CancerPiONEeRNCT04666558
Heal-Me Personalized Online Nutrition and Exercise Routines
A study testing Exercise & Nutrition in people with Cancer and Lung Diseases, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung Diseases, Liver Diseases
- What is being tested?
- Exercise & Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2020to 31 Aug 2022
- 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
- ≥ 18 years of age
- In one of the following 3 disease groups:
- Cancer survivor who has completed treatment or is receiving maintenance therapy
- Patient who is currently post-transplantation from liver or lung transplantation
- Patient with chronic lung disease who may or may not be listed for organ transplantation
- Previous enrolment in exercise rehabilitation program (i.e. rehabilitation "graduate")
- Access to an Internet connected device with video and audio capabilities
Who cannot join
- Compassionate care
- Unsafe to participate in a virtual exercise program
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heal-Me PiONEeR (Personalized Online Nutrition and Exercise Routines) - Reconnecting Vulnerable Outpatients With Multidisciplinary Care - a Randomized Controlled Trial Assessing 3 Levels of Online Programming in the Time of COVID
The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease.
Participants will be randomized to one of three groups: (i) standard care, (ii) a personnel-light app-based intervention, (iii) a personnel-intensive app-based intervention. Participants randomized to standard care will receive exercise and nutrition resources as well as a Garmin watch. Participants in the experimental groups will receive standard care, plus a 12-week multidisciplinary app-based personalized program involving 12 weeks of exercise programming and 10-weeks of nutrition programming. Participants in study group 3 will receive additional one-on-one care.
Read more
The Research Ethics Board at the University of Alberta has approved this study. The protocol will measure patient-related outcome measures including physical function, quality of life, social isolation, and anxiety, as well as measures of acceptability and cost. 216 participants will take part in this study (n=72 per arm).
Analyses: fitness testing and patient-reported outcomes will be administered before and after the intervention. Fitness and patient-reported outcomes will be compared using linear mixed models with random effects. App acceptability will be compared between groups using Chi-Square.
Read the detailed description
INTRODUCTION:
COVID-19 related social distancing have a profound impact on vulnerable people living with chronic conditions, including cancer and organ failure. Pre-pandemic, many of these patients relied on and benefited from multidisciplinary supports and structured programming to maintain well-being and function. Many of these in-person supports are not currently available, which has disconnected these patients from the care they need to stay well.
Virtual modalities are a promising solution that allow multidisciplinary programs (i.e. exercise and nutrition) to continue to deliver support for these patients when social distancing doesn't allow these programs to run in-person. However, it's currently unclear whether virtual programming is acceptable in these populations, and what level of support is best in terms of benefits and costs.
The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease.
OBJECTIVES:
- As compared to control, assess the impact of a 12-week virtual exercise and nutrition program (delivered at 2 levels of support) on: physical function and mental health outcomes.
- As compared to the modeled costs of in-person programming, assess the cost of a 12-week virtual exercise and nutrition program (delivered at 2 levels of support).
- Assess the acceptability of the virtual exercise and nutrition programming to patients and members of the study team who deliver the intervention.
METHODS:
This is a mixed-methods, 12-week randomized controlled trial with randomization to one of three study groups with increasing virtual multidisciplinary support for outpatients. Participants will include people living with one of the following three chronic conditions: cancer, lung disease, or lung or liver disease (post-transplantation).
Group 1 - The standard of care response to COVID. Educational materials will be provided to patients via email. As needed, the package will include a combination of personalized exercises, disease-tailored tips for healthy eating and COVID precautions. Ad hoc telephone or virtual contact with patients will be at the providers' discretion.
Group 2 - An app-based, "personnel-light" approach to virtual care with a focus on support through group-based interactions with the Trainers and other participants during live group exercise and nutrition classes (~3/week). The patient's personalized 12-week home based exercise program will be enabled in the app after a baseline exercise specialist appointment and the 10-week nutrition program will be enabled at week 3 after a dietitian assessment in week 2. The home programs will auto-progress.
Group 3 - An app-based, "personnel-intensive" approach. In addition to Group 2 features, patient interaction with Trainers will be via live group classes AND 1-to-1 sessions: seven 1-to-1 consultations with an exercise specialist and three 1-to-1 consultations with a dietitian to review progress and goals and make any necessary modifications to programming.
OUTCOMES \& ANALYSES:
All analyses adhere to the intention-to-treat-principle (ITT). Fitness assessments and patient-reported outcomes will be collected at baseline and 12-weeks. Primary and secondary outcomes from these data will be analyzed using linear mixed models with random effects. Adherence and app acceptability (survey) will be compared between groups using the chi-square. Costs of each level of support will be compared with the cost of in-person programming using a publicly funded provincial payer perspective and will be presented in the Net Benefit framework.
Interviews will be conducted with participants, caregivers, and program instructors to determine program acceptability and barriers and facilitators. Inductive content analysis will be used to analyze qualitative data.
- Conditions
- Cancer, Lung Diseases, Liver Diseases
- Being tested
- Exercise & Nutrition
- Keywords
- Exercise, Nutrition, Chronic Disease, Virtual
- Medical subject headings
- Neoplasms, Lung Diseases, Liver Diseases, Motor Activity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise & NutritionOther
App-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking.
Exercise & NutritionOther
App-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking. Additional one-one-one exercise and nutrition support is provided too.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | The standard of care response to COVID. Educational materials will be provided to patients via email. The package will include a combination of personalized exercises, and nutrition information for healthy eating. Participants will also receive a Garmin watch to track their activity over the intervention. |
| App-Based, Personnel-Light Care | Experimental | An app-based, "personnel-light" approach to virtual care with a focus on support through group-based interactions with the Trainers, Dietitians and other participants. The patient's personalized 12-week home based exercise program will be enabled in the app after a baseline exercise specialist appointment. The 10-week nutrition program will be enabled at week 3 after a virtual dietitian assessment in week 2 (~1 hour). The home programs will auto-progress. Participants will also receive a Garmin watch to track their activity over the intervention. Receives: Other: Exercise & Nutrition |
| App-Based, Personnel-Intensive Care | Experimental | An app-based, "personnel-intensive" approach to virtual care with support through a combination of group-based interactions with Trainers, Dietitians and other participants, as well as one-on-one support with Exercise Trainers and Dietitians. In addition to Group 2 features, patient interaction with Trainers will be via live group classes AND 1-to-1 sessions: up to seven 1-to-1 consultations with an exercise specialist and three 1-to-1 consultations with a dietitian to review progress and goals and make any necessary modifications to programming. Participants will also receive a Garmin watch to track their activity over the intervention. Receives: Other: Exercise & Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Functional Scale (LEFS)
The difference in the pre- vs post-intervention change in LEFS score between groups (score range: 0-80, higher scores indicate higher function)
Measured: 12 Weeks
Secondary outcomes (10)
Upper Extremity Functional Index (UEFI)
The difference in the pre- vs post-intervention change in UEFI score between groups (score range: 0-80, higher scores indicate higher function)
Measured: 12 weeks
Timed Sit-to-Stand (60 & 30 seconds)
The difference in the pre- vs post-intervention change in # of repetitions completed over the Timed Sit-to-Stand between groups
Measured: 12 Weeks
Timed One-Legged Stance
The difference in the pre- vs post-intervention change in Timed One-Legged Stance between groups
Measured: 12 Weeks
2-Minute Step Test (2MST)
The difference in the pre- vs post-intervention change in the # of steps completed in the 2MST between groups
Measured: 12 Weeks
Sit-and-Reach
The difference in the pre- vs post-intervention change in the sit-and-reach distance between groups
Measured: 12 Weeks
Step Count & Activity Minutes
The difference in the pre- vs post-intervention change in step count and activity minutes (Garmin watch) between groups
Measured: 12 Weeks
Overall Well-Being (The World Health Organization-5 [WHO-5] Well-Being Index)
The difference in the pre- vs post-intervention change in The World Health Organization-5 (WHO-5) Well-Being Index between groups (score range: 0-25, higher scores indicate higher well-being)
Measured: 12 Weeks
Resilience (10-Item Connor Davidson Resilience Scale)
The difference in the pre- vs post-intervention change in resilience, as measures by the 10-Item Connor Davidson Resilience Scale, between groups (score range: 0-40, higher scores indicate higher resilience)
Measured: 12 Weeks
General health-related quality of life (36-Item Short Form Survey [SF-36])
The difference in the pre- vs post-intervention change in health-related quality of life, as measured by the SF-36, between groups (score range: 0-100, higher scores indicate a more favorable health state)
Measured: 12 Weeks
General health-related quality of life (5-Level EQ-5D [EQ-5D-5L])
The difference in the pre- vs post-intervention change in health-related quality of life, as measured by the EQ-5D-5L, between groups (visual analogue score range: 0-100, higher scores indicate a more favorable health state)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start30 Nov 2020
- Primary completion17 Dec 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666558
- Sponsor's protocol ID
- Pro00103715
- Acronym
- PiONEeR
- Status last verified
- Jul 2022
- First submitted
- 30 Nov 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tandon P, Ismond KP, Purdy G, Cruz C, Etruw E, Suderman K, Hyde A, Stickland M, Spence JC, Lien DC, Bhanji R, Prado CM, Miguel-Cruz A, Joy AA, Yaskina M, McNeely ML. Acceptability and Effectiveness of a Fully Web-Based Nutrition and Exercise Program for Individuals With Chronic Disease During COVID-19: Randomized Controlled Trial. J Med Internet Res. 2025 Mar 24;27:e57537. doi: 10.2196/57537.
PubMed 40126542Tandon P, Purdy G, Ismond KP, Cruz C, Etruw E, Suderman K, Hyde A, Stickland M, Spence JC, Lien DC, Bhanji R, Prado CM, Cruz AM, Joy AA, Yaskina M, Round J, Harback K, Padwal R, McNeely ML. Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease. Contemp Clin Trials. 2022 Jul;118:106791. doi: 10.1016/j.cct.2022.106791. Epub 2022 May 13.
PubMed 35569753Cruz C, Prado CM, Punja S, Tandon P. Use of digital technologies in the nutritional management of catabolism-prone chronic diseases: A rapid review. Clin Nutr ESPEN. 2021 Dec;46:152-166. doi: 10.1016/j.clnesp.2021.10.020. Epub 2021 Nov 1.
PubMed 34857190
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heal-Me PiONEeR (Personalized Online Nutrition and Exercise Routines) - Reconnecting Vulnerable Outpatients With Multidisciplinary Care - a Randomized Controlled Trial Assessing 3 Levels of Online Programming in the Time of COVID
- ClinicalTrials.gov ID
- NCT04666558
- Acronym / sponsor ID
- PiONEeR / Pro00103715
- Conditions
- Cancer, Lung Diseases, Liver Diseases
- Keywords
- Exercise, Nutrition, Chronic Disease, Virtual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 14 Dec 2020 (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.
The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease.
Participants will be randomized to one of three groups: (i) standard care, (ii) a personnel-light app-based intervention, (iii) a personnel-intensive app-based intervention. Participants randomized to standard care will receive exercise and nutrition resources as well as a Garmin watch. Participants in the experimental groups will receive standard care, plus a 12-week multidisciplinary app-based personalized program involving 12 weeks of exercise programming and 10-weeks of nutrition programming. Participants in study group 3 will receive additional one-on-one care.
The Research Ethics Board at the University of Alberta has approved this study. The protocol will measure patient-related outcome measures including physical function, quality of life, social isolation, and anxiety, as well as measures of acceptability and cost. 216 participants will take part in this study (n=72 per arm).
Analyses: fitness testing and patient-reported outcomes will be administered before and after the intervention. Fitness and patient-reported outcomes will be compared using linear mixed models with random effects. App acceptability will be compared between groups using Chi-Square.
Detailed description
INTRODUCTION:
COVID-19 related social distancing have a profound impact on vulnerable people living with chronic conditions, including cancer and organ failure. Pre-pandemic, many of these patients relied on and benefited from multidisciplinary supports and structured programming to maintain well-being and function. Many of these in-person supports are not currently available, which has disconnected these patients from the care they need to stay well.
Virtual modalities are a promising solution that allow multidisciplinary programs (i.e. exercise and nutrition) to continue to deliver support for these patients when social distancing doesn't allow these programs to run in-person. However, it's currently unclear whether virtual programming is acceptable in these populations, and what level of support is best in terms of benefits and costs.
The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease.
OBJECTIVES:
- As compared to control, assess the impact of a 12-week virtual exercise and nutrition program (delivered at 2 levels of support) on: physical function and mental health outcomes.
- As compared to the modeled costs of in-person programming, assess the cost of a 12-week virtual exercise and nutrition program (delivered at 2 levels of support).
- Assess the acceptability of the virtual exercise and nutrition programming to patients and members of the study team who deliver the intervention.
METHODS:
This is a mixed-methods, 12-week randomized controlled trial with randomization to one of three study groups with increasing virtual multidisciplinary support for outpatients. Participants will include people living with one of the following three chronic conditions: cancer, lung disease, or lung or liver disease (post-transplantation).
Group 1 - The standard of care response to COVID. Educational materials will be provided to patients via email. As needed, the package will include a combination of personalized exercises, disease-tailored tips for healthy eating and COVID precautions. Ad hoc telephone or virtual contact with patients will be at the providers' discretion.
Group 2 - An app-based, "personnel-light" approach to virtual care with a focus on support through group-based interactions with the Trainers and other participants during live group exercise and nutrition classes (~3/week). The patient's personalized 12-week home based exercise program will be enabled in the app after a baseline exercise specialist appointment and the 10-week nutrition program will be enabled at week 3 after a dietitian assessment in week 2. The home programs will auto-progress.
Group 3 - An app-based, "personnel-intensive" approach. In addition to Group 2 features, patient interaction with Trainers will be via live group classes AND 1-to-1 sessions: seven 1-to-1 consultations with an exercise specialist and three 1-to-1 consultations with a dietitian to review progress and goals and make any necessary modifications to programming.
OUTCOMES \& ANALYSES:
All analyses adhere to the intention-to-treat-principle (ITT). Fitness assessments and patient-reported outcomes will be collected at baseline and 12-weeks. Primary and secondary outcomes from these data will be analyzed using linear mixed models with random effects. Adherence and app acceptability (survey) will be compared between groups using the chi-square. Costs of each level of support will be compared with the cost of in-person programming using a publicly funded provincial payer perspective and will be presented in the Net Benefit framework.
Interviews will be conducted with participants, caregivers, and program instructors to determine program acceptability and barriers and facilitators. Inductive content analysis will be used to analyze qualitative data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –The standard of care response to COVID. Educational materials will be provided to patients via email. The package will include a combination of personalized exercises, and nutrition information for healthy eating. Participants will also receive a Garmin watch to track their activity over the intervention. |
| App-Based, Personnel-Light Care | Experimental | Other: Exercise & NutritionAn app-based, "personnel-light" approach to virtual care with a focus on support through group-based interactions with the Trainers, Dietitians and other participants. The patient's personalized 12-week home based exercise program will be enabled in the app after a baseline exercise specialist appointment. The 10-week nutrition program will be enabled at week 3 after a virtual dietitian assessment in week 2 (~1 hour). The home programs will auto-progress. Participants will also receive a Garmin watch to track their activity over the intervention. |
| App-Based, Personnel-Intensive Care | Experimental | Other: Exercise & NutritionAn app-based, "personnel-intensive" approach to virtual care with support through a combination of group-based interactions with Trainers, Dietitians and other participants, as well as one-on-one support with Exercise Trainers and Dietitians. In addition to Group 2 features, patient interaction with Trainers will be via live group classes AND 1-to-1 sessions: up to seven 1-to-1 consultations with an exercise specialist and three 1-to-1 consultations with a dietitian to review progress and goals and make any necessary modifications to programming. Participants will also receive a Garmin watch to track their activity over the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years of age
- In one of the following 3 disease groups:
- Previous enrolment in exercise rehabilitation program (i.e. rehabilitation "graduate")
- Access to an Internet connected device with video and audio capabilities
Key exclusion criteria (3 listed)
- Compassionate care
- Unsafe to participate in a virtual exercise program
- Unable to provide informed consent
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 |
|---|---|---|
| Exercise & NutritionApp-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking. | Other | App-Based, Personnel-Light Care |
| Exercise & NutritionApp-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking. Additional one-one-one exercise and nutrition support is provided too. | Other | App-Based, Personnel-Intensive Care |
Primary outcome
Lower Extremity Functional Scale (LEFS)
Time frame: 12 Weeks
The difference in the pre- vs post-intervention change in LEFS score between groups (score range: 0-80, higher scores indicate higher function)
10 secondary outcomes
Upper Extremity Functional Index (UEFI)
Time frame: 12 weeks
Timed Sit-to-Stand (60 & 30 seconds)
Time frame: 12 Weeks
Timed One-Legged Stance
Time frame: 12 Weeks
2-Minute Step Test (2MST)
Time frame: 12 Weeks
Sit-and-Reach
Time frame: 12 Weeks
Step Count & Activity Minutes
Time frame: 12 Weeks
Overall Well-Being (The World Health Organization-5 [WHO-5] Well-Being Index)
Time frame: 12 Weeks
Resilience (10-Item Connor Davidson Resilience Scale)
Time frame: 12 Weeks
General health-related quality of life (36-Item Short Form Survey [SF-36])
Time frame: 12 Weeks
General health-related quality of life (5-Level EQ-5D [EQ-5D-5L])
Time frame: 12 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 4 Oct 2022.
- Derived from this study: PubMed 40126542Tandon P, Ismond KP, Purdy G, Cruz C, Etruw E, Suderman K, Hyde A, Stickland M, Spence JC, Lien DC, Bhanji R, Prado CM, Miguel-Cruz A, Joy AA, Yaskina M, McNeely ML. Acceptability and Effectiveness of a Fully Web-Based Nutrition and Exercise Program for Individuals With Chronic Disease During COVID-19: Randomized Controlled Trial. J Med Internet Res. 2025 Mar 24;27:e57537. doi: 10.2196/57537.
- Derived from this study: PubMed 35569753Tandon P, Purdy G, Ismond KP, Cruz C, Etruw E, Suderman K, Hyde A, Stickland M, Spence JC, Lien DC, Bhanji R, Prado CM, Cruz AM, Joy AA, Yaskina M, Round J, Harback K, Padwal R, McNeely ML. Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease. Contemp Clin Trials. 2022 Jul;118:106791. doi: 10.1016/j.cct.2022.106791. Epub 2022 May 13.
- Derived from this study: PubMed 34857190Cruz C, Prado CM, Punja S, Tandon P. Use of digital technologies in the nutritional management of catabolism-prone chronic diseases: A rapid review. Clin Nutr ESPEN. 2021 Dec;46:152-166. doi: 10.1016/j.clnesp.2021.10.020. Epub 2021 Nov 1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise & Nutrition in people with Cancer and Lung Diseases, 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 7 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 4 Oct 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?
Lower Extremity Functional Scale (LEFS) (time frame: 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 NCT04666558, which also lists 3 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 4 Oct 2022.