ExerciseNCT03991273
Testing the Implementation of Movement-to-Music in a Community Fitness Center and Blended Onsite and Teleexercise Class
A study testing Y-M2M© and B-M2M© in people with Exercise and Disability Physical, run by University of Alabama at Birmingham.
Trial summary
To prepare for a large scale-up study, the goal of this pilot implementation trial is to examine the feasibility of Movement-to-Music (M2M©) delivery mechanisms through two channels: 1) a group-based M2M© program conducted onsite at a local YMCA; and 2) a blended program that provides Y-M2M© and a home-based M2M©… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Exercise, Disability Physical
- What is being tested?
- Y-M2M© and B-M2M©
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2021to 20 Apr 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary diagnosis of head injury, stroke, MS, spinal cord injury, spina bifida, Parkinson's disease or cerebral palsy conferred by a physician and fits one of the three functional mobility groups (Groups I-III);
- between the ages of 19 to 70 yrs.;
- physician clearance to participate;
- willing to participate in an exercise program 3 times per week;
- conversant in and reads English.
Who cannot join
- participated in a similar intervention in the last 6 months;
- use of tobacco products in the last 6 months;
- cognitive impairment;
- active pressure ulcer;
- any contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines;
- visual acuity that prevents following a group exercise class;
- significant hearing impairment impeding ability to hear music to engage in exercise.
About this study
Official title: Testing the Implementation Efficacy of Movement-to-Music Delivered in a Community-Based Fitness Center and Blended Onsite and Home-based Group Teleexercise Class: A Mixed-Methods Pilot Study.
To prepare for a large scale-up study, the goal of this pilot implementation trial is to examine the feasibility of Movement-to-Music (M2M©) delivery mechanisms through two channels: 1) a group-based M2M© program conducted onsite at a local YMCA; and 2) a blended program that provides Y-M2M© and a home-based M2M© (B-M2M©) via videoconferencing. A key element of this pilot is to examine issues associated with participant-provider interactions, and to better understand the robustness of the technology to deliver a group-based (teleexercise) version of M2M© in the home setting.
Read the detailed description
There will be 4 phases to this study. In phase 1, the investigators will explore potential barriers and supports that may affect the delivery of M2M© at one YMCA facility through one-on-one interviews with YMCA staff that have been trained to conduct M2M©.
Phase 2 will include a quantitative monitoring phase. During this phase the 2 delivery mechanisms of M2M© (Y-M2M© and B-M2M©) will be evaluated through assessments of quantitative feasibility metrics before, during, and after the intervention. The intervention will include a convenient sample of 54 participants.
To expand on the findings from the previous quantitative phase, phase 3 will include post-intervention focus group interviews conducted separately for each stakeholder group: all 54 participants, M2M© trainers, research assistants involved with technical support, and YMCA staff that were involved with the project.
During phase 4 (the integrative phase), the researchers will compile the quantitative and qualitative findings for the three primary feasibility metrics (process, resource, and management). These findings will then be comprehensively analyzed by a review panel that will provide suggestions for improvement within each metric. The panel will then discuss the summative findings and vote towards acceptable or not acceptable feasibility.
The 12-week Y-M2M© intervention will be pilot tested at one YMCA facility in Birmingham, AL.The B-M2M© group will be provided with the flexibility of attending the same onsite classes at the YMCA facility as participants in the Y-M2M© group and will also be able to participate in group M2M© teleexercise classes at home that are conducted through Internet video conferencing.
The investigators will use a permuted block randomization design to ensure close balance between the arms across waves and to increase the unpredictability in the upcoming assignment and prevent inadvertent bias. The project statistician will generate the randomization list that will be provided to the project coordinator in sealed envelopes to conceal the allocation. Assessors (health and function assessments done at Lakeshore Foundation) will be blinded to participant assignment and allocation of the arm assignment will not be done until baseline testing and measures are collected.
Primary quantitative outcomes will include those related to process, resources, and management. In summary, these metrics will include measures of adherence, issues that arise with implementation and the efficiency to which they are resolved, and intervention fidelity between the delivery sites. Secondary quantitative outcomes will include estimates of variability in scientific outcomes (physical activity; quality of life; social participation; fitness Measures (cardiorespiratory fitness, muscle strength, lower extremity function; social cognitive theory constructs [Self-efficacy, Outcome expectations, Barriers, Social support]).
- Conditions
- Exercise, Disability Physical
- Being tested
- Y-M2M©, B-M2M©
- Keywords
- disability, disabilities, teleexercise, movement-to-music, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-M2M©Other
The Y-M2M© group will receive classes that will be delivered onsite at a YMCA facility. Movement-to-Music (M2M©) is an instructor-guided exercise program that is coupled with music to enhance strength, cardiorespiratory capacity, range of motion, and balance.
B-M2M©Other
The B-M2M© group will receive the same onsite M2M© classes as the Y-M2M© group, but they will also be provided with the option of performing home-based M2M© that will be delivered via videoconferencing.
| Study group | Role | What they receive |
|---|---|---|
| Y-M2M© | Experimental | a group-based M2M© program conducted onsite at a local YMCA Receives: Other: Y-M2M© |
| B-M2M© | Experimental | a blended program that provides Y-M2M© and a home-based M2M© via videoconferencing Receives: Other: Y-M2M©; Other: B-M2M© |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Foreseeable implementation barriers and supports as reported by YMCA trainers
Prior to conducting the intervention, the investigators will conduct interviews to qualitatively explore YMCA trainers' perceptions of organizational or system factors that can potentially facilitate the adoption of M2M© in YMCAs and tailor the M2M© delivery plan accordingly (using open-ended questions).
Measured: Pre-intervention (week 0)
Phase 2: Quantitative feasibility metric (Process outcome #1:Enrollment Rate)
Enrollment rate: the number of participants screened / total enrolled
Measured: Intervention (weeks 1-12)
Phase 2: Quantitative feasibility metric (Process outcome #2: Class Attendance)
Attendance to the exercise sessions: total number of sessions attended divided by the total 36 prescribed sessions
Measured: Intervention (weeks 1-12)
Phase 2: Quantitative feasibility metric (Process outcome #3: Attrition Rate)
Attrition rate: number of participants that withdraw from the intervention
Measured: Intervention (weeks 1-12)
Phase 2: Quantitative feasibility metric (Process outcome #4: Time to complete data collection)
Time to complete data collection: time in minutes required to complete data collection (average of both pre- and post-data collection visit times)
Measured: Intervention (weeks 1-12)
Phase 2: Quantitative feasibility metric (Process outcome #1: Technical difficulties with technology)
Technical difficulties with technology: Frequency of issues experienced by participants and trainers
Measured: Intervention (weeks 1-12)
Phase 2: Quantitative feasibility metric (Resource outcome #2: Resources required by the YMCA)
Resources required by the YMCA: # of items purchased for a YMCA M2M class
Measured: Intervention (weeks 1-12)
Phase 2: Quantitative feasibility metric (Management outcome #1: M2M fidelity between conditions)
M2M fidelity between conditions: the frequency of times a deviation from the protocol was observed for both the YMCA and Teleexercise classes.
Measured: Intervention (weeks 1-12)
Phase 2: Quantitative feasibility metric (Management outcome #2: Issues with data management)
Issues with data management: frequency of issues encountered
Measured: Intervention (weeks 1-12)
Phase 3: Qualitative interview exploring stakeholders' perceptions of intervention implementation
Focus group interviews will be conducted separately for each stakeholder group: all 54 participants, M2M© trainers, research assistants involved with technical support, and YMCA staff that were involved with the project. The semi-structured interviews will explore participants' perceptions regarding the intervention implementation process, resources, and management (using open-ended questions)
Measured: Post-Intervention (week 13)
Secondary outcomes (11)
Phase 2: Quantitative feasibility metric (Scientific outcome #1: Physical Activity)
Physical Activity: measured via the Godin Leisure-Time Exercise Questionnaire (total score and health-contribution score)
Measured: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome #2: Quality of life)
Quality of life: measured via the NIH PROMIS 10 Global Health Items (total score)
Measured: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome #3: Social participation)
Social participation: measured via the NIH PROMIS Ability to Participate in Social Roles and Activities
Measured: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 4: Self-Efficacy)
Self-Efficacy: measured via the Exercise Self-Efficacy Scale (total score)
Measured: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 5: Outcome expectations)
Outcome expectations: measured via the Multidimensional Outcomes Expectations for Exercise Scale (total score)
Measured: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 6: Barriers)
Barriers to physical activity: measured via the Barriers in Physical Activity Questionnaire (total score)
Measured: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 7: Social support)
Social support: measured via the Social Provision Scale (total score)
Measured: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 8: Cardiorespiratory fitness)
Cardiorespiratory fitness: peak oxygen consumption (ml.kg-1.min-1)
Measured: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 9: Hand-grip strength)
Cardiorespiratory fitness: peak hand-grip strength (Newtons; both hands)
Measured: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 10: Lower extremity function)
Lower extremity function: measured via the Short Physical Performance Battery (total score)
Measured: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 11: Lower extremity function)
Lower extremity function: measured via the Timed Up and Go (total score)
Measured: Intervention (weeks 1 and 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start20 Apr 2021 (estimated)
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Why it stopped: Grant projects were revised in response to COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lakeshore Foundation
- Responsible party
- Principal investigator, Byron Lai, University of Alabama at Birmingham
- Investigators
- James H Rimmer, PhD, Study chair, University of Alabama at BirminghamHui-Ju Young, PhD, Study director, University of Alabama at BirminghamByron W Lai, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991273
- Sponsor's protocol ID
- 90DPGE0005-01-00
- Status last verified
- Apr 2021
- First submitted
- 13 Jun 2019
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make a de-identified copy of the final data set available after we have completed the final analysis. We will make the data set available to the scientific community through the Inter-University Consortium for Political and Social Research account (which enables free downloads via Internet).
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Implementation Efficacy of Movement-to-Music Delivered in a Community-Based Fitness Center and Blended Onsite and Home-based Group Teleexercise Class: A Mixed-Methods Pilot Study.
- ClinicalTrials.gov ID
- NCT03991273
- Acronym / sponsor ID
- 90DPGE0005-01-00
- Conditions
- Exercise, Disability Physical
- Keywords
- disability, disabilities, teleexercise, movement-to-music, physical activity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant projects were revised in response to COVID-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Lakeshore Foundation
- Study start
- 20 Apr 2021 (estimated)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 19 Jun 2019 (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.
To prepare for a large scale-up study, the goal of this pilot implementation trial is to examine the feasibility of Movement-to-Music (M2M©) delivery mechanisms through two channels: 1) a group-based M2M© program conducted onsite at a local YMCA; and 2) a blended program that provides Y-M2M© and a home-based M2M© (B-M2M©) via videoconferencing. A key element of this pilot is to examine issues associated with participant-provider interactions, and to better understand the robustness of the technology to deliver a group-based (teleexercise) version of M2M© in the home setting.
Detailed description
There will be 4 phases to this study. In phase 1, the investigators will explore potential barriers and supports that may affect the delivery of M2M© at one YMCA facility through one-on-one interviews with YMCA staff that have been trained to conduct M2M©.
Phase 2 will include a quantitative monitoring phase. During this phase the 2 delivery mechanisms of M2M© (Y-M2M© and B-M2M©) will be evaluated through assessments of quantitative feasibility metrics before, during, and after the intervention. The intervention will include a convenient sample of 54 participants.
To expand on the findings from the previous quantitative phase, phase 3 will include post-intervention focus group interviews conducted separately for each stakeholder group: all 54 participants, M2M© trainers, research assistants involved with technical support, and YMCA staff that were involved with the project.
During phase 4 (the integrative phase), the researchers will compile the quantitative and qualitative findings for the three primary feasibility metrics (process, resource, and management). These findings will then be comprehensively analyzed by a review panel that will provide suggestions for improvement within each metric. The panel will then discuss the summative findings and vote towards acceptable or not acceptable feasibility.
The 12-week Y-M2M© intervention will be pilot tested at one YMCA facility in Birmingham, AL.The B-M2M© group will be provided with the flexibility of attending the same onsite classes at the YMCA facility as participants in the Y-M2M© group and will also be able to participate in group M2M© teleexercise classes at home that are conducted through Internet video conferencing.
The investigators will use a permuted block randomization design to ensure close balance between the arms across waves and to increase the unpredictability in the upcoming assignment and prevent inadvertent bias. The project statistician will generate the randomization list that will be provided to the project coordinator in sealed envelopes to conceal the allocation. Assessors (health and function assessments done at Lakeshore Foundation) will be blinded to participant assignment and allocation of the arm assignment will not be done until baseline testing and measures are collected.
Primary quantitative outcomes will include those related to process, resources, and management. In summary, these metrics will include measures of adherence, issues that arise with implementation and the efficiency to which they are resolved, and intervention fidelity between the delivery sites. Secondary quantitative outcomes will include estimates of variability in scientific outcomes (physical activity; quality of life; social participation; fitness Measures (cardiorespiratory fitness, muscle strength, lower extremity function; social cognitive theory constructs [Self-efficacy, Outcome expectations, Barriers, Social support]).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-M2M© | Experimental | Other: Y-M2M©a group-based M2M© program conducted onsite at a local YMCA |
| B-M2M© | Experimental | Other: Y-M2M©, Other: B-M2M©a blended program that provides Y-M2M© and a home-based M2M© via videoconferencing |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary diagnosis of head injury, stroke, MS, spinal cord injury, spina bifida, Parkinson's disease or cerebral palsy conferred by a physician and fits one of the three functional mobility groups (Groups I-III);
- between the ages of 19 to 70 yrs.;
- physician clearance to participate;
- willing to participate in an exercise program 3 times per week;
- conversant in and reads English.
Key exclusion criteria (7 listed)
- participated in a similar intervention in the last 6 months;
- use of tobacco products in the last 6 months;
- cognitive impairment;
- active pressure ulcer;
- any contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines;
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 |
|---|---|---|
| Y-M2M©The Y-M2M© group will receive classes that will be delivered onsite at a YMCA facility. Movement-to-Music (M2M©) is an instructor-guided exercise program that is coupled with music to enhance strength, cardiorespiratory capacity, range of motion, and balance. | Other | B-M2M©, Y-M2M© |
| B-M2M©The B-M2M© group will receive the same onsite M2M© classes as the Y-M2M© group, but they will also be provided with the option of performing home-based M2M© that will be delivered via videoconferencing. | Other | B-M2M© |
Primary outcome
Phase 1: Foreseeable implementation barriers and supports as reported by YMCA trainers
Time frame: Pre-intervention (week 0)
Prior to conducting the intervention, the investigators will conduct interviews to qualitatively explore YMCA trainers' perceptions of organizational or system factors that can potentially facilitate the adoption of M2M© in YMCAs and tailor the M2M© delivery plan accordingly (using open-ended questions).
Phase 2: Quantitative feasibility metric (Process outcome #1:Enrollment Rate)
Time frame: Intervention (weeks 1-12)
Enrollment rate: the number of participants screened / total enrolled
Phase 2: Quantitative feasibility metric (Process outcome #2: Class Attendance)
Time frame: Intervention (weeks 1-12)
Attendance to the exercise sessions: total number of sessions attended divided by the total 36 prescribed sessions
Phase 2: Quantitative feasibility metric (Process outcome #3: Attrition Rate)
Time frame: Intervention (weeks 1-12)
Attrition rate: number of participants that withdraw from the intervention
Phase 2: Quantitative feasibility metric (Process outcome #4: Time to complete data collection)
Time frame: Intervention (weeks 1-12)
Time to complete data collection: time in minutes required to complete data collection (average of both pre- and post-data collection visit times)
Phase 2: Quantitative feasibility metric (Process outcome #1: Technical difficulties with technology)
Time frame: Intervention (weeks 1-12)
Technical difficulties with technology: Frequency of issues experienced by participants and trainers
Phase 2: Quantitative feasibility metric (Resource outcome #2: Resources required by the YMCA)
Time frame: Intervention (weeks 1-12)
Resources required by the YMCA: # of items purchased for a YMCA M2M class
Phase 2: Quantitative feasibility metric (Management outcome #1: M2M fidelity between conditions)
Time frame: Intervention (weeks 1-12)
M2M fidelity between conditions: the frequency of times a deviation from the protocol was observed for both the YMCA and Teleexercise classes.
Phase 2: Quantitative feasibility metric (Management outcome #2: Issues with data management)
Time frame: Intervention (weeks 1-12)
Issues with data management: frequency of issues encountered
Phase 3: Qualitative interview exploring stakeholders' perceptions of intervention implementation
Time frame: Post-Intervention (week 13)
Focus group interviews will be conducted separately for each stakeholder group: all 54 participants, M2M© trainers, research assistants involved with technical support, and YMCA staff that were involved with the project. The semi-structured interviews will explore participants' perceptions regarding the intervention implementation process, resources, and management (using open-ended questions)
11 secondary outcomes
Phase 2: Quantitative feasibility metric (Scientific outcome #1: Physical Activity)
Time frame: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome #2: Quality of life)
Time frame: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome #3: Social participation)
Time frame: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 4: Self-Efficacy)
Time frame: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 5: Outcome expectations)
Time frame: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 6: Barriers)
Time frame: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 7: Social support)
Time frame: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 8: Cardiorespiratory fitness)
Time frame: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 9: Hand-grip strength)
Time frame: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 10: Lower extremity function)
Time frame: Intervention (weeks 1 and 12)
Phase 2: Quantitative feasibility metric (Scientific outcome # 11: Lower extremity function)
Time frame: Intervention (weeks 1 and 12)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Individual participant dataSharing planned: Yes. We will make a de-identified copy of the final data set available after we have completed the final analysis. We will make the data set available to the scientific community through the Inter-University Consortium for Political and Social Research account (which enables free downloads via Internet).
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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.
James H Rimmer, PhD study chair
University of Alabama at Birmingham
Hui-Ju Young, PhD study director
University of Alabama at Birmingham
Byron W Lai, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Y-M2M© and B-M2M© in people with Exercise and Disability Physical, run by University of Alabama at Birmingham.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Phase 1: Foreseeable implementation barriers and supports as reported by YMCA trainers (time frame: Pre-intervention (week 0)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2021.