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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

Tracking Information
First Submitted Date  ICMJE September 16, 2018
First Posted Date  ICMJE October 2, 2018
Last Update Posted Date October 2, 2018
Actual Study Start Date  ICMJE April 1, 2013
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2018)
  • 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
  • Morbidity [ Time Frame: Every month after the PRP up to 24 months ]
    Relationship of changes in outcomes with exacerbation, hospitalization and death
  • Mortality [ Time Frame: Every month after the PRP up to 24 months ]
    Relationship of changes in outcomes with death
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulmonary Rehabilitation in Functional Outcomes and Its Relationship With Morbidity and Mortality in Patients With COPD
Official Title  ICMJE 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
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.

Detailed Description

Assigned Interventions: Pulmonary rehabilitation program (PRP) will be conducted according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Physical training will be conducted over 24 sessions supervised, three times a week. The program will include aerobic training in treadmill (with 30 min load determined by the dyspnea sensation - 4 to 6 on the modified Borg scale) and resistance training for upper limbs with free weights or elastic bands (movements performed based on the proprioceptive neuromuscular facilitation diagonals, performed in two series, lasting two minutes each) and lower limbs (quadriceps and triceps sural) with free weights and/or in the bodybuilding station. All the muscle exercised and the breathing accessory muscles will be stretched for 30s each. Eleven 30-minute educational sessions will be delivered addressing topics related to disease self-management.

The death cases and numbers of exacerbations and hospitalizations will be measured by monthly phone calls after PRP.

Before PRP, post-PRP, 6 months post-PRP and 12 months post-PRP will be evaluated:

Pulmonary function test: Spirometry (EasyOne, NDD) or Total Body Plethysmography (Eric Jaeger, Germany) will be performed in accordance with ATS/ERS standards in order to provide the level of pulmonary obstruction and severity of disease. The predicted values will be calculated with the equations derived from Brazilian population.

Triaxial Accelerometry by Dynaport Activity Monitor: In order to evaluate the physical activity in daily life (PADL), it will be used DynaPort Activity Monitor (McRoberts BV®, Netherlands). Monitoring took place on four consecutive days lasting 12 hours from awakening. Data processing and analysis will be performed with the Dyrector software (McRoberts BV®).

Glittre-ADL Test (TGlittre): The patients will be instructed to complete the circuit described by Skumlien et al. In one day, the patients will perform two Glittre-ADL Tests with the orientation of performing the test in the shortest possible time. On the other day, two tests will also be performed, however, the patients will be instructed to perform the circuit at his usual speed (TGlittre-Perf). The order of execution of TGlittre and TGlittre-Perf will be randomized previously.

Six minute walk test (6MWT): The patients will be instructed to walk in order to perform the largest distance during six minutes. The walking speed will be selected by the patient, according to the guidelines of the ATS. Two 6MWTs will be conducted on tracks of 20 and 30 meters, in different days, with execution order randomized previously.

Peripheral muscle oxygenation: The patients will use a near-infrared spectroscopy device (NIRS PortaLite®, Artinis Medical Systems) on the vastus lateralis muscle of the dominant lower limb during TGlittre, TGlittre-Perf and 6MWT. The positioning will follow the SENIAM Project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) recommendations. The analyzed variables will be oxyhemoglobin, deoxyhemoglobin, total hemoglobin and tissue saturation index.

Postural control: The patients will perform five protocols randomized previously on force platform NeuroCom® SMART Equitest® (Sensory Organization Test, Adaptation Control Test, Motor Control Test, Limits of Stability, Rhythmic Weight Shift e Weight Bearing Squat). Besides, they will perform two Timed Up and Go Test in the shortest possible time and Berg Balance Scale, composed of 14 specific items with different tasks. The Activities-specific Balance Confidence and Falls Efficacy Scale - International - Brasil, both composed for 16 items related to ADL confidence and self-efficacy for falls, respectively, also will be performed. The postural control assessment will be randomized previously.

London Chest Activity of Daily Living scale: Patients will be asked about their perception of limitation in activities of daily living, using the London Chest Activity of Daily Living scale. It consists of 15 items with scores from 0 to 5, with the total score ranging from 0 to 75 points. The higher the score is, the greater the ADL limitation.

Modified Medical Research Council scale: Patients will be asked about their perception of dyspnea, using the modified Medical Research Council scale. The scale range is from 0 to 5, being that higher values correspond to worse dyspnea.

Saint George Respiratory Questionnaire: Patients will be asked about their perception of health-related quality of life, using the Saint George Respiratory Questionnaire. The SGRQ score ranges from 0 to 100% (total and three domains: symptoms, activity and impact), being that higher values correspond to worse quality of life.

COPD Assessment Test: Patients will be asked about the perception of the impact of COPD (cough, sputum, dyspnea, and chest tightness) on health status, using COPD Assessment Test. The total score varies from 0 to 40 and higher scores indicate greater impact of the disease on the health status of these patients.

Hospital Anxiety and Depression Scale: The Hospital Anxiety and Depression Scale will be applied to evaluated symptoms of anxiety and depression. It has two subscales: anxiety and depression. Each subscale generates a final score ranging from 0 to 21 points. Higher scores to more symptoms.

Behavioural Regulation in Exercise Questionnaire-2 (BREQ-2): the questionnaire assesses motivation to exercise. It consists of 19 Likert-based items that measure motivation to exercise. The self-determination index (SDI) will be scored. It ranges between -24 (lowest SDI) to 20 (highest SDI). The higher the SDI score, the greater the motivation to exercise.

Basic Psychological Needs in Exercise Scale: it assesses the patient´s perception regarding the supply of basic psychological needs and with the exercise. It is composed by 12 items that are divided into three domains: autonomy (four items), competence (four items), and relatedness (four items). Each item varies from from 1 ("totally disagree") to 5 ("very strongly agree"). The domains scores varies from 4 to 20. The higher the score, the greater the fulfillment of basic psychological needs.

COPD self-efficacy scale: the scales will be used to assess disease-specific self-efficacy. It assesses an individual's confidence in managing dyspnoea or other breathing-related issues. It is a Likert-based scale, consisting of 34 items divided into the following 5 subscales: negative affect (12 items), intense emotional arousal (8 items), physical exertion (5 items), weather or environment (6 items), behavioural risk factors (3 items). The total 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.

General self-efficacy scale: the scales will be used to assess general self-efficacy. It is a 10-item Likert-based scale, whose score varies from 10 to 40. The higher the score, the greater the self-efficacy.

Pulmonary Rehabilitation Adapted Index of Self-Efficacy: the scale will assess self-efficacy in the context of PR. It is composed by 10 items from the General Self-efficacy Scale and 5 items specific to challenges faced by patients attending a pulmonary rehabilitation program. Each item is scored from 1 to 4, with 4 being the highest level of perceived self-efficacy and 1 being considered the lowest level. The score range comprises a score of 15 to 60, with higher scores indicating high levels of self-efficacy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Pulmonary rehabilitation
The PRP (24-session, three times for week) will be delivered according to ATS/ERS (Spruit et al, 2013),
Intervention: Other: Pulmonary rehabilitation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anamaria F Mayer, PhD +5548 3664-8608 anamaria.mayer@udesc.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03692793
Other Study ID Numbers  ICMJE NuReabPRP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Responsible Party Prof. Dra. Anamaria Fleig Mayer, University of the State of Santa Catarina
Study Sponsor  ICMJE University of the State of Santa Catarina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anamaria F Mayer, PhD University of the State of Santa Catarina
PRS Account University of the State of Santa Catarina
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP