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Impact of a Hospital Physical Therapy Program on Chronic Obstructive Pulmonary Disease (COPD) Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ground Walking Program
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, Walking, Hospital, Exercise Tolerance, Physical Therapy

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COPD Patients (FEV1/FVC < 0,70; FEV1 > 30% and < 80%)
  • Hospitalized for exacerbation of COPD

Exclusion Criteria:

  • Conditions that could restrict walking

    • Skeletal-muscle and joint disturbs
    • Extreme Obesity (BMI > 35kg/m²)
  • Heart Failure (New York Heart Association class III and IV)
  • Uncontrolled infection (fever > 38ºC and leukocytosis > 10000 cels/dl)
  • Need of Invasive Mechanical Ventilation after the beginning of the program
  • Previous Diagnosis of:

    • Stroke
    • Epilepsy
  • Coagulation disorders (INR > 1,5 or platelets < 50.000/m³)
  • Psychiatric Disorders or severe agitation
  • Cardiac or respiratory instability
  • Oxygen therapy > 3L/min at rest
  • Respiratory Rate > 30 breaths/min at rest
  • Tachycardia and Bradycardia
  • Vasoactive Drugs need

Sites / Locations

  • Hospital Escola Municipal "Dr Horácio Carlos PanepucciRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Trained Group

Usual Care Group

Arm Description

This group will receive the usual care of the hospital and a ground walking training program associated with respiratory exercises.

This group will only receive the usual care of the hospital, including physical therapy

Outcomes

Primary Outcome Measures

Change in Exercise Capacity
It will be evaluated through the six minutes walking distance, performed according to ATS rules.
Change in BODE index
The Body-Mass Index, Airways Obstruction, Dyspnea, Exercise Capacity (BODE) index. This is a multidimensional evaluation that includes Forced Expiratory Volume in the first second, Body-Mass Index, 6 Minutes Walking Distance and mMRC score. It is an index to predict mortality.

Secondary Outcome Measures

Change in Perceived Dyspnea
Dyspnea during the six minutes walk test through the BORG CR10 scale
Change in Perceived discomfort in lower limbs
Evaluated during the six minutes walk test through the BORG CR10 scale
Change in Variation in Heart Rate
It will be evaluated the variation in the Heart Rate during the six minutes walk test (Exercise Peak - rest)
Change in the need of oxygen therapy
Will be evaluated the need of oxygen therapy during the six minutes walk test
Change in Handgrip Isometric Force
It will be evaluated through a hand grip dynamometer.
Change in General Quality of Life
It will be evaluated through the SF-36 questionnaire
Change in Body Composition
It will be performed through a body composition monitor, evaluating weight, body Fat percentage, Muscle Mass, Basal Metabolic Rate, Bone Mass and Total Body Water Percentage.
Change in Forced Expiratory Volume in the First Second
It will be evaluated through espirometry
Days in hospital
Change in Reported Dyspnea
It will be evaluated through the Modified Medical Research Concil Questionnaire
Change in Heart Rate Variability
It will be recorded through a cardiac monitor, and analized in the time and frequency domain, and non-linear analysis.
Quadriceps Isometric Force
It will be evaluated through a hand held dynamometer.

Full Information

First Posted
February 11, 2011
Last Updated
March 18, 2011
Sponsor
Universidade Federal de Sao Carlos
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT01295359
Brief Title
Impact of a Hospital Physical Therapy Program on Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Impact of a Hospital Physical Therapy Program on Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Chronic Obstructive Pulmonary Disease is a leading global cause of morbidity and mortality, so it's important to find actions that could improve quality of life and decrease the mortality. The objective of this study is to verify if a ground walking program applied to hospitalized exacerbated COPD patients has effects in quality of life, exercise capacity, airways obstruction, body composition, heart rate variability, quadriceps isometric force and in the "Body-mass index, Airway Obstruction, Dyspnea, Exercise Capacity index" (BODE index). An evaluators-blinded randomized controlled study will be conducted in "Hospital Escola Municipal de São Carlos" where forty patients will be recruited to participate. The volunteers will be randomized in two groups with twenty patients, the usual care group, that will receive only the usual care of the hospital; and the trained group that will receive the same care, but will also participate in a ground walking program associated with respiratory exercises. It will be evaluated, in the start and at the end of the program, the health related and general quality of life and the Barthel index. Daily, the patient will be submitted to the Six Minute Walk Test, to a body composition analysis, to a hand grip test and to a dyspnea assessment, and will be calculated its BODE index. All patients will be invited to a follow up in the 12th and 24th weeks after hospital discharge, when they would receive the same evaluation of the last day in the hospital. All the collected data will be expressed in means and standard deviations or medians and range when appropriated. It will be chosen appropriated tests to compare and correlate them.

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, Walking, Hospital, Exercise Tolerance, Physical Therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Trained Group
Arm Type
Experimental
Arm Description
This group will receive the usual care of the hospital and a ground walking training program associated with respiratory exercises.
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
This group will only receive the usual care of the hospital, including physical therapy
Intervention Type
Other
Intervention Name(s)
Ground Walking Program
Other Intervention Name(s)
Physical Therapy, Respiratory Rehabilitation
Intervention Description
The patients will walk on a corridor, for 40min, once a day. The speed will be controlled through a metronome, that will be programed to a frequency of steps/min determinated as 80% of the mean frequency of steps performed in six minutes walk test of that day. The 40min will be divided in 3min of walk and 2min of rest, totalizing 24min of exercise and 16min of rest. Furthermore, these patients, in sitting position, will receive orientation to do calm and slow inspirations and expirations, associated with pursed lips expiration. They will try to maintain its Respiratory Rate in 6bpm, during four minutes.
Primary Outcome Measure Information:
Title
Change in Exercise Capacity
Description
It will be evaluated through the six minutes walking distance, performed according to ATS rules.
Time Frame
Daily, as soon as medically appropriated, during the hospitalization
Title
Change in BODE index
Description
The Body-Mass Index, Airways Obstruction, Dyspnea, Exercise Capacity (BODE) index. This is a multidimensional evaluation that includes Forced Expiratory Volume in the first second, Body-Mass Index, 6 Minutes Walking Distance and mMRC score. It is an index to predict mortality.
Time Frame
Daily, as soon as medically appropriated, during the hospitalization
Secondary Outcome Measure Information:
Title
Change in Perceived Dyspnea
Description
Dyspnea during the six minutes walk test through the BORG CR10 scale
Time Frame
Daily, as soon as medically appropriated, during the hospitalization
Title
Change in Perceived discomfort in lower limbs
Description
Evaluated during the six minutes walk test through the BORG CR10 scale
Time Frame
Daily, as soon as medically appropriated, during the hospitalization
Title
Change in Variation in Heart Rate
Description
It will be evaluated the variation in the Heart Rate during the six minutes walk test (Exercise Peak - rest)
Time Frame
Daily, as soon as medically appropriated, during the hospitalization
Title
Change in the need of oxygen therapy
Description
Will be evaluated the need of oxygen therapy during the six minutes walk test
Time Frame
Daily, as soon as medically appropriated, during the hospitalization
Title
Change in Handgrip Isometric Force
Description
It will be evaluated through a hand grip dynamometer.
Time Frame
Daily, as soon as medically appropriated, during the hospitalization
Title
Change in General Quality of Life
Description
It will be evaluated through the SF-36 questionnaire
Time Frame
first day of the protocol and at the day of discharge
Title
Change in Body Composition
Description
It will be performed through a body composition monitor, evaluating weight, body Fat percentage, Muscle Mass, Basal Metabolic Rate, Bone Mass and Total Body Water Percentage.
Time Frame
Daily, as soon as medically appropriated, during the hospitalization
Title
Change in Forced Expiratory Volume in the First Second
Description
It will be evaluated through espirometry
Time Frame
Daily, as soon as medically appropriated, during the hospitalization
Title
Days in hospital
Time Frame
At the discharge
Title
Change in Reported Dyspnea
Description
It will be evaluated through the Modified Medical Research Concil Questionnaire
Time Frame
Daily, as soon as medically appropriated, during the hospitalization
Title
Change in Heart Rate Variability
Description
It will be recorded through a cardiac monitor, and analized in the time and frequency domain, and non-linear analysis.
Time Frame
first day of the protocol and at the day of discharge
Title
Quadriceps Isometric Force
Description
It will be evaluated through a hand held dynamometer.
Time Frame
first day of the protocol and at the day of discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD Patients (FEV1/FVC < 0,70; FEV1 > 30% and < 80%) Hospitalized for exacerbation of COPD Exclusion Criteria: Conditions that could restrict walking Skeletal-muscle and joint disturbs Extreme Obesity (BMI > 35kg/m²) Heart Failure (New York Heart Association class III and IV) Uncontrolled infection (fever > 38ºC and leukocytosis > 10000 cels/dl) Need of Invasive Mechanical Ventilation after the beginning of the program Previous Diagnosis of: Stroke Epilepsy Coagulation disorders (INR > 1,5 or platelets < 50.000/m³) Psychiatric Disorders or severe agitation Cardiac or respiratory instability Oxygen therapy > 3L/min at rest Respiratory Rate > 30 breaths/min at rest Tachycardia and Bradycardia Vasoactive Drugs need
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliano Ferreira Arcuri, Especialist
Phone
+55 (16) 97838283
Email
julianoarcuri@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Sanches Garcia de Araujo, Masters
Phone
+55 (16) 81587480
Email
garciadrica@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valéria Amorim Pires Di Lorenzo, PhD
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Adriana Sanches Garcia de Araujo, Masters
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juliano Ferreira Arcuri, Especialist
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Escola Municipal "Dr Horácio Carlos Panepucci
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13566-488
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariza Borges Brito de Souza, PhD
Phone
33625555
Email
souzamar@ufscar.br
First Name & Middle Initial & Last Name & Degree
Juliano Ferreira Arcuri, Especialist
First Name & Middle Initial & Last Name & Degree
Adriana Sanches Garcia de Araujo, Masters
First Name & Middle Initial & Last Name & Degree
Valéria Amorim Pires Di Lorenzo, PhD
First Name & Middle Initial & Last Name & Degree
Bruna Varanda Pessoa, Masters
First Name & Middle Initial & Last Name & Degree
Julia Gianjoppe dos Santos, Especialist
First Name & Middle Initial & Last Name & Degree
Audrey Borghi-Silva, PhD

12. IPD Sharing Statement

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Impact of a Hospital Physical Therapy Program on Chronic Obstructive Pulmonary Disease (COPD) Patients

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