Lower Back InjuryNCT05834959
Implementation of a Fitness Education and Training Program to Support Safe Patient Handling and Safe Lifting
A study testing An Educational and Training Program in people with Lower Back Injury, run by University of Manitoba at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Back Injury
- What is being tested?
- An Educational and Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- An acute injury, a medical condition, or other personal reason inhibiting participation in all 4 weeks of exercise training sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Back Injury
- Being tested
- An Educational and Training Program
- Keywords
- Safe Patient Handling, Safe Lifting, Injury Prevention., Program Outcome Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An Educational and Training ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| SOGH employees, taking part in the same education and training program. | Experimental | Participants will be recruited from the Seven Oak General Hospital staff population and will complete a two-part education and practical program. Receives: Other: An Educational and Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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:
- Get down to and back up from the floor without using support
- Walk continuously for 1 hour
- Balance on 1 foot for 30 seconds
- Bend over to clean the bath tub
- Move the fridge to clean behind it
- Lift a 24 pack of water bottles off the floor
- Place carry-on luggage in overhead bin on airplane
- Lift a heavy suitcase in and out of the trunk of a car.
- Carry 2 heavy bags of groceries 100 ft or 30 m
- Shovel snow from a 1 car driveway.
Measured: 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
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)
Measured: 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
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).
Measured: 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
Measured as change in the number of new low back injuries or flare-ups of existing back conditions sustained in the past year.
Measured: 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
Measured as the number of new low back injuries or flare-ups of existing back conditions sustained at work in the past year.
Measured: 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
Measured as the duration of time away from work due to low back pain/injury.
Measured: At the beginning of the program (baseline), and 1 year after completion of the 4-week training program
Secondary outcomes (1)
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
A "Program Exit Questionnaire" will be administered to collect participant experiences and views on the benefits and challenges associated with the program.
Measured: Collected at week 4 (at the end of the 4-week training program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start14 Mar 2023
- Primary completion11 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back InjuryStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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. SPSS software will be used to analyze mean differences between self-report questionnaire scores regarding low back pain/dysfunction at baseline and post-program using paired t-tests (p\<0.05). Paired t-tests will be used to determine if there is a statistical difference in back injury rates at Seven Oaks Hospital one year post-program, compared to previous years. The results of the post-program survey will be summarized using descriptive statistics. Information from baseline movement confidence questionnaires will also be summarized using descriptive statistics and compared pre and post programming. \*Note: Before t-test analyses is performed the distribution of scores will be checked to determine if they are normal. If not, non-parametric tests equivalent to paired t-tests will be used.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- The Wellness Institute Powered by Seven Oaks General Hospital, Workers Compensation Board of Manitoba, Seven Oaks General Hospital
- Responsible party
- Principal investigator, Shelley Sargent, University of Manitoba
- Investigators
- Shelley Sargent, BMRPT MSc, Principal investigator, The Wellness Institute at Seven Oaks General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834959
- Sponsor's protocol ID
- HS25745 (H2022:355)
- Status last verified
- Nov 2023
- First submitted
- 13 Mar 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05834959
- Acronym / sponsor ID
- HS25745 (H2022:355)
- Conditions
- Lower Back Injury
- Keywords
- Safe Patient Handling, Safe Lifting, Injury Prevention., Program Outcome Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- The Wellness Institute Powered by Seven Oaks General Hospital, Workers Compensation Board of Manitoba, Seven Oaks General Hospital
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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. SPSS software will be used to analyze mean differences between self-report questionnaire scores regarding low back pain/dysfunction at baseline and post-program using paired t-tests (p<0.05). Paired t-tests will be used to determine if there is a statistical difference in back injury rates at Seven Oaks Hospital one year post-program, compared to previous years. The results of the post-program survey will be summarized using descriptive statistics. Information from baseline movement confidence questionnaires will also be summarized using descriptive statistics and compared pre and post programming. *Note: Before t-test analyses is performed the distribution of scores will be checked to determine if they are normal. If not, non-parametric tests equivalent to paired t-tests will be used.
| Arm | Type | Receives |
|---|---|---|
| SOGH employees, taking part in the same education and training program. | Experimental | Other: An Educational and Training ProgramParticipants will be recruited from the Seven Oak General Hospital staff population and will complete a two-part education and practical program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- An acute injury, a medical condition, or other personal reason inhibiting participation in all 4 weeks of exercise training sessions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An Educational and Training ProgramEducation 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 | Other | SOGH employees, taking part in the same education and training program. |
Primary outcome
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.
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)
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).
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.
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.
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley Sargent, BMRPT MSc principal investigator
The Wellness Institute at Seven Oaks General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An Educational and Training Program in people with Lower Back Injury, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.