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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Universidade Federal de Sao Carlos.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT01295359
First received: February 11, 2011
Last updated: March 18, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: Ground Walking Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of a Hospital Physical Therapy Program on Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • Change in Exercise Capacity [ Time Frame: Daily, as soon as medically appropriated, during the hospitalization ] [ Designated as safety issue: No ]
    It will be evaluated through the six minutes walking distance, performed according to ATS rules.

  • Change in BODE index [ Time Frame: Daily, as soon as medically appropriated, during the hospitalization ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily, as soon as medically appropriated, during the hospitalization ] [ Designated as safety issue: No ]
    Dyspnea during the six minutes walk test through the BORG CR10 scale

  • Change in Perceived discomfort in lower limbs [ Time Frame: Daily, as soon as medically appropriated, during the hospitalization ] [ Designated as safety issue: No ]
    Evaluated during the six minutes walk test through the BORG CR10 scale

  • Change in Variation in Heart Rate [ Time Frame: Daily, as soon as medically appropriated, during the hospitalization ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily, as soon as medically appropriated, during the hospitalization ] [ Designated as safety issue: No ]
    Will be evaluated the need of oxygen therapy during the six minutes walk test

  • Change in Handgrip Isometric Force [ Time Frame: Daily, as soon as medically appropriated, during the hospitalization ] [ Designated as safety issue: No ]
    It will be evaluated through a hand grip dynamometer.

  • Change in General Quality of Life [ Time Frame: first day of the protocol and at the day of discharge ] [ Designated as safety issue: No ]
    It will be evaluated through the SF-36 questionnaire

  • Change in Body Composition [ Time Frame: Daily, as soon as medically appropriated, during the hospitalization ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily, as soon as medically appropriated, during the hospitalization ] [ Designated as safety issue: No ]
    It will be evaluated through espirometry

  • Days in hospital [ Time Frame: At the discharge ] [ Designated as safety issue: No ]
  • Change in Reported Dyspnea [ Time Frame: Daily, as soon as medically appropriated, during the hospitalization ] [ Designated as safety issue: No ]
    It will be evaluated through the Modified Medical Research Concil Questionnaire

  • Change in Heart Rate Variability [ Time Frame: first day of the protocol and at the day of discharge ] [ Designated as safety issue: No ]
    It will be recorded through a cardiac monitor, and analized in the time and frequency domain, and non-linear analysis.

  • Quadriceps Isometric Force [ Time Frame: first day of the protocol and at the day of discharge ] [ Designated as safety issue: No ]
    It will be evaluated through a hand held dynamometer.


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295359

Contacts
Contact: Juliano Ferreira Arcuri, Especialist +55 (16) 97838283 julianoarcuri@gmail.com
Contact: Adriana Sanches Garcia de Araujo, Masters +55 (16) 81587480 garciadrica@hotmail.com

Locations
Brazil
Hospital Escola Municipal "Dr Horácio Carlos Panepucci Recruiting
São Carlos, São Paulo, Brazil, 13566-488
Contact: Mariza Borges Brito de Souza, PhD    33625555    souzamar@ufscar.br   
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         
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Study Director: Valéria Amorim Pires Di Lorenzo, PhD Universidade Federal de Sao Carlos
Principal Investigator: Adriana Sanches Garcia de Araujo, Masters Universidade Federal de Sao Carlos
Principal Investigator: Juliano Ferreira Arcuri, Especialist Universidade Federal de Sao Carlos
  More Information

Publications:

Responsible Party: Valéria Amorim Pires Di Lorenzo, Universidade Federal de São Carlos
ClinicalTrials.gov Identifier: NCT01295359     History of Changes
Other Study ID Numbers: DPOCexacaminhada
Study First Received: February 11, 2011
Last Updated: March 18, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Sao Carlos:
Chronic Obstructive Pulmonary Disease
Walking
Hospital
Exercise Tolerance
Physical Therapy

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014