COPDNCT03644888
Continuous Chest Wall Vibration in COPD Rehabilitation
A study testing Cycle ergometer training, Airway clearance program and Vibration therapy in people with COPD, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Dyspnea, the sensation of breathing discomfort or shortness of breath, is one of the main symptoms for patients affected by Chronic Obstructive Pulmonary Disease (COPD), particularly during exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Cycle ergometer training, Airway clearance program and Vibration therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2018to 30 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis (GOLD stage: 2-3-4)
Who cannot join
- Restrictive lung disease
- Active pulmonary infection
- Pulmonary embolism (less than 3 months)
- Pneumotorax
- Thoracic/abdominal operation (less than 3 months)
- Myocardial infarction (less than 6 months)
Show all 10Show fewer
- Congestive heart failure/ heart failure/ right heart failure
- Angina/severe angina
- Incapability of perform the cycle ergometer training (e.g. orthopaedic or urogenital conditions)
- Incapability to understand the intructions required to carry out the tests and assessments planned
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza
Rovato, Brescia, 25038
About this study
Official title: Effects of Continuous Chest Wall Vibration on Dyspnea and Exercise Tolerance in COPD Patients
Dyspnea, the sensation of breathing discomfort or shortness of breath, is one of the main symptoms for patients affected by Chronic Obstructive Pulmonary Disease (COPD), particularly during exercise. Previous study show that chest wall vibration decrease dyspnea in COPD patients and precisely when applied during the inspiration phase, called "in-phase vibration" (IPV) which provide vibration directly on intercostal muscles. These findings have been obtained in laboratory context and the intercostals muscles vibration has been tested only in single phases of breathing, during inspiration with IPV and during exhalation with out-of-phase vibration (OPV). None study has evaluated the effect of a continuous chest wall vibration (CCWV), namely muscles vibration during the whole cycle of breathing, on dyspnea in patients with COPD in a clinical context. Continuous high frequency vibration has been proven to reduce myoelectrical manifestation of fatigue, probably modifying the centrally driven motor unit recruitment hierarchy, in healthy subjects.
Moreover, CCWV is a modality of provide vibration more suitable and cost-effective in a clinical context than single-phases vibration that requires specific instruments for the detection of breathing phases and the coupling with vibration device.
On these bases, the investigators hypothesized that CCWV at high frequency, applied during a cycle ergometer training program, could decrease dyspnea and enhance the exercise tolerance in COPD patients. Therefore, the aim of this study is to evaluate the effects of high frequency CCWV on dyspnea and exercise tolerance in patients with COPD patients compared to usual care and to sham intervention.
- Conditions
- COPD
- Being tested
- Cycle ergometer training, Airway clearance program, Vibration therapy, Sham vibration therapy
- Keywords
- COPD, Vibration, Rehabilitation
- 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.
Cycle ergometer trainingOther
Already in arm/group descriptions
Airway clearance programOther
Already in arm/group descriptions
Vibration therapyDevice
Already in arm/group descriptions
Sham vibration therapyDevice
Already in arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Cycle ergometer training program: 2 minutes warm-up at no load, 20 minutes at 60% of peak work (PW) calculated by stress-test or at 50% of PW calculated according to Luxton equation (PW = 103.217 + (30.50 X gender) + (-1.613 X age) + (0.002 X 6MWW [m kg -1 ]). The progression of the workloads is calculated according to the BORG Dyspnea and Fatigue Scale (Borg D and F < 5: 10W increase; Borg D and/or F between 5 e 6: maintain same workload; Borg D and / or > 6: 10W decrease) Patient tailored airway clearance program guided by an experienced respiratory physical therapist, which could includes active cycle of breathing technique (ACBT), forced expiratory technique (FET), ELTGOL (slow expiration with glottis open in the lateral position) and PEP techniques (positive expiratory pressure). Receives: Other: Cycle ergometer training; Other: Airway clearance program |
| Experimental group | Experimental | Cycle ergometer training program plus application of vibration therapy. The vibration is provided at 150Hz via 4 effectors applied bilaterally at the second or third interspaces in the parasternal region of the upper chest wall and at the seventh to ninth interspaces anterior to the midaxillary line in the lower chest wall. Receives: Other: Cycle ergometer training; Other: Airway clearance program; Device: Vibration therapy |
| Sham intervention group | Sham comparator | Cycle ergometer training program plus application of sham vibration therapy: 4 effectors on chest-wall at same position of vibration therapy, the device that produces vibration is switched on, producing the typical noise and vibration is emitted by effectors not placed on the patient but left in place on the device. Receives: Other: Cycle ergometer training; Other: Airway clearance program; Device: Sham vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Dyspnea
Barthel Index based on dyspnea. The scale measures the level of dyspnea perceived in performing basic daily living activities, Range: 0 - 100 Higher values represent a worse outcome
Measured: Change from Baseline Barthel Index based on dyspnea at 4 weeks
Change of exercise tolerance
Six Minutes Walking Test. This test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Higher values represent a better outcome
Measured: Change from Baseline exercise tolerance at 4 weeks
Secondary outcomes (4)
Change of respiratory muscles strength
Maximum inspiratory pressure / Minimum expiratory pressure.
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are global measures of maximal strength of respiratory muscles and they are respectively the greater pressure which may be generated during maximal inspiration and expiration against an occluded airway. The way to measure maximal respiratory pressures is very simple, using a hand-held mouth pressure meter in cmH2O.
Higher values represent a better outcome
Measured: Change from Baseline respiratory muscles strength at 4 weeks
Change of Risk of death
BODE Index.
Is a multidimensional 10-point grading system that predicts the risk of death from any cause and from respiratory causes among patients with COPD. It is composed by subscales, combined to compute a total score as follows:
FEV1 (% of predicted): 0 (≥65); 1 (50-64); 2 (36-49); 3 (≤35). Distance walked in 6 minutes (m): 0 (≥350); 1 (250-349); 2 150-249); 3 (≤149). MMRC dyspnea scale:0 (0-1); 1 (2); 2 (3); 3 (4). Body-mass Index: 0 (>21); 1 (≤21).
Range: 0-10 Higher scores indicate a worse outcome (higher risk of death)
Measured: Change from Baseline risk of death at 4 weeks
Change of Health-related quality of life
Saint George Respiratory Questionnaire. Is a self-reported, disease-specific, health-related quality of life questionnaire.
Range: 0 (no health impairment) - 100 (maximum health impairment).
Higher values represent a worse outcome
Measured: Change from Baseline health-related quality at 4 weeks
Change of Sympatho-vagal balance
Heart Rate Variability
Measured: Change from Baseline sympatho-vagal balance at 2 weeks and at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start12 Sep 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Buraschi, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Riccardo Buraschi, DPT, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644888
- Sponsor's protocol ID
- Vibra_COPD_FDG
- Status last verified
- Feb 2020
- First submitted
- 17 Aug 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Binks AP, Bloch-Salisbury E, Banzett RB, Schwartzstein RM. Oscillation of the lung by chest-wall vibration. Respir Physiol. 2001 Jul;126(3):245-9. doi: 10.1016/s0034-5687(01)00223-7.
PubMed 11403786Bolser DC, Lindsey BG, Shannon R. Respiratory pattern changes produced by intercostal muscle/rib vibration. J Appl Physiol (1985). 1988 Jun;64(6):2458-62. doi: 10.1152/jappl.1988.64.6.2458.
PubMed 3403429Burke D, Hagbarth KE, Lofstedt L, Wallin BG. The responses of human muscle spindle endings to vibration during isometric contraction. J Physiol. 1976 Oct;261(3):695-711. doi: 10.1113/jphysiol.1976.sp011581.
PubMed 135841Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc Sport Sci Rev. 2003 Jan;31(1):3-7. doi: 10.1097/00003677-200301000-00002.
PubMed 12562163Cristiano LM, Schwartzstein RM. Effect of chest wall vibration on dyspnea during hypercapnia and exercise in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 May;155(5):1552-9. doi: 10.1164/ajrccm.155.5.9154856.
PubMed 9154856Fallon JB, Macefield VG. Vibration sensitivity of human muscle spindles and Golgi tendon organs. Muscle Nerve. 2007 Jul;36(1):21-9. doi: 10.1002/mus.20796.
PubMed 17471568Casale R, Ring H, Rainoldi A. High frequency vibration conditioning stimulation centrally reduces myoelectrical manifestation of fatigue in healthy subjects. J Electromyogr Kinesiol. 2009 Oct;19(5):998-1004. doi: 10.1016/j.jelekin.2008.08.002. Epub 2008 Sep 26.
PubMed 18819821Nakayama H, Shibuya M, Kaneko N, Yamada M, Suzuki H, Arakawa M, Homma I. Benefit of in-phase chest wall vibration on the pulmonary hemodynamics in patients with chronic obstructive pulmonary disease. Respirology. 1998 Dec;3(4):235-40. doi: 10.1111/j.1440-1843.1998.tb00128.x.
PubMed 10201049Nakayama H, Shibuya M, Yamada M, Suzuki H, Arakawa M, Homma I. In-phase chest wall vibration decreases dyspnea during arm elevation in chronic obstructive pulmonary disease patients. Intern Med. 1998 Oct;37(10):831-5. doi: 10.2169/internalmedicine.37.831.
PubMed 9840703Sibuya M, Yamada M, Kanamaru A, Tanaka K, Suzuki H, Noguchi E, Altose MD, Homma I. Effect of chest wall vibration on dyspnea in patients with chronic respiratory disease. Am J Respir Crit Care Med. 1994 May;149(5):1235-40. doi: 10.1164/ajrccm.149.5.8173764.
PubMed 8173764Bausewein C, Booth S, Gysels M, Higginson I. Non-pharmacological interventions for breathlessness in advanced stages of malignant and non-malignant diseases. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005623. doi: 10.1002/14651858.CD005623.pub2.
PubMed 18425927Pancera S, Buraschi R, Bianchi LNC, Porta R, Negrini S, Arienti C. Effectiveness of Continuous Chest Wall Vibration With Concurrent Aerobic Training on Dyspnea and Functional Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Aug;102(8):1457-1464. doi: 10.1016/j.apmr.2021.03.006. Epub 2021 Mar 26.
PubMed 33781780
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Chest Wall Vibration on Dyspnea and Exercise Tolerance in COPD Patients
- ClinicalTrials.gov ID
- NCT03644888
- Acronym / sponsor ID
- Vibra_COPD_FDG
- Conditions
- COPD
- Keywords
- COPD, Vibration, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Aug 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.
Dyspnea, the sensation of breathing discomfort or shortness of breath, is one of the main symptoms for patients affected by Chronic Obstructive Pulmonary Disease (COPD), particularly during exercise. Previous study show that chest wall vibration decrease dyspnea in COPD patients and precisely when applied during the inspiration phase, called "in-phase vibration" (IPV) which provide vibration directly on intercostal muscles. These findings have been obtained in laboratory context and the intercostals muscles vibration has been tested only in single phases of breathing, during inspiration with IPV and during exhalation with out-of-phase vibration (OPV). None study has evaluated the effect of a continuous chest wall vibration (CCWV), namely muscles vibration during the whole cycle of breathing, on dyspnea in patients with COPD in a clinical context. Continuous high frequency vibration has been proven to reduce myoelectrical manifestation of fatigue, probably modifying the centrally driven motor unit recruitment hierarchy, in healthy subjects.
Moreover, CCWV is a modality of provide vibration more suitable and cost-effective in a clinical context than single-phases vibration that requires specific instruments for the detection of breathing phases and the coupling with vibration device.
On these bases, the investigators hypothesized that CCWV at high frequency, applied during a cycle ergometer training program, could decrease dyspnea and enhance the exercise tolerance in COPD patients. Therefore, the aim of this study is to evaluate the effects of high frequency CCWV on dyspnea and exercise tolerance in patients with COPD patients compared to usual care and to sham intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Cycle ergometer training, Other: Airway clearance programCycle ergometer training program: 2 minutes warm-up at no load, 20 minutes at 60% of peak work (PW) calculated by stress-test or at 50% of PW calculated according to Luxton equation (PW = 103.217 + (30.50 X gender) + (-1.613 X age) + (0.002 X 6MWW [m kg -1 ]). The progression of the workloads is calculated according to the BORG Dyspnea and Fatigue Scale (Borg D and F < 5: 10W increase; Borg D and/or F between 5 e 6: maintain same workload; Borg D and / or > 6: 10W decrease) Patient tailored airway clearance program guided by an experienced respiratory physical therapist, which could includes active cycle of breathing technique (ACBT), forced expiratory technique (FET), ELTGOL (slow expiration with glottis open in the lateral position) and PEP techniques (positive expiratory pressure). |
| Experimental group | Experimental | Other: Cycle ergometer training, Other: Airway clearance program, Device: Vibration therapyCycle ergometer training program plus application of vibration therapy. The vibration is provided at 150Hz via 4 effectors applied bilaterally at the second or third interspaces in the parasternal region of the upper chest wall and at the seventh to ninth interspaces anterior to the midaxillary line in the lower chest wall. |
| Sham intervention group | Sham comparator | Other: Cycle ergometer training, Other: Airway clearance program, Device: Sham vibration therapyCycle ergometer training program plus application of sham vibration therapy: 4 effectors on chest-wall at same position of vibration therapy, the device that produces vibration is switched on, producing the typical noise and vibration is emitted by effectors not placed on the patient but left in place on the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD diagnosis (GOLD stage: 2-3-4)
Key exclusion criteria (10 listed)
- Restrictive lung disease
- Active pulmonary infection
- Pulmonary embolism (less than 3 months)
- Pneumotorax
- Thoracic/abdominal operation (less than 3 months)
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 |
|---|---|---|
| Cycle ergometer trainingAlready in arm/group descriptions | Other | Control group, Experimental group, Sham intervention group |
| Airway clearance programAlready in arm/group descriptions | Other | Control group, Experimental group, Sham intervention group |
| Vibration therapyAlready in arm/group descriptions | Device | Experimental group |
| Sham vibration therapyAlready in arm/group descriptions | Device | Sham intervention group |
Primary outcome
Change of Dyspnea
Time frame: Change from Baseline Barthel Index based on dyspnea at 4 weeks
Barthel Index based on dyspnea. The scale measures the level of dyspnea perceived in performing basic daily living activities, Range: 0 - 100 Higher values represent a worse outcome
Change of exercise tolerance
Time frame: Change from Baseline exercise tolerance at 4 weeks
Six Minutes Walking Test. This test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. Higher values represent a better outcome
4 secondary outcomes
Change of respiratory muscles strength
Time frame: Change from Baseline respiratory muscles strength at 4 weeks
Change of Risk of death
Time frame: Change from Baseline risk of death at 4 weeks
Change of Health-related quality of life
Time frame: Change from Baseline health-related quality at 4 weeks
Change of Sympatho-vagal balance
Time frame: Change from Baseline sympatho-vagal balance at 2 weeks and at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 11403786Binks AP, Bloch-Salisbury E, Banzett RB, Schwartzstein RM. Oscillation of the lung by chest-wall vibration. Respir Physiol. 2001 Jul;126(3):245-9. doi: 10.1016/s0034-5687(01)00223-7.
- Background: PubMed 3403429Bolser DC, Lindsey BG, Shannon R. Respiratory pattern changes produced by intercostal muscle/rib vibration. J Appl Physiol (1985). 1988 Jun;64(6):2458-62. doi: 10.1152/jappl.1988.64.6.2458.
- Background: PubMed 135841Burke D, Hagbarth KE, Lofstedt L, Wallin BG. The responses of human muscle spindle endings to vibration during isometric contraction. J Physiol. 1976 Oct;261(3):695-711. doi: 10.1113/jphysiol.1976.sp011581.
- Background: PubMed 12562163Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc Sport Sci Rev. 2003 Jan;31(1):3-7. doi: 10.1097/00003677-200301000-00002.
- Background: PubMed 9154856Cristiano LM, Schwartzstein RM. Effect of chest wall vibration on dyspnea during hypercapnia and exercise in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 May;155(5):1552-9. doi: 10.1164/ajrccm.155.5.9154856.
- Background: PubMed 17471568Fallon JB, Macefield VG. Vibration sensitivity of human muscle spindles and Golgi tendon organs. Muscle Nerve. 2007 Jul;36(1):21-9. doi: 10.1002/mus.20796.
- Background: PubMed 18819821Casale R, Ring H, Rainoldi A. High frequency vibration conditioning stimulation centrally reduces myoelectrical manifestation of fatigue in healthy subjects. J Electromyogr Kinesiol. 2009 Oct;19(5):998-1004. doi: 10.1016/j.jelekin.2008.08.002. Epub 2008 Sep 26.
- Background: PubMed 10201049Nakayama H, Shibuya M, Kaneko N, Yamada M, Suzuki H, Arakawa M, Homma I. Benefit of in-phase chest wall vibration on the pulmonary hemodynamics in patients with chronic obstructive pulmonary disease. Respirology. 1998 Dec;3(4):235-40. doi: 10.1111/j.1440-1843.1998.tb00128.x.
- Background: PubMed 9840703Nakayama H, Shibuya M, Yamada M, Suzuki H, Arakawa M, Homma I. In-phase chest wall vibration decreases dyspnea during arm elevation in chronic obstructive pulmonary disease patients. Intern Med. 1998 Oct;37(10):831-5. doi: 10.2169/internalmedicine.37.831.
- Background: PubMed 8173764Sibuya M, Yamada M, Kanamaru A, Tanaka K, Suzuki H, Noguchi E, Altose MD, Homma I. Effect of chest wall vibration on dyspnea in patients with chronic respiratory disease. Am J Respir Crit Care Med. 1994 May;149(5):1235-40. doi: 10.1164/ajrccm.149.5.8173764.
- Background: PubMed 18425927Bausewein C, Booth S, Gysels M, Higginson I. Non-pharmacological interventions for breathlessness in advanced stages of malignant and non-malignant diseases. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005623. doi: 10.1002/14651858.CD005623.pub2.
- Derived from this study: PubMed 33781780Pancera S, Buraschi R, Bianchi LNC, Porta R, Negrini S, Arienti C. Effectiveness of Continuous Chest Wall Vibration With Concurrent Aerobic Training on Dyspnea and Functional Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Aug;102(8):1457-1464. doi: 10.1016/j.apmr.2021.03.006. Epub 2021 Mar 26.
- Individual participant dataSharing planned: Undecided
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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.
Riccardo Buraschi, DPT principal investigator
IRCCS Fondazione Don Carlo Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle ergometer training, Airway clearance program and Vibration therapy in people with COPD, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 5 Feb 2020. 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 Italy. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of Dyspnea (time frame: Change from Baseline Barthel Index based on dyspnea at 4 weeks). The study lists 2 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 NCT03644888, which also lists 12 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 5 Feb 2020.