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Early Pulmonary Rehabilitation in Exacerbated COPD Patients

Early Pulmonary Rehabilitation With Elastic Resistance in Exacerbated COPD Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03131752
Enrollment
38
Registered
2017-04-27
Start date
2017-06-07
Completion date
2019-03-07
Last updated
2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease, muscle strength, physical activity

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.

Interventions

BEHAVIORALElastic 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.

Sponsors

Universidade Federal de Sao Carlos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Muscle Strength pre and post first contact24-48 hours after the start of exacerbation medication and 7 days after the first contactThe 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.
Muscle Strength Follow-up1 month after the first contactThe 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.
Muscle Strength Follow-up 23 months after the first contactThe 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.

Secondary

MeasureTime frameDescription
Physical activity level pre and post first contact24-48 hours after the start of exacerbation medication and 7 days after the first contactThe effect of intervention or no intervention on physical activity level will be evaluated by the actigraph (activPAL3TM - PAL Technologies Ltd., Glasgow, United Kingdom) through the number of steps, time spent in different positions during 7 days.
Physical activity level Follow-up1 month after the first contactThe benefits of intervention or no intervention on physical activity level will be evaluated by the actigraph (activPAL3TM - PAL Technologies Ltd., Glasgow, United Kingdom) through the number of steps, time spent in different positions during 7 days, 1 month after the first contact.
Physical activity level Follow-up 23 months after the first contactThe physical activity level 3 months after exacerbation will be evaluated by the actigraph (activPAL3TM - PAL Technologies Ltd., Glasgow, United Kingdom) through the number of steps, time spent in different positions during 7 days, 3 months after the first contact.

Countries

Brazil

Contacts

Primary ContactAnna Claudia Sentanin, Masters
annasentanin@gmail.com+55 (16)997328284
Backup ContactCarina de Araujo Facio, Graduated
cafacio@gmail.com+ 55 (17) 991039436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026