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

NCT01295359 | Unknown

• 1 other identifier: DPOCexacaminhada
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Walking; Hospital; Exercise Tolerance; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• Change in Exercise Capacity

  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

  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 Outcomes (12)

• Change in Perceived Dyspnea

  Daily, as soon as medically appropriated, during the hospitalization

• Change in Perceived discomfort in lower limbs

  Daily, as soon as medically appropriated, during the hospitalization

• Change in Variation in Heart Rate

  Daily, as soon as medically appropriated, during the hospitalization

• Change in the need of oxygen therapy

  Daily, as soon as medically appropriated, during the hospitalization

• Change in Handgrip Isometric Force

  Daily, as soon as medically appropriated, during the hospitalization

Study Arms (2)

Trained Group

EXPERIMENTAL

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

Other: Ground Walking Program

Usual Care Group

NO INTERVENTION

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

Interventions

Ground Walking Program 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.

Also known as: Physical Therapy, Respiratory Rehabilitation

Trained Group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Hospital Escola Municipal "Dr Horácio Carlos Panepucci

São Carlos, São Paulo, 13566-488, Brazil

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Valéria Amorim Pires Di Lorenzo, PhD

  Universidade Federal de Sao Carlos

  STUDY DIRECTOR

• Adriana Sanches Garcia de Araujo, Masters

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

• Juliano Ferreira Arcuri, Especialist

  Universidade Federal de Sao Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliano Ferreira Arcuri, Especialist

CONTACT

+55 (16) 97838283; julianoarcuri@gmail.com

Adriana Sanches Garcia de Araujo, Masters

CONTACT

+55 (16) 81587480; garciadrica@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 14, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 21, 2011

Record last verified: 2011-02

Locations

BR (1)