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

March 18, 2011 updated by: Universidade Federal de Sao Carlos

Impact of a Hospital Physical Therapy Program on Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 13566-488
        • Recruiting
        • Hospital Escola Municipal "Dr Horácio Carlos Panepucci
        • Contact:
        • Principal Investigator:
          • Juliano Ferreira Arcuri, Especialist
        • Principal Investigator:
          • Adriana Sanches Garcia de Araujo, Masters
        • Principal Investigator:
          • Valéria Amorim Pires Di Lorenzo, PhD
        • Sub-Investigator:
          • Bruna Varanda Pessoa, Masters
        • Sub-Investigator:
          • Julia Gianjoppe dos Santos, Especialist
        • Sub-Investigator:
          • Audrey Borghi-Silva, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Trained Group
This group will receive the usual care of the hospital and a ground walking training program associated with respiratory exercises.
Other: Ground Walking Program
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.
Other Names:
  • Physical Therapy
  • Respiratory Rehabilitation
No Intervention: Usual Care Group
This group will only receive the usual care of the hospital, including physical therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Exercise Capacity
Time Frame: Daily, as soon as medically appropriated, during the hospitalization
It will be evaluated through the six minutes walking distance, performed according to ATS rules.
Daily, as soon as medically appropriated, during the hospitalization
Change in BODE index
Time Frame: Daily, as soon as medically appropriated, during the hospitalization
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.
Daily, as soon as medically appropriated, during the hospitalization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Perceived Dyspnea
Time Frame: Daily, as soon as medically appropriated, during the hospitalization
Dyspnea during the six minutes walk test through the BORG CR10 scale
Daily, as soon as medically appropriated, during the hospitalization
Change in Perceived discomfort in lower limbs
Time Frame: Daily, as soon as medically appropriated, during the hospitalization
Evaluated during the six minutes walk test through the BORG CR10 scale
Daily, as soon as medically appropriated, during the hospitalization
Change in Variation in Heart Rate
Time Frame: Daily, as soon as medically appropriated, during the hospitalization
It will be evaluated the variation in the Heart Rate during the six minutes walk test (Exercise Peak - rest)
Daily, as soon as medically appropriated, during the hospitalization
Change in the need of oxygen therapy
Time Frame: Daily, as soon as medically appropriated, during the hospitalization
Will be evaluated the need of oxygen therapy during the six minutes walk test
Daily, as soon as medically appropriated, during the hospitalization
Change in Handgrip Isometric Force
Time Frame: Daily, as soon as medically appropriated, during the hospitalization
It will be evaluated through a hand grip dynamometer.
Daily, as soon as medically appropriated, during the hospitalization
Change in General Quality of Life
Time Frame: first day of the protocol and at the day of discharge
It will be evaluated through the SF-36 questionnaire
first day of the protocol and at the day of discharge
Change in Body Composition
Time Frame: Daily, as soon as medically appropriated, during the hospitalization
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.
Daily, as soon as medically appropriated, during the hospitalization
Change in Forced Expiratory Volume in the First Second
Time Frame: Daily, as soon as medically appropriated, during the hospitalization
It will be evaluated through espirometry
Daily, as soon as medically appropriated, during the hospitalization
Days in hospital
Time Frame: At the discharge
At the discharge
Change in Reported Dyspnea
Time Frame: Daily, as soon as medically appropriated, during the hospitalization
It will be evaluated through the Modified Medical Research Concil Questionnaire
Daily, as soon as medically appropriated, during the hospitalization
Change in Heart Rate Variability
Time Frame: first day of the protocol and at the day of discharge
It will be recorded through a cardiac monitor, and analized in the time and frequency domain, and non-linear analysis.
first day of the protocol and at the day of discharge
Quadriceps Isometric Force
Time Frame: first day of the protocol and at the day of discharge
It will be evaluated through a hand held dynamometer.
first day of the protocol and at the day of discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Sao Carlos

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Valéria Amorim Pires Di Lorenzo, PhD, Universidade Federal de São Carlos
  • Principal Investigator: Adriana Sanches Garcia de Araujo, Masters, Universidade Federal de São Carlos
  • Principal Investigator: Juliano Ferreira Arcuri, Especialist, Universidade Federal de São Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DPOCexacaminhada

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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