Pulmonary Disease, Chronic ObstructiveNCT03692793
Pulmonary Rehabilitation in Functional Outcomes and Its Relationship With Morbidity and Mortality in Patients With COPD
A study testing Pulmonary rehabilitation in people with Pulmonary Disease, Chronic Obstructive, run by University of the State of Santa Catarina at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2013to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD confirmed by spirometry (COPD GOLD stages II, III and IV);
- Clinical stability in the past four weeks.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Núcleo de Assistência, Ensino e Pesquisa em Reabilitação Pulmonar
Florianópolis, Santa Catarina
About this study
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
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
Read more
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Pulmonary rehabilitation
- Keywords
- Pulmonary Disease, Chronic Obstructive, Minimal Clinically Important Difference, Exercise Test, Rehabilitation, Disability Evaluation, Activities of Daily Living, Motivation, Self-efficacy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
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 group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Experimental | The PRP (24-session, three times for week) will be delivered according to ATS/ERS (Spruit et al, 2013), Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity in daily life
Change in physical activity in daily life monitoring by accelerometry
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Morbidity
Relationship of changes in outcomes with exacerbation, hospitalization and death
Measured: Every month after the PRP up to 24 months
Mortality
Relationship of changes in outcomes with death
Measured: Every month after the PRP up to 24 months
Secondary outcomes (27)
Dyspnea
modified Medical Research Council (mMRC) scale. The scale range is from 0 to 5, being that higher values correspond to worse dyspnea
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Health status - COPD Assessment Test (CAT)
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
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Health status - Saint George Respiratory questionnaire (SGRQ)
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
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Anxiety and depression symptoms - Hospital Anxiety and Depression Scale (HADS)
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
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Functional status - Glittre-ADL Test (TGlittre)
Change in TGlittre
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Functional status - Six-Minute Walk Test (6MWT)
Change in 6MWT
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Functional status - London Chest Activity of Daily Living (LCADL)
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
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Postural balance - force platform NeuroCom (COP)
Change center of pressure (COP) displacement
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Postural balance - force platform NeuroCom (COG)
Change in center of gravity (COG) displacement
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Postural balance -Timed Up and Go (TUG) Test
Change in TUG Test
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Postural balance - Berg Balance Scale (BBS)
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
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Postural balance - Activities-specific Balance Confidence (ABC)
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
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Postural balance - Falls Efficacy Scale - International - Brasil (FES-I-Brasil)
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
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Peripheral muscle oxygenation during exercise and activities of daily living (oxyhemoglobin)
Change in oxyhemoglobin of NIRS PortaMon
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Peripheral muscle oxygenation during exercise and activities of daily living (deoxyhemoglobin)
Change in deoxyhemoglobin of NIRS PortaMon
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Peripheral muscle oxygenation during exercise and activities of daily living (total hemoglobin)
Change in total hemoglobin of NIRS PortaMon
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Peripheral muscle oxygenation during exercise and activities of daily living
Change tissue saturation index of NIRS PortaMon
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - Amotivation
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.
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - External regulation
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.
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - Identified regulation
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.
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - Introjected regulation
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.
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - Intrinsic regulation
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.
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - Self determination
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.
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
General Self-efficacy
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
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Disease-specific self-efficacy
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.
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Pulmonary Rehabilitation self-efficacy
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
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Basic Psychological Needs
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.
Measured: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Apr 2013
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: Due to the Covid-19 pandemic, face-to-face activities have been suspended since March 2020, making the research unfeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dra. Anamaria Fleig Mayer, University of the State of Santa Catarina
- Investigators
- Anamaria F Mayer, PhD, Study director, University of the State of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692793
- Sponsor's protocol ID
- NuReabPRP
- Status last verified
- Apr 2021
- First submitted
- 16 Sep 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
PubMed 17982531Spruit 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 Molken 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.
PubMed 24127811Garrod R, Bestall JC, Paul EA, Wedzicha JA, Jones PW. Development and validation of a standardized measure of activity of daily living in patients with severe COPD: the London Chest Activity of Daily Living scale (LCADL). Respir Med. 2000 Jun;94(6):589-96. doi: 10.1053/rmed.2000.0786.
PubMed 10921765Carpes MF, Mayer AF, Simon KM, Jardim JR, Garrod R. The Brazilian Portuguese version of the London Chest Activity of Daily Living scale for use in patients with chronic obstructive pulmonary disease. J Bras Pneumol. 2008 Mar;34(3):143-51. doi: 10.1590/s1806-37132008000300004. English, Portuguese.
PubMed 18392462Kovelis 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. doi: 10.1590/s1806-37132008001200005. English, Portuguese.
PubMed 19180335Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
PubMed 19720809Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.
PubMed 15941658Pitta F, Troosters T, Probst VS, Spruit MA, Decramer M, Gosselink R. Quantifying physical activity in daily life with questionnaires and motion sensors in COPD. Eur Respir J. 2006 May;27(5):1040-55. doi: 10.1183/09031936.06.00064105.
PubMed 16707399Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.
PubMed 24603844Botega NJ, Bio MR, Zomignani MA, Garcia C Jr, Pereira WA. [Mood disorders among inpatients in ambulatory and validation of the anxiety and depression scale HAD]. Rev Saude Publica. 1995 Oct;29(5):355-63. doi: 10.1590/s0034-89101995000500004. Portuguese.
PubMed 8731275Silva PN, Jardim JR, Costa e Souza GM, Hyland ME, Nascimento OA. Cultural adaptation and reproducibility of the Breathing Problems Questionnaire for use in patients with COPD in Brazil. J Bras Pneumol. 2012 May-Jun;38(3):339-45. doi: 10.1590/s1806-37132012000300009. English, Portuguese.
PubMed 22782604Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.
PubMed 1759018
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03692793
- Acronym / sponsor ID
- NuReabPRP
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Minimal Clinically Important Difference, Exercise Test, Rehabilitation, Disability Evaluation, Activities of Daily Living, Motivation, Self-efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the Covid-19 pandemic, face-to-face activities have been suspended since March 2020, making the research unfeasible.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Other: Pulmonary rehabilitationThe PRP (24-session, three times for week) will be delivered according to ATS/ERS (Spruit et al, 2013), |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of COPD confirmed by spirometry (COPD GOLD stages II, III and IV);
- Clinical stability in the past four weeks.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationPatients 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. | Other | Pulmonary rehabilitation |
Primary outcome
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
27 secondary outcomes
Dyspnea
Time frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Motivation - Amotivation
Time frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - External regulation
Time frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - Identified regulation
Time frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - Introjected regulation
Time frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - Intrinsic regulation
Time frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Motivation - Self determination
Time frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
General Self-efficacy
Time frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
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
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
Basic Psychological Needs
Time frame: baseline, post-24 sessions of PRP, six months post-PRP, 12 months post-PRP and 24 months post-PRP
Results and safety
The study was stopped early (reason given: Due to the Covid-19 pandemic, face-to-face activities have been suspended since March 2020, making the research unfeasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Background: PubMed 17982531Pereira CA, Sato T, Rodrigues SC. New reference values for forced spirometry in white adults in Brazil. J Bras Pneumol. 2007 Jul-Aug;33(4):397-406. doi: 10.1590/s1806-37132007000400008. English, Portuguese.
- Background: PubMed 24127811Spruit 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 Molken 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.
- Background: PubMed 10921765Garrod R, Bestall JC, Paul EA, Wedzicha JA, Jones PW. Development and validation of a standardized measure of activity of daily living in patients with severe COPD: the London Chest Activity of Daily Living scale (LCADL). Respir Med. 2000 Jun;94(6):589-96. doi: 10.1053/rmed.2000.0786.
- Background: PubMed 18392462Carpes MF, Mayer AF, Simon KM, Jardim JR, Garrod R. The Brazilian Portuguese version of the London Chest Activity of Daily Living scale for use in patients with chronic obstructive pulmonary disease. J Bras Pneumol. 2008 Mar;34(3):143-51. doi: 10.1590/s1806-37132008000300004. English, Portuguese.
- Background: PubMed 19180335Kovelis 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. doi: 10.1590/s1806-37132008001200005. English, Portuguese.
- Background: PubMed 19720809Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
- Background: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Background: PubMed 15941658Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.
- Background: PubMed 16707399Pitta F, Troosters T, Probst VS, Spruit MA, Decramer M, Gosselink R. Quantifying physical activity in daily life with questionnaires and motion sensors in COPD. Eur Respir J. 2006 May;27(5):1040-55. doi: 10.1183/09031936.06.00064105.
- Background: PubMed 24603844Demeyer H, Burtin C, Van Remoortel H, Hornikx M, Langer D, Decramer M, Gosselink R, Janssens W, Troosters T. Standardizing the analysis of physical activity in patients with COPD following a pulmonary rehabilitation program. Chest. 2014 Aug;146(2):318-327. doi: 10.1378/chest.13-1968.
- Background: PubMed 8731275Botega NJ, Bio MR, Zomignani MA, Garcia C Jr, Pereira WA. [Mood disorders among inpatients in ambulatory and validation of the anxiety and depression scale HAD]. Rev Saude Publica. 1995 Oct;29(5):355-63. doi: 10.1590/s0034-89101995000500004. Portuguese.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anamaria F Mayer, PhD study director
University of the State of Santa Catarina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Pulmonary Disease, Chronic Obstructive, run by University of the State of Santa Catarina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the Covid-19 pandemic, face-to-face activities have been suspended since March 2020, making the research unfeasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692793, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.