Early Pulmonary Rehabilitation in Exacerbated COPD Patients

NCT03131752 | Unknown

• 1 other identifier: ElastRes COPD 2016
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Keywords

chronic obstructive pulmonary disease; muscle strength; physical activity

Outcome Measures

Primary Outcomes (3)

• Muscle Strength pre and post first contact

  The effect of intervention or no intervention on muscle strength will be evaluated by the portable dynamometer (Microfet 2®, Hoggan - Health Industries, West Jordan, UT, USA). It will be positioned in front of the leg to assess quadriceps strength.

  24-48 hours after the start of exacerbation medication and 7 days after the first contact

• Muscle Strength Follow-up

  The benefits of intervention or no intervention on muscle strength will be evaluated by the portable dynamometer (Microfet 2®, Hoggan - Health Industries, West Jordan, UT, USA).It will be positioned in front of the leg to assess quadriceps strength 1 month after the first contact.

  1 month after the first contact

• Muscle Strength Follow-up 2

  The muscle strength 3 months after exacerbation will be evaluated by the portable dynamometer (Microfet 2®, Hoggan - Health Industries, West Jordan, UT, USA). It will be positioned in front of the leg to assess quadriceps strength 3 months after the first contact.

  3 months after the first contact

Secondary Outcomes (3)

• Physical activity level pre and post first contact

  24-48 hours after the start of exacerbation medication and 7 days after the first contact

• Physical activity level Follow-up

  1 month after the first contact

• Physical activity level Follow-up 2

  3 months after the first contact

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Elastic Resistance Intervention in Exacerbated Patients

Control Group

NO INTERVENTION

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.

Interventions

Elastic Resistance Intervention in Exacerbated Patients 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.

Also known as: GI

Intervention Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (1)

Special Respiratory Physiotherapy Unit of the Federal University of São Carlos

São Carlos, São Paulo, 13561-206, Brazil

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Valeria Di Lorenzo, PhD

  Universidade Federal de Sao Carlos

  STUDY DIRECTOR

Central Study Contacts

Anna Claudia Sentanin, Masters

CONTACT

+55 (16)997328284; annasentanin@gmail.com

Carina de Araujo Facio, Graduated

CONTACT

+ 55 (17) 991039436; cafacio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 27, 2017
• Study Start: June 7, 2017
• Primary Completion: August 7, 2017
• Study Completion: March 7, 2019
• Last Updated: April 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)