Implementation of a Fitness Education and Training Program to Support Safe Patient Handling and Safe Lifting

November 14, 2023 updated by: Shelley Sargent, University of Manitoba

Implementation of a Fitness Education and Training Program to Support Safe Patient Handling and Safe Lifting in a Community Based Hospital (The Fit for Work Project)

This project involves the delivery of education and training sessions to Seven Oaks General Hospital (SOGH) staff, with the goal of workplace injury prevention. Education will include review of provincial safe patient handling and back injury prevention guidelines and review of core fitness competencies required to comply with injury prevention standards. Training sessions will include exercises to improve core, gluteal and quadricep strength, hip/knee mobility and hamstring flexibility. Training will also be an opportunity to provide feedback on functional movement performance. Outcomes will include questionnaires on: low back pain/dysfunction; movement confidence; work injury rates and participant satisfaction with program. The project will advise stakeholders of the benefits and challenges associated with implementation of a fitness program to support safe patient handling techniques, as outlined in the provincial guidelines for healthcare workers.

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

The Fit for Work Project is an educational and training program outcome evaluation. It is a two-part education and practical program designed to evaluate the effects of training on movement confidence, low back dysfunction and changes in rates of lower back injury. In the first part, participants will attend the education session developed by physiotherapists who specialize in return to work programs. In the second part participants will participate in a 4-week practical program, where they will stretch, lengthen and strengthen key muscles used in squatting, weight shifting and the hip hinge movement. Feedback and movement coaching are an important element in performing and mastering these movements correctly and this workplace wellness training program will provide staff the support needed.

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.
55

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2P 2W7.
        • The Wellness Institute

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female, age 18 years or older
  • Staff of Seven Oaks General Hospital during the time of the program
  • Able to communicate in English and provide written informed consent

Exclusion Criteria:

  • An acute injury, a medical condition, or other personal reason inhibiting participation in all 4 weeks of exercise training sessions

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: N/A
  • Interventional Model: Single Group 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: SOGH employees, taking part in the same education and training program.
Participants will be recruited from the Seven Oak General Hospital staff population and will complete a two-part education and practical program.
Other: An Educational and Training Program
Education and practical training program designed to evaluate the effects of training on movement confidence, low back dysfunction and changes in rates of lower back injury

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
Change from baseline in staff confidence in performing the core fitness competencies required to abide by safe patient handling, safe lifting and back injury prevention guidelines
Time Frame: At the beginning of the program (baseline), at week 4 (the end of the 4-week training program), and one year after completion of the training program

A Movement Confidence Questionnaire will be used, asking participants to rate their confidence as either 1-Very Low, 2-Low, 3-Moderate, 4-High, 5-Very High in completing 10 different movements without difficulty:

  1. Get down to and back up from the floor without using support
  2. Walk continuously for 1 hour
  3. Balance on 1 foot for 30 seconds
  4. Bend over to clean the bath tub
  5. Move the fridge to clean behind it
  6. Lift a 24 pack of water bottles off the floor
  7. Place carry-on luggage in overhead bin on airplane
  8. Lift a heavy suitcase in and out of the trunk of a car.
  9. Carry 2 heavy bags of groceries 100 ft or 30 m
  10. Shovel snow from a 1 car driveway.
At the beginning of the program (baseline), at week 4 (the end of the 4-week training program), and one year after completion of the training program
Change from baseline in severity of low back pain and/or dysfunction
Time Frame: At the beginning of the program (baseline), at week 4 (the end of the 4-week training program), and one year after completion of the training program
Measured as change from baseline in the Quebec Back Pain Disability Scale (Designed to evaluate functional limitations related to pain, to monitor the progress of individual patients and to compare the evolution of lower back pain (LBP) subjects incorporated in rehabilitation programs)
At the beginning of the program (baseline), at week 4 (the end of the 4-week training program), and one year after completion of the training program
Change from baseline in severity of low back pain and/or dysfunction
Time Frame: At the beginning of the program (baseline), at week 4 (the end of the 4-week training program), and one year after completion of the training program
Measured as change from baseline in the Oswestry Disability Index, also known as the Oswestry Low Back Pain Disability Questionnaire. (A self-reported measurement tool that measures both pain and functional status. It is used for evaluating disability caused by lower backache).
At the beginning of the program (baseline), at week 4 (the end of the 4-week training program), and one year after completion of the training program
Change from baseline in incidence of back injuries
Time Frame: At the beginning of the program (baseline), and 1 year after completion of the 4-week training program
Measured as change in the number of new low back injuries or flare-ups of existing back conditions sustained in the past year.
At the beginning of the program (baseline), and 1 year after completion of the 4-week training program
Change from baseline in frequency of back injuries
Time Frame: At the beginning of the program (baseline), and 1 year after completion of the 4-week training program
Measured as the number of new low back injuries or flare-ups of existing back conditions sustained at work in the past year.
At the beginning of the program (baseline), and 1 year after completion of the 4-week training program
Change from baseline in time loss cost of back injuries
Time Frame: At the beginning of the program (baseline), and 1 year after completion of the 4-week training program
Measured as the duration of time away from work due to low back pain/injury.
At the beginning of the program (baseline), and 1 year after completion of the 4-week training program

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Benefits and challenges associated with implementation of a fitness program to support safe patient handling and safe lifting techniques, as outlined in the provincial and regional guidelines for healthcare workers
Time Frame: Collected at week 4 (at the end of the 4-week training program)
A "Program Exit Questionnaire" will be administered to collect participant experiences and views on the benefits and challenges associated with the program.
Collected at week 4 (at the end of the 4-week training program)

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.
University of Manitoba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Workers Compensation Board of Manitoba
Seven Oaks General Hospital
The Wellness Institute Powered by Seven Oaks General Hospital

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: Shelley Sargent, BMRPT MSc, The Wellness Institute at Seven Oaks General Hospital

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.
March 14, 2023

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.
September 11, 2023

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.
October 30, 2023

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 13, 2023

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.
April 17, 2023

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 28, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
November 17, 2023

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.
November 14, 2023

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.
November 1, 2023

More Information

Terms related to this study

Keywords

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.
  • HS25745 (H2022:355)

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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