COPDNCT04722224
Home-based Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
A study testing Home-based pulmonary rehabilitation in people with COPD, run by Polytechnic Institute of Porto at 1 site in Portugal.
Trial summary
This project aims to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation (PR) program (reabilitAR) in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD
- What is being tested?
- Home-based pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 4 Jan 2021to 17 Jan 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD based on the GOLD criteria - postbronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <70%;
- Electrocardiogram (ECG) record at rest;
- Written informed consent form;
Who cannot join
- Presence of any clinical condition that does not allow the participants to a home-based PR program, such as, significant cardiovascular (e.g. symptomatic ischaemic cardiac disease), neurological (e.g. neuromuscular dystrophy disease), or presence of musculoskeletal disease;
- Signs of cognitive impairment (e.g. dementia).
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Rui Vilarinho
Porto, 4200-072
Rui Vilarinho, 917521184, ruivilarinho1@gmail.com
About this study
This project aims to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation (PR) program (reabilitAR) in patients with chronic obstructive pulmonary disease (COPD). It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure).
Patients will be recruited at hospitals. Sociodemographic, anthropometric, and comorbidities; vital signs and peripheral oxygen saturation; symptoms (dyspnea, fatigue); lung function; functional capacity; exercise capacity; the impact of the disease, balance, and cognitive function will be collected before the reabilitAR program. Additionally, health care utilization will be registered. Then, patients will be entered into the reabilitAR program (12 weeks). The intervention consists in a strategic mixture of home visits and phone calls. The program includes exercise training and the self-management educational program Living Well with COPD. After 12 weeks all outcome measures will be reassessed.
It is expected that the home-based approach will express benefits and reflect the concerns to provide appropriate responses to the patient's needs by increasing access to PR.
Read the detailed description
The World Health Organization (WHO) indicates that hundreds of millions of people worldwide are affected by chronic respiratory diseases (CRD), including chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) is an essential component in the management of CRD with the aim to improve patients' exercise and functional capacity and psychological condition with long-term adherence to health-enhancing behaviors, including exercise training and self-management skills.
However, despite the well-known evidence, this service is mostly underutilized due to poor accessibility, with only 1% of worldwide availability of PR services for COPD patients. Thus, is important to undertake actions that improve access to and delivery of PR services for suitable patients. One of the strategies in the international guidelines is the creation of new models of programs, where a home-based approach is indicated.
The aim of this project is to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation program (reabilitAR) in patients with COPD. It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure).
The plan is to recruit the maximum of patients with COPD via clinicians at hospitals. This study will enroll adult patients with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Patients will be referred by pulmonologists, from medical consultation in hospitals and clinics in Portugal. With the referral, it is expected that the medical doctor explains the goal and benefits of PR. Eligible patients will be contacted by the reabilitAR team, for additional questions and to begin the integration process.
Sociodemographic, anthropometric, and comorbidities; vital signs and peripheral oxygen saturation; symptoms (dyspnea, fatigue); lung function; functional capacity; exercise capacity; the impact of the disease, balance, and cognitive function will be collected before the reabilitAR program. Additionally, health care utilization will be registered.
The program consists in home visits for the exercise training and the self-management sessions, and motivational phone-calls including the follow-up of the clinical condition, the progression of exercise training, including a total of 14 home visits, with more visits in the first two weeks of the program (4 visits). From the third week, one visit will be replaced by a phone call, for a total of 10 phone calls.
After 12 weeks all outcome measures will be reassessed.
- Conditions
- COPD
- Being tested
- Home-based pulmonary rehabilitation
- Keywords
- home-based pulmonary rehabilitation, exercise training, self-management
- 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.
Home-based pulmonary rehabilitationOther
The reabilitAR program includes the self-management educational program Living Well with COPD. The exercise training will include endurance, resistance/strength, flexibility and balance training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Home-based pulmonary rehabilitation | Experimental | Patients will be treated for 12 weeks. The intervention consists in a strategic mixture of home visits and phone calls. The program includes exercise training and the self-management educational program Living Well with COPD. Receives: Other: Home-based pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline number of steps (incremental step test) at 12 weeks
The incremental step test will be used to assess exercise capacity
Measured: At baseline and up to 12 weeks
Secondary outcomes (8)
Change from baseline number of repetitions (1-minute sit-to-stand test) at 12 weeks
The 1-minute sit-to-stand test will be used to assess functional capacity
Measured: At baseline and up to 12 weeks
Change from baseline score of CAT at 12 weeks
COPD Assessment Test (CAT) will be used to assess impact of the disease. The individual score of each item is added to provide a total score that can range from 0 to 40. Total scores inferior to 10 are considered as "reduced impact", from 10-20 as "medium impact", from 21- 30 as "high impact" and above 30 as "very high impact".
Measured: At baseline and up to 12 weeks
Change from baseline score of dyspnea at 12 weeks
Modified Borg scale will be used to assess patients' level of dyspnea. 0-10 scale is used to measure perceived dyspnea where 0 is "not at all" and 10 is "maximal"
Measured: At baseline and up to 12 weeks
Change from baseline score of fatigue at 12 weeks
Modified Borg Scale will be used to assess patients' level of fatigue. 0-10 scale is used to measure perceived fatigue where 0 is "not at all" and 10 is "maximal"
Measured: At baseline and up to 12 weeks
Change from baseline score of London Chest Activities of Daily Living at 12 weeks
London Chest Activities of Daily Living will be used to assess patients' level of dyspnea performing activities of daily living. The individual score of each item is added to provide a total score that can range from 0 to 75 where maximal score represents a higher level of dyspnea.
Measured: At baseline and up to 12 weeks
Change from baseline score of Hospital Anxiety and Depression Scale at 12 weeks
Hospital Anxiety and Depression Scale will be used to assess patients' emotional status. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression symptoms.
Measured: At baseline and up to 12 weeks
Number of exacerbations
Patients' number of hospitalizations in the previous year and during the rehabilitation will be assessed by asking the patient to self-report it.
Measured: Up to 12 weeks
Change from baseline score of mMRC at 12 weeks
Modified British Medical Research Council (mMRC) questionnaire will be used to assess patients' level of dyspnea.This questionnaire comprises five grades in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation.
Measured: At baseline and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start4 Jan 2021
- Primary completion30 Sep 2023
- Study completion17 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polytechnic Institute of Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Nippon Gases Portugal
- Responsible party
- Principal investigator, Rui Vilarinho, Polytechnic Institute of Porto
- Investigators
- Rui A Vilarinho, Master, Principal investigator, School of Health, Polytechnic Institute of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722224
- Sponsor's protocol ID
- reabilitar_DPOC_2
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2021
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van 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 24127811Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.
PubMed 26623686Bui KL, Nyberg A, Maltais F, Saey D. Functional Tests in Chronic Obstructive Pulmonary Disease, Part 1: Clinical Relevance and Links to the International Classification of Functioning, Disability, and Health. Ann Am Thorac Soc. 2017 May;14(5):778-784. doi: 10.1513/AnnalsATS.201609-733AS.
PubMed 28244799Bui KL, Nyberg A, Maltais F, Saey D. Functional Tests in Chronic Obstructive Pulmonary Disease, Part 2: Measurement Properties. Ann Am Thorac Soc. 2017 May;14(5):785-794. doi: 10.1513/AnnalsATS.201609-734AS.
PubMed 28244801Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008 Feb;61(2):102-9. doi: 10.1016/j.jclinepi.2007.03.012. Epub 2007 Aug 3.
PubMed 18177782Singh D, Agusti A, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Criner GJ, Frith P, Halpin DMG, Han M, Lopez Varela MV, Martinez F, Montes de Oca M, Papi A, Pavord ID, Roche N, Sin DD, Stockley R, Vestbo J, Wedzicha JA, Vogelmeier C. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019. Eur Respir J. 2019 May 18;53(5):1900164. doi: 10.1183/13993003.00164-2019. Print 2019 May.
PubMed 30846476
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04722224
- Acronym / sponsor ID
- reabilitar_DPOC_2
- Conditions
- COPD
- Keywords
- home-based pulmonary rehabilitation, exercise training, self-management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Polytechnic Institute of PortoUniversity, hospital or other
- Collaborators
- Nippon Gases Portugal
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 17 Jan 2024 (estimated)
- First posted
- 25 Jan 2021 (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.
This project aims to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation (PR) program (reabilitAR) in patients with chronic obstructive pulmonary disease (COPD). It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure).
Patients will be recruited at hospitals. Sociodemographic, anthropometric, and comorbidities; vital signs and peripheral oxygen saturation; symptoms (dyspnea, fatigue); lung function; functional capacity; exercise capacity; the impact of the disease, balance, and cognitive function will be collected before the reabilitAR program. Additionally, health care utilization will be registered. Then, patients will be entered into the reabilitAR program (12 weeks). The intervention consists in a strategic mixture of home visits and phone calls. The program includes exercise training and the self-management educational program Living Well with COPD. After 12 weeks all outcome measures will be reassessed.
It is expected that the home-based approach will express benefits and reflect the concerns to provide appropriate responses to the patient's needs by increasing access to PR.
Detailed description
The World Health Organization (WHO) indicates that hundreds of millions of people worldwide are affected by chronic respiratory diseases (CRD), including chronic obstructive pulmonary disease (COPD). Pulmonary rehabilitation (PR) is an essential component in the management of CRD with the aim to improve patients' exercise and functional capacity and psychological condition with long-term adherence to health-enhancing behaviors, including exercise training and self-management skills.
However, despite the well-known evidence, this service is mostly underutilized due to poor accessibility, with only 1% of worldwide availability of PR services for COPD patients. Thus, is important to undertake actions that improve access to and delivery of PR services for suitable patients. One of the strategies in the international guidelines is the creation of new models of programs, where a home-based approach is indicated.
The aim of this project is to assess the short-term effectiveness and responsiveness of a home-based pulmonary rehabilitation program (reabilitAR) in patients with COPD. It is also an aim to establish the minimal clinically important differences for PR in patients with COPD for a novel incremental step test (exercise capacity outcome measure).
The plan is to recruit the maximum of patients with COPD via clinicians at hospitals. This study will enroll adult patients with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Patients will be referred by pulmonologists, from medical consultation in hospitals and clinics in Portugal. With the referral, it is expected that the medical doctor explains the goal and benefits of PR. Eligible patients will be contacted by the reabilitAR team, for additional questions and to begin the integration process.
Sociodemographic, anthropometric, and comorbidities; vital signs and peripheral oxygen saturation; symptoms (dyspnea, fatigue); lung function; functional capacity; exercise capacity; the impact of the disease, balance, and cognitive function will be collected before the reabilitAR program. Additionally, health care utilization will be registered.
The program consists in home visits for the exercise training and the self-management sessions, and motivational phone-calls including the follow-up of the clinical condition, the progression of exercise training, including a total of 14 home visits, with more visits in the first two weeks of the program (4 visits). From the third week, one visit will be replaced by a phone call, for a total of 10 phone calls.
After 12 weeks all outcome measures will be reassessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Home-based pulmonary rehabilitation | Experimental | Other: Home-based pulmonary rehabilitationPatients will be treated for 12 weeks. The intervention consists in a strategic mixture of home visits and phone calls. The program includes exercise training and the self-management educational program Living Well with COPD. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD based on the GOLD criteria - postbronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <70%;
- Electrocardiogram (ECG) record at rest;
- Written informed consent form;
Key exclusion criteria (2 listed)
- Presence of any clinical condition that does not allow the participants to a home-based PR program, such as, significant cardiovascular (e.g. symptomatic ischaemic cardiac disease), neurological (e.g. neuromuscular dystrophy disease), or presence of musculoskeletal disease;
- Signs of cognitive impairment (e.g. dementia).
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 |
|---|---|---|
| Home-based pulmonary rehabilitationThe reabilitAR program includes the self-management educational program Living Well with COPD. The exercise training will include endurance, resistance/strength, flexibility and balance training. | Other | Intervention: Home-based pulmonary rehabilitation |
Primary outcome
Change from baseline number of steps (incremental step test) at 12 weeks
Time frame: At baseline and up to 12 weeks
The incremental step test will be used to assess exercise capacity
8 secondary outcomes
Change from baseline number of repetitions (1-minute sit-to-stand test) at 12 weeks
Time frame: At baseline and up to 12 weeks
Change from baseline score of CAT at 12 weeks
Time frame: At baseline and up to 12 weeks
Change from baseline score of dyspnea at 12 weeks
Time frame: At baseline and up to 12 weeks
Change from baseline score of fatigue at 12 weeks
Time frame: At baseline and up to 12 weeks
Change from baseline score of London Chest Activities of Daily Living at 12 weeks
Time frame: At baseline and up to 12 weeks
Change from baseline score of Hospital Anxiety and Depression Scale at 12 weeks
Time frame: At baseline and up to 12 weeks
Number of exacerbations
Time frame: Up to 12 weeks
Change from baseline score of mMRC at 12 weeks
Time frame: At baseline and up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- 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 26623686Rochester CL, Vogiatzis I, Holland AE, Lareau SC, Marciniuk DD, Puhan MA, Spruit MA, Masefield S, Casaburi R, Clini EM, Crouch R, Garcia-Aymerich J, Garvey C, Goldstein RS, Hill K, Morgan M, Nici L, Pitta F, Ries AL, Singh SJ, Troosters T, Wijkstra PJ, Yawn BP, ZuWallack RL; ATS/ERS Task Force on Policy in Pulmonary Rehabilitation. An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1373-86. doi: 10.1164/rccm.201510-1966ST.
- Background: PubMed 28244799Bui KL, Nyberg A, Maltais F, Saey D. Functional Tests in Chronic Obstructive Pulmonary Disease, Part 1: Clinical Relevance and Links to the International Classification of Functioning, Disability, and Health. Ann Am Thorac Soc. 2017 May;14(5):778-784. doi: 10.1513/AnnalsATS.201609-733AS.
- Background: PubMed 28244801Bui KL, Nyberg A, Maltais F, Saey D. Functional Tests in Chronic Obstructive Pulmonary Disease, Part 2: Measurement Properties. Ann Am Thorac Soc. 2017 May;14(5):785-794. doi: 10.1513/AnnalsATS.201609-734AS.
- Background: PubMed 18177782Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008 Feb;61(2):102-9. doi: 10.1016/j.jclinepi.2007.03.012. Epub 2007 Aug 3.
- Background: PubMed 30846476Singh D, Agusti A, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Criner GJ, Frith P, Halpin DMG, Han M, Lopez Varela MV, Martinez F, Montes de Oca M, Papi A, Pavord ID, Roche N, Sin DD, Stockley R, Vestbo J, Wedzicha JA, Vogelmeier C. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019. Eur Respir J. 2019 May 18;53(5):1900164. doi: 10.1183/13993003.00164-2019. Print 2019 May.
- Individual participant dataSharing planned: No
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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.
Rui A Vilarinho, Master principal investigator
School of Health, Polytechnic Institute of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based pulmonary rehabilitation in people with COPD, run by Polytechnic Institute of Porto at 1 site in Portugal.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Jan 2024. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui A Vilarinho, Master (222 061 000 ext. +351, ruivilarinho1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline number of steps (incremental step test) at 12 weeks (time frame: At baseline and up to 12 weeks). 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 NCT04722224, which also lists 6 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 19 Jan 2024.