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

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:

MedlinePlus related topics: Breathing Problems COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness

U.S. FDA Resources

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

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

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:

Anderson D, Macnee W. Targeted treatment in COPD: a multi-system approach for a multi-system disease. Int J Chron Obstruct Pulmon Dis. 2009;4:321-35. Epub 2009 Sep 1. Review.

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. No abstract available.

Behnke M, Taube C, Kirsten D, Lehnigk B, Jörres RA, Magnussen H. Home-based exercise is capable of preserving hospital-based improvements in severe chronic obstructive pulmonary disease. Respir Med. 2000 Dec;94(12):1184-91.

Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505.

Burge S, Wedzicha JA. COPD exacerbations: definitions and classifications. Eur Respir J Suppl. 2003 Jun;41:46s-53s. Review.

Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12.

Eaton T, Young P, Fergusson W, Moodie L, Zeng I, O'Kane F, Good N, Rhodes L, Poole P, Kolbe J. Does early pulmonary rehabilitation reduce acute health-care utilization in COPD patients admitted with an exacerbation? A randomized controlled study. Respirology. 2009 Mar;14(2):230-8.

Faganello MM, Tanni SE, Sanchez FF, Pelegrino NR, Lucheta PA, Godoy I. BODE index and GOLD staging as predictors of 1-year exacerbation risk in chronic obstructive pulmonary disease. Am J Med Sci. 2010 Jan;339(1):10-4.

Gerardi DA, Lovett L, Benoit-Connors ML, Reardon JZ, ZuWallack RL. Variables related to increased mortality following out-patient pulmonary rehabilitation. Eur Respir J. 1996 Mar;9(3):431-5.

Kovelis D, Segretti NO, Probst VS, Lareau SC, Brunetto AF, Pitta F. Validation of the Modified Pulmonary Functional Status and Dyspnea Questionnaire and the Medical Research Council scale for use in Brazilian patients with chronic obstructive pulmonary disease. J Bras Pneumol. 2008 Dec;34(12):1008-18. English, Portuguese.

Iucif N Jr, Rocha JS. [Study of inequalities in hospital mortality using the Charlson comorbidity index]. Rev Saude Publica. 2004 Dec;38(6):780-6. Epub 2004 Dec 10. Portuguese.

MacNee W, Tuder RM. New paradigms in the pathogenesis of chronic obstructive pulmonary disease I. Proc Am Thorac Soc. 2009 Sep 15;6(6):527-31. Review.

Mathers CD, Boerma T, Ma Fat D. Global and regional causes of death. Br Med Bull. 2009;92:7-32. Review.

Nasis IG, Vogiatzis I, Stratakos G, Athanasopoulos D, Koutsoukou A, Daskalakis A, Spetsioti S, Evangelodimou A, Roussos C, Zakynthinos S. Effects of interval-load versus constant-load training on the BODE index in COPD patients. Respir Med. 2009 Sep;103(9):1392-8. Epub 2009 Apr 5.

Murphy N, Bell C, Costello RW. Extending a home from hospital care programme for COPD exacerbations to include pulmonary rehabilitation. Respir Med. 2005 Oct;99(10):1297-302. Epub 2005 Mar 31.

Ong KC, Earnest A, Lu SJ. A multidimensional grading system (BODE index) as predictor of hospitalization for COPD. Chest. 2005 Dec;128(6):3810-6.

Oxford KL. Elbow positioning for maximum grip performance. J Hand Ther. 2000 Jan-Mar;13(1):33-6.

Pinto-Plata VM, Cote C, Cabral H, Taylor J, Celli BR. The 6-min walk distance: change over time and value as a predictor of survival in severe COPD. Eur Respir J. 2004 Jan;23(1):28-33.

Puhan M, Scharplatz M, Troosters T, Walters EH, Steurer J. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD005305. Review.

Seemungal TA, Hurst JR, Wedzicha JA. Exacerbation rate, health status and mortality in COPD--a review of potential interventions. Int J Chron Obstruct Pulmon Dis. 2009;4:203-23. Epub 2009 Jun 11. Review.

Urbano FL, Pascual RM. Contemporary issues in the care of patients with chronic obstructive pulmonary disease. J Manag Care Pharm. 2005 Jun;11(5 Suppl A):S2-13; quiz S14-6. Review.

Vogiatzis I, Nanas S, Roussos C. Interval training as an alternative modality to continuous exercise in patients with COPD. Eur Respir J. 2002 Jul;20(1):12-9.

Vogiatzis I, Terzis G, Nanas S, Stratakos G, Simoes DC, Georgiadou O, Zakynthinos S, Roussos C. Skeletal muscle adaptations to interval training in patients with advanced COPD. Chest. 2005 Dec;128(6):3838-45.

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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013