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

NCT ID: NCT01295359

Last Updated: 2011-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Trained Group

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

Group Type EXPERIMENTAL

Ground Walking Program

Intervention Type OTHER

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.

Usual Care Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Physical Therapy Respiratory Rehabilitation

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal de São Carlos

Principal Investigators

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Valéria Amorim Pires Di Lorenzo, PhD

Role: STUDY_DIRECTOR

Universidade Federal de Sao Carlos

Adriana Sanches Garcia de Araujo, Masters

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Sao Carlos

Juliano Ferreira Arcuri, Especialist

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Sao Carlos

Locations

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Hospital Escola Municipal "Dr Horácio Carlos Panepucci

São Carlos, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Juliano Ferreira Arcuri, Especialist

Role: CONTACT

+55 (16) 97838283

Adriana Sanches Garcia de Araujo, Masters

Role: CONTACT

+55 (16) 81587480

Facility Contacts

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Mariza Borges Brito de Souza, PhD

Role: primary

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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DPOCexacaminhada

Identifier Type: -

Identifier Source: org_study_id

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