Chronic Obstructive Pulmonary Disease (COPD)CoNSPiRENCT02917915
The CaNadian Standardized Pulmonary Rehabilitation Efficacy Trial
A study testing Canadian Standardized PR and Traditional PR in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Alberta at 1 site in Canada.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, and comprehensive intervention for COPD patients that includes patient assessment, exercise training, and self-management education to promote… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Canadian Standardized PR and Traditional PR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Dec 2021
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be enrolled into pulmonary rehabilitation within our affiliated PR sites, or in satellite Tele-health program, with a diagnosis of COPD confirmed by post-bronchodilator forced expiratory volume in 1 second by forced vital capacity (FEV1/FVC) ratio of less than 0.7.
- Patients must be able to read and communicate in English or French.
Who cannot join
- Patients enrolled into pulmonary rehabilitation with a diagnosis other than COPD will be excluded.
- Patients with cognitive impairments who are unable to accurately complete questionnaires will also be excluded.
- As part of standard rehabilitation referral procedures, all patients must be ambulatory and not have unstable cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, and comprehensive intervention for COPD patients that includes patient assessment, exercise training, and self-management education to promote behavior changes. PR has been shown to be the most effective strategy to improve clinical health outcomes, and is now considered to be a standard of care intervention for individuals with COPD who remain symptomatic despite optimal drug therapies. Despite considerable evidence supporting the effectiveness of PR at enhancing clinical outcomes, it is unclear if PR influences the behaviors that promote COPD management (i.e., physical activity, medication adherence, self-managing exacerbations).
In collaboration with the local clinical staff as well as national colleagues and the Canadian Thoracic Society, a new national pulmonary rehabilitation program has been co-developed that is designed to increase physical activity, medication adherence, and skills to help manage chronic lung diseases. The new program aims to increase people's confidence and autonomy for performing disease-management behaviors, and has been designed to be more effective at increasing physical activity, medication adherence, and disease management skills than previous pulmonary rehabilitation programs. The program is designed to be delivered within different settings of practice, including traditional PR centers, satellite sites (i.e., sites that are remote from the major institutions),with the use of Tele-health and web-based resources, and primary care medical centers. The effectiveness of the new Standardized Canadian PR program will be assessed relative to the traditional PR program. This trial is an important step towards establishing the necessary evidence that will then enable us to work on dissemination and implementation of this new standardized PR program across the country.
Read the detailed description
Phase 1: The implementation of the new Canadian Standardized PR program "Real life project" will be done after evaluating the existing pulmonary rehabilitation program in each of the four sites (G.F. MacDonald Centre for Lung Health, Mount Sinai Hospital, Montreal Chest Institute and West Park Health Care Centre). This will serve as pilot testing of the new pulmonary rehabilitation program to identify problems, adapt solution and improve the program, its content and delivery.
Phase 2: A randomized parallel-controlled trial (RPCT) will also be implemented in one site at the G.F. MacDonald Centre for Lung Health. Entire PR classes will be block randomized according to a random numbers table to receive usual care (traditional PR) or the new Canadian Standardized PR program. Several rural Tele-health sites that participate in PR via the G.F. MacDonald Centre for Lung Health will also be included and randomized as well. Both groups will be exposed to the same exercise training component. The two groups will be exposed to different education components (described in detail elsewhere). The effectiveness of the new Canadian Standardized PR program (experimental group) will be evaluated relative to the Traditional PR program (active comparator group) in terms of clinical, behavioural, and psychological outcomes.
Primary Objective: To determine if the new Canadian Standardized PR program delivered in-person and in satellites sites with the support of Tele-health improves and maintains specific self-management behaviors after rehabilitation more than the traditional PR program.
Primary Outcome: Physical activity (in steps-per day as measured by Fitbit®) Secondary Outcomes: i) Medication adherence (measured by pharmacy refills); ii) exacerbation recognition and prompt decision-making (diary \& phone calls).
Secondary Objectives: To determine if the new Canadian Standardized PR program improves predisposing factors of behavior change (knowledge, self-determination theory constructs such as motivation, and self-efficacy) following rehabilitation more than the Traditional PR program and if there is variation according to the method of delivering the program, i.e., via Tele-health technology vs in person.
To determine if the new Canadian Standardized PR program results in greater improvement of clinical outcomes (exercise capacity, health status) and health service use (hospital admissions) following completion of rehabilitation compared to the Traditional PR program.
Statistical Methods: Analysis for determining the potential benefit of the new Canadian Standardized PR program: Repeated measures ANOVAS will be conducted to evaluate changes over PR in behavioral outcomes (physical activity, medication adherence, exacerbation adherence), predisposing behavior change outcomes (self-efficacy, knowledge, self-determination theory constructs), and clinical outcomes (quality of life, exercise tolerance) between the Traditional PR group compared to the new Canadian Standardized PR group.
Patients' adherence to action plan and regular medication, self-efficacy, symptoms/health: After carefully examining data for distribution (and transforming if warranted), the investigators will first calculate the proportion (and 95% CI) of patients who initiate their action plan, including seeking treatment and increasing medications as appropriate within 48 hours of symptom onset. In the case of multiple exacerbations, only the first instance will be used. A separate analysis will be done for multiple exacerbations, to account for patient variables. The investigators will explore secondary objectives by evaluating changes over time in all patients in adherence to medication, self-efficacy, symptoms and, health related quality of life. Regression analyses will be used to explore changes in these outcomes while controlling for the effects of potential covariates and confounders such as baseline respiratory status, age, sex, disease severity, comorbidities and smoking status. The investigators will calculate means or proportions for acceptability to providers and resource use.
Sample Size Determination: The investigators anticipate a sample of 200 COPD patients (100 in each group), with 40 of those patients participating in rural sites by Tele-health. Sample size calculations are based on evaluating change in the primary outcome - physical activity as measured by steps per day - between the Traditional PR and new Canadian Standardized PR groups. A literature search indicated that Traditional PR seems to have a small to negligible effect on COPD patients' physical activity levels. Given that the new Canadian Standardized program is designed to specifically target predisposing factors of behavior change, the investigators anticipate a medium effect size increase in physical activity compared to the usual care program. In order to detect a medium effect size, with power = .80, and alpha = .05, the investigators will be recruiting 100 COPD patients per group (G*Power 3).
Data Handling and Record Keeping: Data will be collected and stored in a central Redcap database. Patients will all have a unique study code number, which will be the only unique identifier included within the Redcap database.
- Being tested
- Canadian Standardized PR, Traditional PR
- Keywords
- COPD, Emphysema, Chronic Bronchitis, Pulmonary rehabilitation, Lung Diseases, Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canadian Standardized PROther
Patients attend pulmonary rehabilitation (PR) 3 days per week for 6 weeks or 2 days per week for 8 weeks. Patients receive 2 hours of exercise training (aerobic and resistance) and 1 hour of education designed to promote self-management. In this intervention patients will receive the New Canadian Standardized PR educational approach (experimental).
Traditional PROther
Patients attend pulmonary rehabilitation (PR) 3 days per week for 6 weeks or 2 days per week for 8 weeks. Patients receive 2 hours of exercise training (aerobic and resistance) and 1 hour of education designed to promote self-management. In this intervention patients will receive the Traditional PR education approach (active comparator).
| Study group | Role | What they receive |
|---|---|---|
| New Canadian Standardized PR | Experimental | * Education Content: exercise, living well with chronic lung disease, breathing management, conserving energy, pulmonary medications, inhaler devices, integrating exercise in your life, management of respiratory infections, management of aggravating environmental factors, management of stress \& anxiety, nutrition, leisure \& travel, getting a good night's sleep, enjoying intimacy, living in a smoke-free environment, integrating long-term oxygen into your life, keeping a healthy lifestyle.
* Delivery style: During group sessions patients engage in active, participatory-based learning of program content. Workbooks are available. During one-on-one interactions motivational communication style (asking for permission before providing information, using open questions, etc.) is used. Receives: Other: Canadian Standardized PR |
| Traditional PR | Active comparator | * Education Content: Exercise, anatomy, pulmonary diseases, healthier breathing, pulmonary medications, pulmonary devices, exercise action plan, allergies \& pulmonary function tests, health and air quality, healthier eating, travel, stress management \& relaxation, tips to remember/summary of content.
* Delivery style: During group sessions, patients engage in passive learning of program content delivered in a lecture-style approach. Patients also receive one-on-one education regarding: dyspnea management/pacing, inhaler technique, exercise maintenance. Receives: Other: Traditional PR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity assessed as steps per day as evaluated by Fitbit
Measured: Change from baseline physical activity to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation
Secondary outcomes (2)
Patient adherence to exacerbation action plan
Measured: 6 months after rehabilitation has ended
Medication adherence assessed by pharmacy refill records
Measured: 6 months after rehabilitation has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2019
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, University of Toronto, Université de Sherbrooke
- Responsible party
- Principal investigator, Michael Stickland, University of Alberta
- Investigators
- Michael K Stickland, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917915
- Sponsor's protocol ID
- Pro00066560
- Acronym
- CoNSPiRE
- Status last verified
- Apr 2022
- First submitted
- 23 Sep 2016
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Selzler AM, Jourdain T, Wald J, Sedeno M, Janaudis-Ferreira T, Goldstein R, Bourbeau J, Stickland MK. Evaluation of an Enhanced Pulmonary Rehabilitation Program: A Randomized Controlled Trial. Ann Am Thorac Soc. 2021 Oct;18(10):1650-1660. doi: 10.1513/AnnalsATS.202009-1160OC.
PubMed 34004123
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CaNadian Standardized Pulmonary Rehabilitation Efficacy Trial
- ClinicalTrials.gov ID
- NCT02917915
- Acronym / sponsor ID
- CoNSPiRE / Pro00066560
- Keywords
- COPD, Emphysema, Chronic Bronchitis, Pulmonary rehabilitation, Lung Diseases, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- McGill University, University of Toronto, Université de Sherbrooke
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 28 Sep 2016 (estimated)
- 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.
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease primarily caused by smoking. Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, and comprehensive intervention for COPD patients that includes patient assessment, exercise training, and self-management education to promote behavior changes. PR has been shown to be the most effective strategy to improve clinical health outcomes, and is now considered to be a standard of care intervention for individuals with COPD who remain symptomatic despite optimal drug therapies. Despite considerable evidence supporting the effectiveness of PR at enhancing clinical outcomes, it is unclear if PR influences the behaviors that promote COPD management (i.e., physical activity, medication adherence, self-managing exacerbations).
In collaboration with the local clinical staff as well as national colleagues and the Canadian Thoracic Society, a new national pulmonary rehabilitation program has been co-developed that is designed to increase physical activity, medication adherence, and skills to help manage chronic lung diseases. The new program aims to increase people's confidence and autonomy for performing disease-management behaviors, and has been designed to be more effective at increasing physical activity, medication adherence, and disease management skills than previous pulmonary rehabilitation programs. The program is designed to be delivered within different settings of practice, including traditional PR centers, satellite sites (i.e., sites that are remote from the major institutions),with the use of Tele-health and web-based resources, and primary care medical centers. The effectiveness of the new Standardized Canadian PR program will be assessed relative to the traditional PR program. This trial is an important step towards establishing the necessary evidence that will then enable us to work on dissemination and implementation of this new standardized PR program across the country.
Detailed description
Phase 1: The implementation of the new Canadian Standardized PR program "Real life project" will be done after evaluating the existing pulmonary rehabilitation program in each of the four sites (G.F. MacDonald Centre for Lung Health, Mount Sinai Hospital, Montreal Chest Institute and West Park Health Care Centre). This will serve as pilot testing of the new pulmonary rehabilitation program to identify problems, adapt solution and improve the program, its content and delivery.
Phase 2: A randomized parallel-controlled trial (RPCT) will also be implemented in one site at the G.F. MacDonald Centre for Lung Health. Entire PR classes will be block randomized according to a random numbers table to receive usual care (traditional PR) or the new Canadian Standardized PR program. Several rural Tele-health sites that participate in PR via the G.F. MacDonald Centre for Lung Health will also be included and randomized as well. Both groups will be exposed to the same exercise training component. The two groups will be exposed to different education components (described in detail elsewhere). The effectiveness of the new Canadian Standardized PR program (experimental group) will be evaluated relative to the Traditional PR program (active comparator group) in terms of clinical, behavioural, and psychological outcomes.
Primary Objective: To determine if the new Canadian Standardized PR program delivered in-person and in satellites sites with the support of Tele-health improves and maintains specific self-management behaviors after rehabilitation more than the traditional PR program.
Primary Outcome: Physical activity (in steps-per day as measured by Fitbit®) Secondary Outcomes: i) Medication adherence (measured by pharmacy refills); ii) exacerbation recognition and prompt decision-making (diary \& phone calls).
Secondary Objectives: To determine if the new Canadian Standardized PR program improves predisposing factors of behavior change (knowledge, self-determination theory constructs such as motivation, and self-efficacy) following rehabilitation more than the Traditional PR program and if there is variation according to the method of delivering the program, i.e., via Tele-health technology vs in person.
To determine if the new Canadian Standardized PR program results in greater improvement of clinical outcomes (exercise capacity, health status) and health service use (hospital admissions) following completion of rehabilitation compared to the Traditional PR program.
Statistical Methods: Analysis for determining the potential benefit of the new Canadian Standardized PR program: Repeated measures ANOVAS will be conducted to evaluate changes over PR in behavioral outcomes (physical activity, medication adherence, exacerbation adherence), predisposing behavior change outcomes (self-efficacy, knowledge, self-determination theory constructs), and clinical outcomes (quality of life, exercise tolerance) between the Traditional PR group compared to the new Canadian Standardized PR group.
Patients' adherence to action plan and regular medication, self-efficacy, symptoms/health: After carefully examining data for distribution (and transforming if warranted), the investigators will first calculate the proportion (and 95% CI) of patients who initiate their action plan, including seeking treatment and increasing medications as appropriate within 48 hours of symptom onset. In the case of multiple exacerbations, only the first instance will be used. A separate analysis will be done for multiple exacerbations, to account for patient variables. The investigators will explore secondary objectives by evaluating changes over time in all patients in adherence to medication, self-efficacy, symptoms and, health related quality of life. Regression analyses will be used to explore changes in these outcomes while controlling for the effects of potential covariates and confounders such as baseline respiratory status, age, sex, disease severity, comorbidities and smoking status. The investigators will calculate means or proportions for acceptability to providers and resource use.
Sample Size Determination: The investigators anticipate a sample of 200 COPD patients (100 in each group), with 40 of those patients participating in rural sites by Tele-health. Sample size calculations are based on evaluating change in the primary outcome - physical activity as measured by steps per day - between the Traditional PR and new Canadian Standardized PR groups. A literature search indicated that Traditional PR seems to have a small to negligible effect on COPD patients' physical activity levels. Given that the new Canadian Standardized program is designed to specifically target predisposing factors of behavior change, the investigators anticipate a medium effect size increase in physical activity compared to the usual care program. In order to detect a medium effect size, with power = .80, and alpha = .05, the investigators will be recruiting 100 COPD patients per group (G*Power 3).
Data Handling and Record Keeping: Data will be collected and stored in a central Redcap database. Patients will all have a unique study code number, which will be the only unique identifier included within the Redcap database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Canadian Standardized PR | Experimental | Other: Canadian Standardized PR* Education Content: exercise, living well with chronic lung disease, breathing management, conserving energy, pulmonary medications, inhaler devices, integrating exercise in your life, management of respiratory infections, management of aggravating environmental factors, management of stress \& anxiety, nutrition, leisure \& travel, getting a good night's sleep, enjoying intimacy, living in a smoke-free environment, integrating long-term oxygen into your life, keeping a healthy lifestyle. * Delivery style: During group sessions patients engage in active, participatory-based learning of program content. Workbooks are available. During one-on-one interactions motivational communication style (asking for permission before providing information, using open questions, etc.) is used. |
| Traditional PR | Active comparator | Other: Traditional PR* Education Content: Exercise, anatomy, pulmonary diseases, healthier breathing, pulmonary medications, pulmonary devices, exercise action plan, allergies \& pulmonary function tests, health and air quality, healthier eating, travel, stress management \& relaxation, tips to remember/summary of content. * Delivery style: During group sessions, patients engage in passive learning of program content delivered in a lecture-style approach. Patients also receive one-on-one education regarding: dyspnea management/pacing, inhaler technique, exercise maintenance. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be enrolled into pulmonary rehabilitation within our affiliated PR sites, or in satellite Tele-health program, with a diagnosis of COPD confirmed by post-bronchodilator forced expiratory volume in 1 second by forced vital capacity (FEV1/FVC) ratio of less than 0.7.
- Patients must be able to read and communicate in English or French.
Key exclusion criteria (3 listed)
- Patients enrolled into pulmonary rehabilitation with a diagnosis other than COPD will be excluded.
- Patients with cognitive impairments who are unable to accurately complete questionnaires will also be excluded.
- As part of standard rehabilitation referral procedures, all patients must be ambulatory and not have unstable cardiovascular disease.
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 |
|---|---|---|
| Canadian Standardized PRPatients attend pulmonary rehabilitation (PR) 3 days per week for 6 weeks or 2 days per week for 8 weeks. Patients receive 2 hours of exercise training (aerobic and resistance) and 1 hour of education designed to promote self-management. In this intervention patients will receive the New Canadian Standardized PR educational approach (experimental). | Other | New Canadian Standardized PR |
| Traditional PRPatients attend pulmonary rehabilitation (PR) 3 days per week for 6 weeks or 2 days per week for 8 weeks. Patients receive 2 hours of exercise training (aerobic and resistance) and 1 hour of education designed to promote self-management. In this intervention patients will receive the Traditional PR education approach (active comparator). | Other | Traditional PR |
Primary outcome
Physical activity assessed as steps per day as evaluated by Fitbit
Time frame: Change from baseline physical activity to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation
2 secondary outcomes
Patient adherence to exacerbation action plan
Time frame: 6 months after rehabilitation has ended
Medication adherence assessed by pharmacy refill records
Time frame: 6 months after rehabilitation has ended
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 7 Apr 2022.
- Derived from this study: PubMed 34004123Selzler AM, Jourdain T, Wald J, Sedeno M, Janaudis-Ferreira T, Goldstein R, Bourbeau J, Stickland MK. Evaluation of an Enhanced Pulmonary Rehabilitation Program: A Randomized Controlled Trial. Ann Am Thorac Soc. 2021 Oct;18(10):1650-1660. doi: 10.1513/AnnalsATS.202009-1160OC.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Michael K Stickland, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canadian Standardized PR and Traditional PR in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Alberta at 1 site in Canada.
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 3 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 7 Apr 2022. 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 Canada. 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 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?
Physical activity assessed as steps per day as evaluated by Fitbit (time frame: Change from baseline physical activity to the end of rehabilitation (6-8 weeks) and 6 months post-rehabilitation). 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 NCT02917915, which also lists 1 linked publication.
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 7 Apr 2022.