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

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01786928

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Other: Resistance training	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of Resistance Training During Hospitalization in COPD Patients: a Randomized and Controlled Trial

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: resistance training resistance training of the upper and lower limbs, two series of 80% of repetition maximum test	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.
No Intervention: Control Traditional Respiratory Therapy for bronchial hygiene

Arm

Intervention/Treatment

Experimental: resistance training

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

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.

No Intervention: Control

Traditional Respiratory Therapy for bronchial hygiene

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The benefits of resistance training during exacerbation of COPD on physical activity in daily life [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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