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出境医 / 临床实验 / Spinal Cord Injury Program in Exercise (SCIPE)

Spinal Cord Injury Program in Exercise (SCIPE)

Study Description
Brief Summary:
The purpose of this study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), with 327 adults with spinal cord injury. Enrolled participants will be randomized into one of three groups: a) M2M, b) SET, and c) attention control (AC).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Movement-to-Music Other: Standard Exercise Training Not Applicable

Detailed Description:
The purpose of the Spinal Cord Injury Program in Exercise (SCIPE) study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), with 327 adults with SCI. The primary aim is to examine change in physical activity level after the 8-week M2M and SET interventions. We hypothesize that participants in M2M and SET will have significant increase in physical activity compared to an Attention Control (AC) group after the 8-week intervention. The secondary aim is to examine effects of the M2M and SET interventions on health and quality of life outcomes. We hypothesize that participants in M2M and SET will have significant increases in sleep quality and quality of life and decreases in pain and fatigue compared to AC after the 8-week intervention. Exercise enjoyment in M2M and SET participants will also be explored. The tertiary aim is to evaluate the demographic (age, race, sex), clinical (level of injury, type of injury), and psychosocial (social support, outcome expectations, self-efficacy, self-regulation) variables of two participant groups: 1) compliant participants who completed ≥ 50% of the intervention, and 2) noncompliant participants who completed post-testing but < 50% of the intervention or who did not complete post-testing.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will be blinded to participants' group assignments throughout the study.
Primary Purpose: Other
Official Title: RERC on Technologies to Promote Exercise and Health Among People With Disabilities (A Scale Up Study Evaluating a Movement-to-Music Teleexercise Platform for Reaching a National Cohort of People With Spinal Cord Injury)
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : September 30, 2022
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Movement to Music (M2M)
All M2M sessions are delivered using videos uploaded to a secure study website (the SCIPE website). Participants in M2M will have access to the website and attend three 60-minute M2M sessions per week for a total of 8 weeks. Each session provides rhythmic-based exercises that are choreographed to music to target range of motion, muscular strength, cardiorespiratory fitness, and balance. In addition, participants in M2M will receive and read weekly educational articles on health and fitness through the SCIPE website.
Other: Movement-to-Music
The M2M program has been developed for onsite instruction and will be repurposed into an eHealth version. The program is based on the positive effects of exercise and music on both physiological and psychosocial outcomes in people with disabilities. Investigators aim to advance our current M2M program by enabling more robust personalization features, allowing people with SCI to individualize their M2M program. Movement and tempo-based adaptations will also be available. A typical M2M session will consist of tailored movement routines starting with a warmup using range of motion exercises, followed by muscle strengthening, cardiorespiratory, and/or balance routines, and ending with a cool down emphasizing breathing and mindfulness.
Other Name: M2M

Active Comparator: Standardised Exercise Training (SET)
All M2M sessions are delivered using videos uploaded to the SCIPE website. Participants in SET will have access to the website and attend three 60-minute SET sessions per week for a total of 8 weeks. Each session provides traditional exercises that target range of motion, muscular strength, cardiorespiratory fitness, and balance. In addition, participants in M2M will receive and read weekly educational articles on health and fitness through the SCIPE website.
Other: Standard Exercise Training
The SET program is based on the NCHPAD 14-Weeks to a Healthier You program launched in 2008. Exercise videos including range of motion, muscle strengthening, cardio and balance routines performed both seated and standing have been developed and will be restructured for use in this study. The SET program will be delivered through the same platform as M2M.
Other Name: SET

No Intervention: Attention Control (AC)
Participants in AC will not have access to any exercise videos. They will have access to the weekly educational articles on health and fitness, same as the ones received by the M2M and SET groups, through the SCIPE website.
Outcome Measures
Primary Outcome Measures :
  1. Changes from baseline physical activity level at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Physical activity is assessed using the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI). The LTPAQ-SCI is a 3-item, self-report questionnaire that measures the number of days and minutes people with SCI spend in mild, moderate, and heavy intensity leisure time physical activity in the last 7 days.


Secondary Outcome Measures :
  1. Changes from baseline pain intensity week 8 [ Time Frame: Baseline and post 8 week intervention ]
    The intensity of pain is assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Adult Short Form 3a (v1.0). The instrument is a 3-item measure with the response scores ranging from 1 (Had no pain) to 5 (Very severe). Higher scores indicate higher pain intensity. The total raw score will be translated into a T-score for each participant for analysis.

  2. Changes from baseline pain interference at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    The influence of pain on performing daily activities is assessed with the NIH PROMIS Pain Interference Adult Short Form 8a (v1.0), which contains 8 items with 5 response options ranging from 1 (Not at all) to 5 (Very much). The form has raw scores range from 8 to 40, with higher scores indicating more pain interference. The total raw score will be translated into a T-score for each participant for analysis.

  3. Changes from baseline sleep quality at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Sleep quality is assessed using the NIH PROMIS Sleep Disturbance Adult Short Form 8a, which contains 8 items on a 5-point Likert scale, ranging from 1 (Very much) to 5 (Not at all). The form has raw scores range from 8 to 40, with higher scores indicating worst sleep quality. The total raw score will be translated into a T-score for each participant for analysis.

  4. Changes from baseline fatigue level at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Fatigue is measured using the NIH PROMIS Fatigue Adult Short Form. The instrument is a 8 items on a 5-point Likert scale, ranging from 1 (Not at all/Never) to 5 (Very much/Always). Higher scores indicate higher fatigue. The total raw score is translated into a T-score for each participant for analysis.

  5. Changes from baseline health-related quality of life at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Health-related quality of life is assessed using the NIH PROMIS 10 Global Health Items. The Global-10 Health form is a 10-item measure with the response scores ranging from 1 (Poor/Not at all/Always/Very severe) to 5 (Excellent/Completely/Never/None). One question item, "how would you rate your pain on average?", is on a 11-point Likert scale that ranges from 0 (No pain) to 10 (Worst pain imaginable). Higher scores indicate better health-related quality of life. Two summary scores, a Global Physical Health score and a Global Mental Health score, can be derived from this instrument.

  6. Changes from baseline ability to participate in social roles and activities at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Social participation is measured using the NIH PROMIS Ability to Participate in Social Roles and Activities Short Form 8a. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is translated into a T-score for each participant for analysis.

  7. Exercise enjoyment at week 8 [ Time Frame: Post 8 week intervention ]
    Exercise enjoyment is assessed using Physical Activity Enjoyment Scale. The Physical Activity Enjoyment Scale contains 8 items, with higher score indicates greater exercise enjoyment.


Other Outcome Measures:
  1. Baseline self-efficacy [ Time Frame: Baseline ]
    Self-efficacy is measured using the Exercise Self-Efficacy Scale, which contains 8 items with response options of each item ranging from 0% (Not at all confident) to 100% (Highly confident). Higher scores indicate higher levels of exercise self-efficacy.

  2. Baseline self-regulation [ Time Frame: Baseline ]
    Self-regulation is measured using the Exercise Goal-Setting Scale, which contains 10 items on a 5-point Likert scale that ranges from 1 (Does not describe) to 5 (Describes completely). A higher mean score indicate better goal-setting and self-monitoring for exercise.

  3. Baseline social support [ Time Frame: Baseline ]
    Social support is measured using the Social Provisions Scale, which contains 24 items with response options ranging from 1 (Strongly disagree) to 4 (Strongly agree). A higher score indicates a greater degree of perceived support.

  4. Baseline outcome expectations [ Time Frame: Baseline ]
    Outcome expectations is measured using the Multidimensional Outcome Expectations for Exercise Scale, which contains 15 items on a 5-point Likert scale, ranging from 1 (Strongly disagree) to 5 (Strongly agree). Three domains of outcome expectations, including the physical outcome expectations, the social outcome expectations, and the self-evaluative outcome expectations, will be derived from this scale. Each domain is scored individually and a higher score indicates higher level of outcome expectations for exercise.

  5. Participant adherence throughout the 8-week intervention period [ Time Frame: During the 8-week intervention ]
    Participant dherence will be assessed using the percentage of the number of exercise session each participant attend over the 8-week intervention period.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with a SCI resulting in incomplete or complete (C5 and below) paraplegia or tetraplegia;
  2. Demonstrate readiness to physical activity by completing the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+);
  3. Obtain medical clearance if required by PAR-Q+;
  4. Converse in and read English.

Exclusion Criteria:

  1. No broadband internet access;
  2. Significant visual impairment that prevents seeing a computer screen to follow a home exercise program;
  3. Currently pregnant.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sangeetha Padalabalanarayanan, MS 2059750550 sangee@uab.edu
Contact: Hui-Ju (Zoe) Young, PhD 2054035521 hjyoung@uab.edu

Locations
Layout table for location information
United States, Alabama
RecTech Center Recruiting
Birmingham, Alabama, United States, 35209
Contact: Sangeetha Padalabalanarayanan, MS         
Sponsors and Collaborators
University of Alabama at Birmingham
Tracking Information
First Submitted Date  ICMJE March 27, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date February 17, 2021
Actual Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2020)
Changes from baseline physical activity level at week 8 [ Time Frame: Baseline and post 8 week intervention ]
Physical activity is assessed using the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI). The LTPAQ-SCI is a 3-item, self-report questionnaire that measures the number of days and minutes people with SCI spend in mild, moderate, and heavy intensity leisure time physical activity in the last 7 days.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2019)
  • Changes from baseline physical activity level at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    The physical activity level is assessed using Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury
  • Changes from baseline physical activity level at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    The physical activity level is assessed using Godin Leisure-Time Exercise Questionnaire
  • Changes from baseline pain level at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Pain level is assessed using, Pain intensity (NIH PROMIS Pain Intensity short form)
  • Changes from baseline pain level at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Pain level is assessed using pain interference (NIH PROMIS Pain Interference short form)
  • Changes from baseline fatigue level at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Fatigue level is assessed using NIH PROMIS Fatigue short form
  • Changes from quality of life at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Quality of life is assessed using NIH PROMIS Global Health Items
  • Changes from quality of life at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Quality of life is assessed using and NIH PROMIS Ability to Participate in Social Roles and Activities
  • Changes from baseline sleep quality level at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Sleep quality is assessed using NIH PROMIS Sleep Disturbance short form
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2020)
  • Changes from baseline pain intensity week 8 [ Time Frame: Baseline and post 8 week intervention ]
    The intensity of pain is assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Adult Short Form 3a (v1.0). The instrument is a 3-item measure with the response scores ranging from 1 (Had no pain) to 5 (Very severe). Higher scores indicate higher pain intensity. The total raw score will be translated into a T-score for each participant for analysis.
  • Changes from baseline pain interference at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    The influence of pain on performing daily activities is assessed with the NIH PROMIS Pain Interference Adult Short Form 8a (v1.0), which contains 8 items with 5 response options ranging from 1 (Not at all) to 5 (Very much). The form has raw scores range from 8 to 40, with higher scores indicating more pain interference. The total raw score will be translated into a T-score for each participant for analysis.
  • Changes from baseline sleep quality at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Sleep quality is assessed using the NIH PROMIS Sleep Disturbance Adult Short Form 8a, which contains 8 items on a 5-point Likert scale, ranging from 1 (Very much) to 5 (Not at all). The form has raw scores range from 8 to 40, with higher scores indicating worst sleep quality. The total raw score will be translated into a T-score for each participant for analysis.
  • Changes from baseline fatigue level at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Fatigue is measured using the NIH PROMIS Fatigue Adult Short Form. The instrument is a 8 items on a 5-point Likert scale, ranging from 1 (Not at all/Never) to 5 (Very much/Always). Higher scores indicate higher fatigue. The total raw score is translated into a T-score for each participant for analysis.
  • Changes from baseline health-related quality of life at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Health-related quality of life is assessed using the NIH PROMIS 10 Global Health Items. The Global-10 Health form is a 10-item measure with the response scores ranging from 1 (Poor/Not at all/Always/Very severe) to 5 (Excellent/Completely/Never/None). One question item, "how would you rate your pain on average?", is on a 11-point Likert scale that ranges from 0 (No pain) to 10 (Worst pain imaginable). Higher scores indicate better health-related quality of life. Two summary scores, a Global Physical Health score and a Global Mental Health score, can be derived from this instrument.
  • Changes from baseline ability to participate in social roles and activities at week 8 [ Time Frame: Baseline and post 8 week intervention ]
    Social participation is measured using the NIH PROMIS Ability to Participate in Social Roles and Activities Short Form 8a. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is translated into a T-score for each participant for analysis.
  • Exercise enjoyment at week 8 [ Time Frame: Post 8 week intervention ]
    Exercise enjoyment is assessed using Physical Activity Enjoyment Scale. The Physical Activity Enjoyment Scale contains 8 items, with higher score indicates greater exercise enjoyment.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2019)
  • Changes in Adherence throughout the 8 weeks period [ Time Frame: Post 8 week intervention ]
    Adherence will be assessed using the percentage of the number of exercise session each participant attend over the 8-week intervention period.
  • Changes in Exercise Enjoyment at week 8 [ Time Frame: Post 8 week intervention ]
    Exercise enjoyment will be assessed using Physical Activity Enjoyment Scale. The Physical Activity Enjoyment Scale contains 8 items on a 5-likert scale ranging from strongly agree (5) to strongly disagree (1). Higher score indicates higher exercise enjoyment.
Current Other Pre-specified Outcome Measures
 (submitted: September 23, 2020)
  • Baseline self-efficacy [ Time Frame: Baseline ]
    Self-efficacy is measured using the Exercise Self-Efficacy Scale, which contains 8 items with response options of each item ranging from 0% (Not at all confident) to 100% (Highly confident). Higher scores indicate higher levels of exercise self-efficacy.
  • Baseline self-regulation [ Time Frame: Baseline ]
    Self-regulation is measured using the Exercise Goal-Setting Scale, which contains 10 items on a 5-point Likert scale that ranges from 1 (Does not describe) to 5 (Describes completely). A higher mean score indicate better goal-setting and self-monitoring for exercise.
  • Baseline social support [ Time Frame: Baseline ]
    Social support is measured using the Social Provisions Scale, which contains 24 items with response options ranging from 1 (Strongly disagree) to 4 (Strongly agree). A higher score indicates a greater degree of perceived support.
  • Baseline outcome expectations [ Time Frame: Baseline ]
    Outcome expectations is measured using the Multidimensional Outcome Expectations for Exercise Scale, which contains 15 items on a 5-point Likert scale, ranging from 1 (Strongly disagree) to 5 (Strongly agree). Three domains of outcome expectations, including the physical outcome expectations, the social outcome expectations, and the self-evaluative outcome expectations, will be derived from this scale. Each domain is scored individually and a higher score indicates higher level of outcome expectations for exercise.
  • Participant adherence throughout the 8-week intervention period [ Time Frame: During the 8-week intervention ]
    Participant dherence will be assessed using the percentage of the number of exercise session each participant attend over the 8-week intervention period.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Cord Injury Program in Exercise
Official Title  ICMJE RERC on Technologies to Promote Exercise and Health Among People With Disabilities (A Scale Up Study Evaluating a Movement-to-Music Teleexercise Platform for Reaching a National Cohort of People With Spinal Cord Injury)
Brief Summary The purpose of this study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), with 327 adults with spinal cord injury. Enrolled participants will be randomized into one of three groups: a) M2M, b) SET, and c) attention control (AC).
Detailed Description The purpose of the Spinal Cord Injury Program in Exercise (SCIPE) study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), with 327 adults with SCI. The primary aim is to examine change in physical activity level after the 8-week M2M and SET interventions. We hypothesize that participants in M2M and SET will have significant increase in physical activity compared to an Attention Control (AC) group after the 8-week intervention. The secondary aim is to examine effects of the M2M and SET interventions on health and quality of life outcomes. We hypothesize that participants in M2M and SET will have significant increases in sleep quality and quality of life and decreases in pain and fatigue compared to AC after the 8-week intervention. Exercise enjoyment in M2M and SET participants will also be explored. The tertiary aim is to evaluate the demographic (age, race, sex), clinical (level of injury, type of injury), and psychosocial (social support, outcome expectations, self-efficacy, self-regulation) variables of two participant groups: 1) compliant participants who completed ≥ 50% of the intervention, and 2) noncompliant participants who completed post-testing but < 50% of the intervention or who did not complete post-testing.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
The outcome assessor will be blinded to participants' group assignments throughout the study.
Primary Purpose: Other
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • Other: Movement-to-Music
    The M2M program has been developed for onsite instruction and will be repurposed into an eHealth version. The program is based on the positive effects of exercise and music on both physiological and psychosocial outcomes in people with disabilities. Investigators aim to advance our current M2M program by enabling more robust personalization features, allowing people with SCI to individualize their M2M program. Movement and tempo-based adaptations will also be available. A typical M2M session will consist of tailored movement routines starting with a warmup using range of motion exercises, followed by muscle strengthening, cardiorespiratory, and/or balance routines, and ending with a cool down emphasizing breathing and mindfulness.
    Other Name: M2M
  • Other: Standard Exercise Training
    The SET program is based on the NCHPAD 14-Weeks to a Healthier You program launched in 2008. Exercise videos including range of motion, muscle strengthening, cardio and balance routines performed both seated and standing have been developed and will be restructured for use in this study. The SET program will be delivered through the same platform as M2M.
    Other Name: SET
Study Arms  ICMJE
  • Active Comparator: Movement to Music (M2M)
    All M2M sessions are delivered using videos uploaded to a secure study website (the SCIPE website). Participants in M2M will have access to the website and attend three 60-minute M2M sessions per week for a total of 8 weeks. Each session provides rhythmic-based exercises that are choreographed to music to target range of motion, muscular strength, cardiorespiratory fitness, and balance. In addition, participants in M2M will receive and read weekly educational articles on health and fitness through the SCIPE website.
    Intervention: Other: Movement-to-Music
  • Active Comparator: Standardised Exercise Training (SET)
    All M2M sessions are delivered using videos uploaded to the SCIPE website. Participants in SET will have access to the website and attend three 60-minute SET sessions per week for a total of 8 weeks. Each session provides traditional exercises that target range of motion, muscular strength, cardiorespiratory fitness, and balance. In addition, participants in M2M will receive and read weekly educational articles on health and fitness through the SCIPE website.
    Intervention: Other: Standard Exercise Training
  • No Intervention: Attention Control (AC)
    Participants in AC will not have access to any exercise videos. They will have access to the weekly educational articles on health and fitness, same as the ones received by the M2M and SET groups, through the SCIPE website.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2019)
327
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date August 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosed with a SCI resulting in incomplete or complete (C5 and below) paraplegia or tetraplegia;
  2. Demonstrate readiness to physical activity by completing the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+);
  3. Obtain medical clearance if required by PAR-Q+;
  4. Converse in and read English.

Exclusion Criteria:

  1. No broadband internet access;
  2. Significant visual impairment that prevents seeing a computer screen to follow a home exercise program;
  3. Currently pregnant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sangeetha Padalabalanarayanan, MS 2059750550 sangee@uab.edu
Contact: Hui-Ju (Zoe) Young, PhD 2054035521 hjyoung@uab.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925077
Other Study ID Numbers  ICMJE IRB-300003133
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hui-Ju Young, PhD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP