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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01295359
• Other study ID #: DPOCexacaminhada
• Status: Recruiting
• Phase: N/A
• First received: February 11, 2011
• Last updated: March 18, 2011
• Start date: March 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2011
• Source: Universidade Federal de Sao Carlos
• Contact: Juliano Ferreira Arcuri, Especialist
• Phone: +55 (16) 97838283
• Email: julianoarcuri[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Escola Municipal "Dr Horácio Carlos Panepucci	São Carlos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

References & Publications (23)

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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. — View Citation

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. — View Citation

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

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. doi: 10.1097/CCM.0b013e3181a38937. — View Citation

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. — View Citation

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. doi: 10.1111/j.1440-1843.2008.01418.x. — View Citation

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. doi: 10.1097/MAJ.0b013e3181bb8111. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1513/pats.200905-027DS. Review. — View Citation

Mathers CD, Boerma T, Ma Fat D. Global and regional causes of death. Br Med Bull. 2009;92:7-32. doi: 10.1093/bmb/ldp028. Epub . Review. — View Citation

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. — View Citation

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. doi: 10.1016/j.rmed.2009.03.003. Epub 2009 Apr 5. — View Citation

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. — View Citation

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

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. — View Citation

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. doi: 10.1002/14651858.CD005305.pub2. Review. Update in: Cochrane Database Syst Rev. 2011;(10):CD005305. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Change in Perceived Dyspnea	Dyspnea during the six minutes walk test through the BORG CR10 scale	Daily, as soon as medically appropriated, during the hospitalization	No
Secondary	Change in Perceived discomfort in lower limbs	Evaluated during the six minutes walk test through the BORG CR10 scale	Daily, as soon as medically appropriated, during the hospitalization	No
Secondary	Change in Variation in Heart Rate	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	No
Secondary	Change in the need of oxygen therapy	Will be evaluated the need of oxygen therapy during the six minutes walk test	Daily, as soon as medically appropriated, during the hospitalization	No
Secondary	Change in Handgrip Isometric Force	It will be evaluated through a hand grip dynamometer.	Daily, as soon as medically appropriated, during the hospitalization	No
Secondary	Change in General Quality of Life	It will be evaluated through the SF-36 questionnaire	first day of the protocol and at the day of discharge	No
Secondary	Change in Body Composition	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	No
Secondary	Change in Forced Expiratory Volume in the First Second	It will be evaluated through espirometry	Daily, as soon as medically appropriated, during the hospitalization	No
Secondary	Days in hospital		At the discharge	No
Secondary	Change in Reported Dyspnea	It will be evaluated through the Modified Medical Research Concil Questionnaire	Daily, as soon as medically appropriated, during the hospitalization	No
Secondary	Change in Heart Rate Variability	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	No
Secondary	Quadriceps Isometric Force	It will be evaluated through a hand held dynamometer.	first day of the protocol and at the day of discharge	No