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Pulmonary Rehabilitation in Functional Outcomes and Its Relationship With Morbidity and Mortality in Patients With COPD

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ClinicalTrials.gov Identifier: NCT03692793
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dra. Anamaria Fleig Mayer, University of the State of Santa Catarina

Brief Summary:

Background: The pulmonary rehabilitation effects on various outcomes of COPD are well known. However, they may be lost over time due to poor adherence to therapy with absence of regular exercise maintenance in long term, disease progression, comorbidities, falls incidence and higher exacerbations frequency. Currently, the main focus is to make the patient more active and ensure the benefits maintenance. However, few studies have been concerned with the aim of to investigate the long-term effect of this intervention and the relationship of the change promoted in important outcomes of the disease with its morbidity and mortality.

Design: Non-controlled clinical trial, prospective and longitudinal. Setting: Outpatient pulmonary rehabilitation program in Florianopolis, Brazil

Subjects: Patients with COPD (GOLD II-IV).

Interventions: Pulmonary rehabilitation program (PRP) based on physical training, conducted over 24 sessions supervised, three times a week, including aerobic training in treadmill and resistance training for upper and lower limbs.

Main measures: Before, post-PRP, 6 months post-PRP and 12 months post-PRP will be measured Spirometry or Total Body Plethysmography, Triaxial Accelerometry by Dynaport Activity Monitor, Glittre ADL-Test to evaluated functional capacity and functional performance, Six-Minute Walk Test distance on tracks of 20 and 30 meters, muscle oxygenation variables by NIRS PortaLite®, force platform NeuroCom® SMART Equitest®, Timed Up and Go Test, Berg Balance Scale, Activities-specific Balance Confidence, Falls Efficacy Scale - International - Brasil, London Chest Activity of Daily Living score, Modified Medical Research Council score, Saint George Respiratory Questionnaire score, COPD Assessment Test score and Hospital Anxiety and Depression Scale, Behavioural Regulation in Exercise Questionnaire-2, Basic Psychological Needs in Exercise Scale, General self-efficacy scale, COPD self-efficacy scale, Pulmonary Rehabilitation Adapted Index of Self-Efficacy. The death cases and numbers of exacerbations and hospitalizations will be measured by monthly phone calls after PRP.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Other: Pulmonary rehabilitation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short, Medium and Long-term Effects of Pulmonary Rehabilitation in Dyspnea, Health Status, Anxiety and Depression Symptoms, Functional Status and Postural Control and Its Relationship With Morbimortality in Patients With COPD
Actual Study Start Date : April 1, 2013
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pulmonary rehabilitation
The PRP (24-session, three times for week) will be delivered according to ATS/ERS (Spruit et al, 2013),
Other: Pulmonary rehabilitation
Patients will perform continuous aerobic training (treadmill walking) during 30min (60% of the 6MWT mean speed) and progression according to dyspnea (4-6 of the modified Borg scale). Upper limbs resistance training will be performed using the modified diagonals from the proprioceptive neuromuscular facilitation method (2 sets of 2min). Lower limbs strength training will be performed for quadriceps and triceps sural (2 sets of 10 repetitions), with progression when the patients report that the exercise are ´easy´. All the muscle exercised and the breathing accessory muscles will be stretched for 30s. Eleven educational sessions will be delivered addressing topics related to COPD self-management.




Primary Outcome Measures :
  1. Physical activity in daily life [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in physical activity in daily life monitoring by accelerometry

  2. Morbidity [ Time Frame: Every month after the PRP up to 24 months ]
    Relationship of changes in outcomes with exacerbation, hospitalization and death

  3. Mortality [ Time Frame: Every month after the PRP up to 24 months ]
    Relationship of changes in outcomes with death


Secondary Outcome Measures :
  1. Dyspnea [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    modified Medical Research Council (mMRC) scale. The scale range is from 0 to 5, being that higher values correspond to worse dyspnea

  2. Health status - COPD Assessment Test (CAT) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    The CAT questionnaire range is from 0 to 40 points (8 items that range from 0 to 5 points each), being that higher values correspond to worse health status

  3. Health status - Saint George Respiratory questionnaire (SGRQ) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    The SGRQ range is from 0 to 100% (total and three domains: symptoms, activity and impact), being that higher values correspond to worse quality of life

  4. Anxiety and depression symptoms - Hospital Anxiety and Depression Scale (HADS) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    The HADS range is from 0 to 42 points (two domains: anxiety and depression - 21 points each), being that higher values correspond to more symptoms

  5. Functional status - Glittre-ADL Test (TGlittre) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in TGlittre

  6. Functional status - Six-Minute Walk Test (6MWT) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in 6MWT

  7. Functional status - London Chest Activity of Daily Living (LCADL) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in LCADL. The total score of LCADL (LCADLtotal) range is from 0 to 75 points and the percentage of total score of LCADL (LCADL%total) is calculated by excluding the questions answered zero. As higher the LCADLtotal and LCADL%total scores, worse the functional status

  8. Postural balance - force platform NeuroCom (COP) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change center of pressure (COP) displacement

  9. Postural balance - force platform NeuroCom (COG) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in center of gravity (COG) displacement

  10. Postural balance -Timed Up and Go (TUG) Test [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in TUG Test

  11. Postural balance - Berg Balance Scale (BBS) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in BBS. The scale presents 14 tasks, being that the score range is from 0 to 56 points (from 0 to 4 for each task). As lower the score, worse the postural control

  12. Postural balance - Activities-specific Balance Confidence (ABC) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in ABC. The scale range is from 0 to 1600% (16 items which range from 0 to 100% each), being that as higher the score, higher the confidence

  13. Postural balance - Falls Efficacy Scale - International - Brasil (FES-I-Brasil) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in FES-I-Brasil. The scale range is from 0 to 64 (16 items which range from 0 to 4 points each), being that as higher the score, higher the worries about falls

  14. Peripheral muscle oxygenation during exercise and activities of daily living (oxyhemoglobin) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in oxyhemoglobin of NIRS PortaMon

  15. Peripheral muscle oxygenation during exercise and activities of daily living (deoxyhemoglobin) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in deoxyhemoglobin of NIRS PortaMon

  16. Peripheral muscle oxygenation during exercise and activities of daily living (total hemoglobin) [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in total hemoglobin of NIRS PortaMon

  17. Peripheral muscle oxygenation during exercise and activities of daily living [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change tissue saturation index of NIRS PortaMon

  18. Motivation - Amotivation [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in amotivation to exercise practice will be assessed by the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2). Amotivation is scored with the sum of items 5,9,12,19 divided by 4. The score ranges between 0-4 (units on a scale). The higher the score, the greater the amotivation to exercise.

  19. Motivation - External regulation [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in external regulation to exercise practice will be assessed by the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2). External regulation is scored with the sum of items 1,6,11,16 divided by 4. The score ranges between 0-4 (units on a scale). The higher the score, the greater the external regulation to exercise.

  20. Motivation - Identified regulation [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in identified regulation to exercise practice will be assessed by the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2). Identified regulation is scored with the sum of items 3,8,14,17 divided by 4. The score ranges between 0-4 (units on a scale). The higher the score, the greater the identified regulation to exercise.

  21. Motivation - Introjected regulation [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in introjected regulation to exercise practice will be assessed by the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2). Introjected regulation is scored with the sum of items 2,7,13 divided by 3. The score ranges between 0-4 (units on a scale). The higher the score, the greater the external introjected regulation to exercise.

  22. Motivation - Intrinsic regulation [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in intrinsic regulation to exercise practice will be assessed by the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2). Intrinsic regulation is scored with the sum of items 3,8,14,17 divided by 4. The score ranges between 0-4 (units on a scale). The higher the score, the greater the intrinsic regulation to exercise.

  23. Motivation - Self determination [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in self determination to exercise practice will be assessed by the Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2). Self-determination index (SDI) will be scored based on the equation: [(-3x amotivation)+(-2x external regulation)+(-1x introjected regulation)+(2x identified regulation)+(3x intrinsic regulation). It ranges between -24 (lowest SDI) to 20 (highest SDI). The higher the SDI score, the greater the motivation to exercise.

  24. General Self-efficacy [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in general self-efficacy to exercise assessed by the General self-efficacy scale. The score varies from 10 to 40. The higher the score, the greater the self-efficacy

  25. Disease-specific self-efficacy [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in disease-specific self-efficacy to exercise assessed by the COPD self-efficacy scale. The score ranges from 34 to 170 points. It can be also presented by a mean of the 34 items (sum of the items divided for 34). The higher the score, the greater the self-efficacy for both scales.

  26. Pulmonary Rehabilitation self-efficacy [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in pulmonary-rehabilitation related self-efficacy to exercise assessed by the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE). The score range comprises a score of 15 to 60, with higher scores indicating high levels of self-efficacy

  27. Basic Psychological Needs [ Time Frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP ]
    Change in basic psychological needs assessed by the Basic Psychological Needs in Exercise Scale (BPNES). The domains scores (autonomy, competence and relatedness) varies from 4 to 20. The higher the score, the greater the fulfillment of basic psychological needs.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of COPD confirmed by spirometry (COPD GOLD stages II, III and IV);
  • Clinical stability in the past four weeks.

Exclusion Criteria:

  • Hospital admission in the past 12 weeks;
  • Any other disease or health condition that could compromise the test´s execution or physical training;
  • Participation in pulmonary rehabilitation program completed in the last six months;
  • Current smoking or its cessation in less than six months;
  • Interruption of pulmonary rehabilitation program for any reason;
  • Any change in symptoms during the study protocol assessments.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692793


Contacts
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Contact: Anamaria F Mayer, PhD +5548 3664-8608 anamaria.mayer@udesc.br

Locations
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Brazil
Núcleo de Assistência, Ensino e Pesquisa em Reabilitação Pulmonar Recruiting
Florianópolis, SC, Brazil
Contact: Anamaria F Mayer, PhD    +5548 3664-8608    anamaria.mayer@udesc.br   
Sponsors and Collaborators
University of the State of Santa Catarina
Investigators
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Study Director: Anamaria F Mayer, PhD University of the State of Santa Catarina

Publications:
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Mölken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.
VLACHOPOULOS, S. P.; NTOUMANIS, N.; SMITH, A. L. The Basic Psychological Needs in Exercise Scale: Translation and evidence for cross-cultural validity. International Journal of Sport and Exercise Psychology, v. 8, p. 394-412, 2010.
SCHWARZER, R.; JERUSALÉM, M. Generalized Self-Efficacy scale. In: WEINMAN, J. e WRIGHT, M. J. Measures in health psychology: A user's portfolio. . Windsor, UK: NFER-NELSON, 1995.
MARKLAND, D.; TOBIN, V. A. A modification to the Behavioural Regulation in Exercise Questionnaire to include an assessment of amotivation. Journal of Sport and Exercise Psychology, v. 26, n. 2, p. 191-96, 2004.

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Responsible Party: Prof. Dra. Anamaria Fleig Mayer, Principal Investigator, University of the State of Santa Catarina
ClinicalTrials.gov Identifier: NCT03692793     History of Changes
Other Study ID Numbers: NuReabPRP
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The authors declared that will be shared: individual deidentified participant data; individual data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices); Study Protocol, Statistical Analysis Plan, Informed Consent Form; immediately following publication and ending 5 years following article publication; With Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose to achieve aims in the approved proposal; proposals should be directed to anamaria.mayer@udesc.br to gain access.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: immediately following publication and ending 5 years following article publication
Access Criteria: With Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose to achieve aims in the approved proposal; proposals should be directed to anamaria.mayer@udesc.br to gain access.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dra. Anamaria Fleig Mayer, University of the State of Santa Catarina:
Pulmonary Disease, Chronic Obstructive
Minimal Clinically Important Difference
Exercise Test
Rehabilitation
Disability Evaluation
Activities of Daily Living
Motivation
Self-efficacy
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive