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

April 1, 2020 updated by: Uma Shastri, Vanderbilt University Medical Center
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Unversity Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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
Behavioral: Usual Exercise Program
Usual exercise activity for 8 weeks
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

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
Behavioral: Usual Exercise Program
Usual exercise activity for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline to 8 weeks

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.
Baseline to 8 weeks
The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.
Time Frame: Baseline to 8 weeks

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.
Baseline to 8 weeks
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.
Time Frame: Baseline to 8 weeks

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.
Baseline to 8 weeks
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))
Time Frame: Baseline to 8 weeks

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.
Baseline to 8 weeks
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.
Time Frame: Baseline to 8 weeks

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.
Baseline to 8 weeks
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.
Time Frame: Baseline to 8 weeks

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.
Baseline to 8 weeks
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.
Time Frame: Baseline

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.
Baseline
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.
Time Frame: Baseline

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.
Baseline
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.
Time Frame: Baseline

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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Uma Shastri, MD, PhD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 180313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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