance training
Resistance training group received training program for upper (shoulder flexion and abduction and biceps) and lower limbs (knee extension and flexion and hip flexion). Daily exercise for every muscle was performed with free weights at 80% of an maximal repetition test and a 4 minutes rest was allowed between each step.
Study Arms  ICMJE
  • Experimental: resistance training
    resistance training of the upper and lower limbs, two series of 80% of repetition maximum test
    Intervention: Other: Resistance training
  • No Intervention: Control
    Traditional Respiratory Therapy for bronchial hygiene
Publications * Borges RC, Carvalho CR. Impact of resistance training in chronic obstructive pulmonary disease patients during periods of acute exacerbation. Arch Phys Med Rehabil. 2014 Sep;95(9):1638-45. doi: 10.1016/j.apmr.2014.05.007. Epub 2014 May 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2013)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients hospitalized for exacerbation of COPD

Exclusion Criteria:

  • patients presenting change in mental status (confusion, lethargy or coma)
  • persistence or worsening in hypoxemia (PaO2<40mmHg) and/or respiratory acidosis (pH<7.25) despite oxygen supplementation or use of non-invasive ventilation
  • hemodynamic instability requiring vasoactive drugs
  • patients transferred to ICU
  • hospitalization lower than 5 days
  • diseases that prevented the exercises
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01786928
Other Study ID Numbers  ICMJE PTR-001-RCB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celso Ricardo Fernandes de Carvalho, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Study Chair: Rodrigo C Borges, specialist school of Medicine university of sao paulo
PRS Account University of Sao Paulo
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP