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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance training
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, exacerbation, resistance training, muscle force

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of sao paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

resistance training

Control

Arm Description

resistance training of the upper and lower limbs, two series of 80% of repetition maximum test

Traditional Respiratory Therapy for bronchial hygiene

Outcomes

Primary Outcome Measures

The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization
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

Secondary Outcome Measures

The benefits of resistance training during exacerbation of COPD on physical activity in daily life
The metric used to evaluate the changes will be given in minutes and percentage of total time

Full Information

First Posted
January 10, 2012
Last Updated
February 5, 2013
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01786928
Brief Title
The Role of Resistance Exercise in Chronic Obstructive Pulmonary Disease Exacerbation
Acronym
RECOPD
Official Title
Impact of Resistance Training During Hospitalization in COPD Patients: a Randomized and Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
chronic obstructive pulmonary disease, exacerbation, resistance training, muscle force

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
resistance training
Arm Type
Experimental
Arm Description
resistance training of the upper and lower limbs, two series of 80% of repetition maximum test
Arm Title
Control
Arm Type
No Intervention
Arm Description
Traditional Respiratory Therapy for bronchial hygiene
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
The benefits of resistance training during exacerbation of COPD on peripheral muscle strength during hospitalization
Description
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
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)
Secondary Outcome Measure Information:
Title
The benefits of resistance training during exacerbation of COPD on physical activity in daily life
Description
The metric used to evaluate the changes will be given in minutes and percentage of total time
Time Frame
Will be evaluated in the third and fifth day of hospitalization and thirty days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo C Borges, specialist
Organizational Affiliation
school of Medicine university of sao paulo
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of sao paulo
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24879965
Citation
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.
Results Reference
derived

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The Role of Resistance Exercise in Chronic Obstructive Pulmonary Disease Exacerbation

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