CClinicalTrials.gg
CompletedNCT03489720Updated Apr 14, 2020Results posted

Evaluation of a Daily Brief Exercise Intervention on Resident Physician Personal Resiliency and Burnout

An interventional study of Prescribed Exercise Program and Usual Exercise Program in Burnout, Professional and Burnout Syndrome, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-14.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This study seeks to evaluate the prevalence and characterize predictors of physician burnout in the anesthesia residency at Vanderbilt University Medical Center. The study also seeks to evaluate the effect of an exercise intervention on burnout and personal resiliency (i.e., less individual stress given the same workload).

Read the detailed description

A cross-sectional evaluation of burnout, perceived stress, average sleep propensity, and social support and coping mechanisms will be assessed from four years of Vanderbilt University Medical Center (VUMC) Anesthesia residents. Burnout will be assessed using the Maslach Burnout Inventory (MBI-HSS).

Participating interns, Anesthesia Residency Class 1 (CA-1), and Anesthesia Residency Class 2 (CA-2) classes will be randomized to 8 weeks of an exercise intervention (15 min of activity at 70% of max heart rate or higher, 5 days a week) to meet the activity recommendations of the Office of Disease Prevention and Health Promotion or 8 weeks of continuing their baseline activity level prior to the study.

02

Conditions studied

  • Burnout, Professional
  • Burnout Syndrome
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Vanderbilt University Medical Center Anesthesiology residents (Class 1(CA-1), Class 2 (CA-2)

Exclusion criteria

Exclusion Criteria:

  • Failure to sign informed consent
  • Will not be in town and available for the full duration of the study (e.g., 2 or more weeks of vacation or absence)
  • Physical inability to perform the exercise intervention (including health indications)
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Arm A: Exercise intervention then usual exercise program

    8 weeks of exercise intervention followed by 8 weeks of usual exercise program

    Behavioral: Prescribed Exercise Program · Behavioral: Usual Exercise Program

  • Active comparator
    Arm B: Usual Exercise Program then exercise intervention

    8 weeks of usual exercise program followed by 8 weeks of exercise intervention

    Behavioral: Prescribed Exercise Program · Behavioral: Usual Exercise Program

Interventions

  • BehavioralPrescribed Exercise Program

    Brief cardiovascular exercise training (\>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks. The exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2. Examples of possible 15-minute exercise regimens to be used include: * Walking quickly or running up and down stairs * Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc * Walking up an incline on a treadmill * Jogging or running on a treadmill or elliptical * Stationary cycling or rowing

  • BehavioralUsual Exercise Program

    Usual exercise activity for 8 weeks

05

What researchers measure

Primary outcomes

  1. The Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI)From Baseline to End of Each Exercise Phase.

    The change in the Emotional Exhaustion (EE) burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\<EE\<19 points. Low levels will be considered for EE≤18 points.

    Time frame: Baseline to 8 weeks

  2. The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.

    The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points.

    Time frame: Baseline to 8 weeks

  3. The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.

    The change in the Personal Accomplishment (PA) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points.

    Time frame: Baseline to 8 weeks

  4. Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by MBI From Baseline to End of Each Exercise Phase Stratified by Training Level (Post Graduate Year 1 (PGY1), Post Graduate Year 2 (PGY2), and Post Graduate Year 3 (PGY3))

    The change in the Emotional Exhaustion burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase stratified by training level. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS includes 9 items to evaluate emotional exhaustion (EE) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\<EE\<19 points. Low levels will be considered for EE≤18 points.

    Time frame: Baseline to 8 weeks

  5. The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.

    The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level. MBI-HSS is a survey to measure burnout in professionals in human services. DP MBI-HSS includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP ≥ 10. Moderate burnout will be considered in the case of 6\<DP\<9 points. Low levels will be considered for DP≤5 points.

    Time frame: Baseline to 8 weeks

  6. The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.

    The change in the PA burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level. MBI-HSS is a survey to measure burnout in professionals in human services. PA MBI-HSS includes 8 items to evaluate personal accomplishment (PA), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points.

    Time frame: Baseline to 8 weeks

  7. The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Emotional Exhaustion (EE) MBI-HSS Scores Broken Down by Level of Residency Training Completed.

    The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Emotional Exhaustion MBI-HSS scores broken down by level of residency training completed. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\<EE\<19 points. Low levels will be considered for EE≤18 points.

    Time frame: Baseline

  8. The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Depersonalization MBI-HSS Scores Broken Down by Level of Residency Training Completed.

    The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Depersonalization MBI-HSS scores broken down by level of residency training completed. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points.

    Time frame: Baseline

  9. The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Personal Accomplishment (PA) MBI-HSS Scores Broken Down by Level of Residency Training Completed.

    The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Personal Accomplishment MBI-HSS scores broken down by level of residency training completed. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 DP points. Low levels will be considered for DP ≤31 points.

    Time frame: Baseline

06

Results

Posted Apr 14, 2020

Participant flow

Participant flow — Overall Study
MilestoneArm A: Exercise Intervention Then Usual Exercise ProgramArm B: Usual Exercise Program Then Exercise Intervention
Started2422
Completed2222
Not completed20
Withdrew: Withdrawal by subject20

Outcome measures

PrimaryThe Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI)From Baseline to End of Each Exercise Phase.

The change in the Emotional Exhaustion (EE) burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\<EE\<19 points. Low levels will be considered for EE≤18 points.

Time frame:
Baseline to 8 weeks
Reported as:
Mean · units on a scale
The Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI)From Baseline to End of Each Exercise Phase.
units on a scaleExercise InterventionUsual Exercise Program
Baseline20.95348837 ± 9.75644716820.93023256 ± 10.40694674
Change after 8 weeks of exercise phase-0.976190476 ± 7.416159335-0.095238095 ± 6.472491599
PrimaryThe Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.

The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points.

Time frame:
Baseline to 8 weeks
Reported as:
Mean · units on a scale
The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.
units on a scaleExercise InterventionUsual Exercise Program
Baseline8.465116279 ± 4.7626965018.181818182 ± 5.077413402
Change after 8 weeks of usual exercise program0.139534884 ± 3.412731034-0.727272727 ± 3.743916842
PrimaryThe Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.

The change in the Personal Accomplishment (PA) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points.

Time frame:
Baseline to 8 weeks
Reported as:
Mean · units on a scale
The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.
units on a scaleExercise InterventionUsual Exercise Program
Baseline34.13636364 ± 6.72928659634.95348837 ± 7.107854436
Change after 8 weeks of usual exercise program0.209302326 ± 6.2356812720.738095238 ± 5.355915461
PrimaryChange in the Emotional Exhaustion (EE) Burnout Score(as Measured by MBI From Baseline to End of Each Exercise Phase Stratified by Training Level (Post Graduate Year 1 (PGY1), Post Graduate Year 2 (PGY2), and Post Graduate Year 3 (PGY3))

The change in the Emotional Exhaustion burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase stratified by training level. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS includes 9 items to evaluate emotional exhaustion (EE) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\<EE\<19 points. Low levels will be considered for EE≤18 points.

Time frame:
Baseline to 8 weeks
Reported as:
Mean · units on a scale
Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by MBI From Baseline to End of Each Exercise Phase Stratified by Training Level (Post Graduate Year 1 (PGY1), Post Graduate Year 2 (PGY2), and Post Graduate Year 3 (PGY3))
units on a scaleExercise InterventionUsual Exercise Program
Post graduate year 1: Baseline21.2 ± 10.3799256820.125 ± 11.43022309
Post graduate year 1: Change after 8 weeks-2.266666667 ± 5.66274374-2.0625 ± 6.287222492
Post graduate year 2: Baseline20.84615385 ± 9.94858577820.84615385 ± 10.07344822
Post graduate year 2: Change after 8 weeks1.846153846 ± 8.4345139540.833333333 ± 5.89067059
Post graduate year 3: Baseline20.8 ± 9.63772350121.92857143 ± 10.17889435
Post graduate year 3: Change after 8 weeks-2.214285714 ± 7.8561937492.071428571 ± 6.521730371
PrimaryThe Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.

The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level. MBI-HSS is a survey to measure burnout in professionals in human services. DP MBI-HSS includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP ≥ 10. Moderate burnout will be considered in the case of 6\<DP\<9 points. Low levels will be considered for DP≤5 points.

Time frame:
Baseline to 8 weeks
Reported as:
Mean · units on a scale
The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.
units on a scaleExercise InterventionUsual Exercise Program
Post graduate year 1: Baseline6.866666667 ± 4.5960645696.3125 ± 5.055937104
Post graduate year 1: Change after 8 weeks-1.266666667 ± 2.865226659-1.8125 ± 4.354595274
Post graduate year 2: Baseline9.461538462 ± 4.5021362459.615384615 ± 4.233565509
Post graduate year 2: Change after 8 weeks0.846153846 ± 3.262058497-0.076923077 ± 2.985005261
Post graduate year 3: Baseline9.2 ± 5.0313304128.933333333 ± 5.470265946
Post graduate year 3: Change after 8 weeks0.933333333 ± 3.7884536360.4 ± 3.581699517
PrimaryThe Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.

The change in the PA burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level. MBI-HSS is a survey to measure burnout in professionals in human services. PA MBI-HSS includes 8 items to evaluate personal accomplishment (PA), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points.

Time frame:
Baseline to 8 weeks
Reported as:
Mean · units on a scale
The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.
units on a scaleExercise InterventionUsual Exercise Program
Post graduate year 1: Baseline33 ± 7.45654075334.2 ± 7.775419144
Post graduate year 1: Change after 8 weeks-0.2 ± 6.6354028841.428571429 ± 5.243520334
Post graduate year 2: Baseline36.15384615 ± 6.269584736.38461538 ± 6.776656766
Post graduate year 2: Change after 8 weeks1 ± 4.7958315231 ± 5.016638981
Post graduate year 3: Baseline33.6 ± 6.34485168134.46666667 ± 6.998639324
Post graduate year 3: Change after 8 weeks0.466666667 ± 7.199867724-0.133333333 ± 5.962581735
PrimaryThe Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Emotional Exhaustion (EE) MBI-HSS Scores Broken Down by Level of Residency Training Completed.

The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Emotional Exhaustion MBI-HSS scores broken down by level of residency training completed. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\<EE\<19 points. Low levels will be considered for EE≤18 points.

Time frame:
Baseline
Reported as:
Mean · units on a scale
The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Emotional Exhaustion (EE) MBI-HSS Scores Broken Down by Level of Residency Training Completed.
units on a scalePost Graduate Year 1Post Graduate Year 2Post Graduate Year 3
The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Emotional Exhaustion (EE) MBI-HSS Scores Broken Down by Level of Residency Training Completed.20.29412 ± 8.85836316.80000 ± 10.25531227.64286 ± 12.481415
PrimaryThe Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Depersonalization MBI-HSS Scores Broken Down by Level of Residency Training Completed.

The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Depersonalization MBI-HSS scores broken down by level of residency training completed. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points.

Time frame:
Baseline
Reported as:
Mean · units on a scale
The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Depersonalization MBI-HSS Scores Broken Down by Level of Residency Training Completed.
units on a scalePost Graduate Year 1Post Graduate Year 2Post Graduate Year 3
The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Depersonalization MBI-HSS Scores Broken Down by Level of Residency Training Completed.7.647059 ± 5.0860256.266667 ± 4.8176269.357143 ± 6.570413
PrimaryThe Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Personal Accomplishment (PA) MBI-HSS Scores Broken Down by Level of Residency Training Completed.

The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Personal Accomplishment MBI-HSS scores broken down by level of residency training completed. MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 DP points. Low levels will be considered for DP ≤31 points.

Time frame:
Baseline
Reported as:
Mean · units on a scale
The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Personal Accomplishment (PA) MBI-HSS Scores Broken Down by Level of Residency Training Completed.
units on a scalePost Graduate Year 1Post Graduate Year 2Post Graduate Year 3
The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Personal Accomplishment (PA) MBI-HSS Scores Broken Down by Level of Residency Training Completed.34.41176 ± 6.82878834.60000 ± 8.58403833.35714 ± 9.352969

Adverse events

Collected over 16 weeks of study participation. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Exercise Intervention0/46 (0%)0/46 (0%)0/46 (0%)
Usual Exercise Program0/44 (0%)0/44 (0%)0/44 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Exercise Intervention Then Usual Exercise ProgramUsual Exercise Program Then Exercise InterventionTotal
<=18 years000
Between 18 and 65 years242246
>=65 years000
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Exercise Intervention Then Usual Exercise ProgramUsual Exercise Program Then Exercise InterventionTotal
Female111223
Male101020
Not reported303
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Exercise Intervention Then Usual Exercise ProgramUsual Exercise Program Then Exercise InterventionTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Exercise Intervention Then Usual Exercise ProgramUsual Exercise Program Then Exercise InterventionTotal
United States242246
07

Study locations

1 site
  • Vanderbilt Unversity Medical Center
    Nashville, Tennessee 37232, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 18, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03489720
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Uma Shastri (Assistant Professor of Anesthesiology, Vanderbilt University Medical Center) — Principal investigator
First posted
Apr 5, 2018
Start date
Jun 1, 2018
Primary completion
Dec 26, 2018
Completion
Dec 26, 2018
Results posted
Apr 14, 2020
Last update
Apr 14, 2020

Study contacts

Uma Shastri, MD, PhD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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