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Early Pulmonary Rehabilitation in Exacerbated COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Elastic Resistance Intervention in Exacerbated Patients
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, muscle strength, physical activity

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Special Respiratory Physiotherapy Unit of the Federal University of São CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Physical activity level pre and post first contact
The 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-up
The 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 2
The 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.

Full Information

First Posted
March 30, 2017
Last Updated
April 24, 2017
Sponsor
Universidade Federal de Sao Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT03131752
Brief Title
Early Pulmonary Rehabilitation in Exacerbated COPD Patients
Official Title
Early Pulmonary Rehabilitation With Elastic Resistance in Exacerbated COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 7, 2017 (Anticipated)
Primary Completion Date
August 7, 2017 (Anticipated)
Study Completion Date
March 7, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
chronic obstructive pulmonary disease, muscle strength, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Elastic Resistance Intervention in Exacerbated Patients
Other Intervention Name(s)
GI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle Strength pre and post first contact
Description
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.
Time Frame
24-48 hours after the start of exacerbation medication and 7 days after the first contact
Title
Muscle Strength Follow-up
Description
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.
Time Frame
1 month after the first contact
Title
Muscle Strength Follow-up 2
Description
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.
Time Frame
3 months after the first contact
Secondary Outcome Measure Information:
Title
Physical activity level pre and post first contact
Description
The 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.
Time Frame
24-48 hours after the start of exacerbation medication and 7 days after the first contact
Title
Physical activity level Follow-up
Description
The 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.
Time Frame
1 month after the first contact
Title
Physical activity level Follow-up 2
Description
The 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.
Time Frame
3 months after the first contact

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Claudia Sentanin, Masters
Phone
+55 (16)997328284
Email
annasentanin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carina de Araujo Facio, Graduated
Phone
+ 55 (17) 991039436
Email
cafacio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valeria Di Lorenzo, PhD
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Study Director
Facility Information:
Facility Name
Special Respiratory Physiotherapy Unit of the Federal University of São Carlos
City
Sao Carlos
State/Province
São Paulo
ZIP/Postal Code
13561-206
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valeria Di Lorenzo, PhD
Phone
+55 (16) 33518343
Email
vallorenzo@ufscar.br
First Name & Middle Initial & Last Name & Degree
Anna Claudia Sentanin, Ms
First Name & Middle Initial & Last Name & Degree
Carina de Araujo Facio, Graduated

12. IPD Sharing Statement

Plan to Share IPD
No
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Early Pulmonary Rehabilitation in Exacerbated COPD Patients

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