Early Pulmonary Rehabilitation in Exacerbated COPD Patients

NCT ID: NCT03131752

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-07
• Study Completion Date: 2019-03-07

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is characterized by chronic and progressive airflow limitations and subjects with COPD also experience exacerbations characterized by the worsening of respiratory symptoms. It's necessary medical intervention, changes in regular medication, and the use of antibiotics and/or corticosteroids followed or not by hospitalization. The exacerbations contribute to worsening of the disease with systemic impairment and muscle weakness is a very relevant event. The physical inactivity, especially related to bed rest, comprises one of the factors contributing to muscle atrophy and loss of muscle strength. Thus, the intervention performed during hospitalization is necessary to minimize the consequences which causes impairment in health status subjects. The aim of the study is assess the effect of the intervention with elastic bands, in muscle strength,level of the physical activity, functional capacity, dyspnea on activities of daily living (ADL) and quality of life in COPD exacerbation subjects. Moreover,verify the intervention benefits over 01 and 03 months post exacerbation episode. It will be a prospective, randomized, longitudinal and interventional study. The investigators will be asses both gender patients with exacerbation of COPD in 4 situations: First time (at least 24 and at most 48 hours after the beginning of medical therapy); seven days post the first assessment; one and three months post exacerbation episode. It will be assess the muscle strength, physical activity level, functional capacity, dyspnea on ADL and quality of life. The patients will be randomized in 2 groups: intervention and control group. The intervention will be performed with elastic bands once a day during seven days. The investigators expected that patients of the intervention group will present better muscle strength, physical activity level and functional capacity than the control group. Furthermore, an improvement in dyspnea and quality of life is expected in intervention group when compared as with control group patients. It is hypothesized that the benefits of intervention will be maintained over one month.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

The patients will be evaluated on 4 phases: at the first contact (at least 24 hours after drug therapy and at most 48 hours), 7 days, 30 days and 3 months after the first contact. They will be submitted to an anamnesis, assessment of muscular strength, physical activity level, functional capacity, dyspnea on activity daily living and quality of life.

The intervention will last 7 days for all the patients. Three phases will be performed: warm up, knee muscle strengthening with elastic bands and stretch/relax.

Group Type: EXPERIMENTAL

Elastic Resistance Intervention in Exacerbated Patients

Intervention Type: BEHAVIORAL

The intervention protocol will performed during 7 days for all patients and this will begin 24 -48 hours after the start of medication for exacerbation. Those who are hospitalized and discharged before this period will continue their treatment at the Laboratory of Spirometry and Respiratory Physiotherapy (LEFIR) of the Federal University of São Carlos. The intervention will also perform for at least 5 continuous days. The ideal elastic band for the training will be chosen through the test of 10 maximum repetitions. The test and the training will be performed in an ergonomic chair allowing the lower limbs to remain pending. After 24 hours of the test, patients will perform knee extension exercise with the appropriate elastic band. Three sets of 10 repetitions will be done in each exercise, with a minimum rest interval of 1 minute between sets or until heart rate values return to baseline. Patients will be re-evaluated 1 and 3 months after the first contact.

Control Group

The patients will be evaluated on 4 phases: at the first contact (at least 24 hours after drug therapy and at most 48 hours), 7 days, 30 days and 3 months after the first contact. They will be submitted to an anamnesis, assessment of muscular strength, physical activity level, functional capacity, dyspnea on activity daily living and quality of life.

Patients will be not receive intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Elastic Resistance Intervention in Exacerbated Patients

The intervention protocol will performed during 7 days for all patients and this will begin 24 -48 hours after the start of medication for exacerbation. Those who are hospitalized and discharged before this period will continue their treatment at the Laboratory of Spirometry and Respiratory Physiotherapy (LEFIR) of the Federal University of São Carlos. The intervention will also perform for at least 5 continuous days. The ideal elastic band for the training will be chosen through the test of 10 maximum repetitions. The test and the training will be performed in an ergonomic chair allowing the lower limbs to remain pending. After 24 hours of the test, patients will perform knee extension exercise with the appropriate elastic band. Three sets of 10 repetitions will be done in each exercise, with a minimum rest interval of 1 minute between sets or until heart rate values return to baseline. Patients will be re-evaluated 1 and 3 months after the first contact.

Intervention Type: BEHAVIORAL

Other Intervention Names

GI

Eligibility Criteria

Inclusion Criteria

• Patients aged 40 years or more, of both genders, who are in a an exacerbation of the disease according to Global Initiative for Chronic Obstructive Lung Disease (GOLD,2015) refered by the doctors, hospitalized or not in exacerbation treatment .All patients should be in spontaneous breathing at the time of assessment, in oxygen use or not and in conditions to understand the proposed evaluations; Patients who use non-invasive ventilation will also be included as long as it does not interfere with the protocols; All should agree to participate in the research in a free and informed manner. Patients who are referred to the Intensive Care Unit (ICU) may be included 24 hours after discharge from the ICU.

Exclusion Criteria

• Patients who present with orthopedic limitations, other pulmonary diseases, rheumatological, cardiovascular or neurological disorders that not allow the assessment. Patients whit drug os alcohol dependence, patients undergoing invasive mechanical ventilation, hemodynamic instability, the presence of unstable angina, will be excluded. In addition, patients with cognitive deficits that impair comprehension of the assessments will be excluded.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Valeria Amorim Pires Di Lorenzo

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valeria Di Lorenzo, PhD

Role: STUDY_DIRECTOR

Universidade Federal de Sao Carlos

Locations

Special Respiratory Physiotherapy Unit of the Federal University of São Carlos

São Carlos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Anna Claudia Sentanin, Masters

Role: CONTACT

annasentanin@gmail.com

+55 (16)997328284

Carina de Araujo Facio, Graduated

Role: CONTACT

cafacio@gmail.com

+ 55 (17) 991039436

Facility Contacts

Valeria Di Lorenzo, PhD

Role: primary

vallorenzo@ufscar.br

+55 (16) 33518343

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Other Identifiers

ElastRes COPD 2016

Identifier Type: -

Identifier Source: org_study_id