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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01786928
Other study ID # PTR-001-RCB
Secondary ID
Status Completed
Phase N/A
First received January 10, 2012
Last updated February 5, 2013
Start date April 2009
Est. completion date October 2010

Study information

Verified date February 2013
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date October 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil University Hospital of sao paulo São Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Will be evaluated on the second day of hospitalization, the day of hospital discharge (this time interval must be longer than five days) Yes
Secondary 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 Will be evaluated in the third and fifth day of hospitalization and thirty days after discharge Yes
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