Musculoskeletal PainNCT03501147
The Effect of a Resistance Training Program in Healthcare Workers on Pain, Workability and Physical Function.
A study testing Resistance training in people with Musculoskeletal Pain and Physical Function, run by University of Valencia at 1 site in Spain.
Trial summary
The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Physical Function, Work Ability
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 17 Apr 2018to 19 Jun 2018
- 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
- Healthcare Workers at the Hospital
- Informed consent
Who cannot join
- Unable to perform exercises
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Brief Daily Resistance Training Program in Healthcare Workers on Pain, Workability and Physical Function.
The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work.
Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to perform a brief intervention. This study is intended to investigate the difference between the effect of workplace-based physical exercise (using elastic bands and body weight exercises) and a group control on musculoskeletal pain, physical exertion during work, physical function, need for recovery, self-rated use of analgesics, and work ability among healthcare workers.
- Conditions
- Musculoskeletal Pain, Physical Function, Work Ability
- Being tested
- Resistance training
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
15 minutes of resistance training during work every day
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 15 minutes of resistance training at the work place every day Receives: Other: Resistance training |
| Control | No intervention | Usual work |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain overall status: Standard 7-point patient global impression
Standard 7-point patient global impression of pain collected at the endpoint
Measured: 2 days after the end of intervention (POST)
Secondary outcomes (20)
Workability Index
Questionnaire work ability
Measured: Baseline
Workability Index
Questionnaire work ability
Measured: 2 days after the end of intervention (POST)
Physical function
Physical tests (push-ups, Biering-Sorensen test, Sit to Stand)
Measured: Baseline
Physical function
Physical tests (push-ups, Biering-Sorensen test, Sit to Stand)
Measured: 2 days after the end of intervention (POST)
Perceived physical exertion
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Measured: Baseline
Perceived physical exertion
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Measured: 3 weeks of resistance training
Perceived physical exertion
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Measured: 6 weeks of resistance training
Perceived physical exertion
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Measured: 2 days after the end of intervention (POST)
"Need for recovery scale" after work
Five point scale (1 = never, 5 = always)
Measured: Baseline
"Need for recovery scale" after work
Five point scale (1 = never, 5 = always)
Measured: 3 weeks of resistance training
"Need for recovery scale" after work
Five point scale (1 = never, 5 = always)
Measured: 6 weeks of resistance training
"Need for recovery scale" after work
Five point scale (1 = never, 5 = always)
Measured: 2 days after the end of intervention (POST)
Self-rated use of analgesics
The number of days the participants used analgesics during the last week
Measured: Baseline
Self-rated use of analgesics
The number of days the participants used analgesics during the last week
Measured: 3 weeks of resistance training
Self-rated use of analgesics
The number of days the participants used analgesics during the last week
Measured: 6 weeks of resistance training
Self-rated use of analgesics
The number of days the participants used analgesics during the last week
Measured: 2 days after the end of intervention (POST)
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10, 0 = not pain, 10 = worst possible pain)
Measured: Baseline
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10, 0 = not pain, 10 = worst possible pain)
Measured: 3 weeks of resistance training
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10, 0 = not pain, 10 = worst possible pain)
Measured: 6 weeks of resistance training
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10, 0 = not pain, 10 = worst possible pain)
Measured: 2 days after the end of intervention (POST)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start17 Apr 2018
- Primary completion19 Jun 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Casaña Granell, University of Valencia
- Investigators
- Jose C Granell, PhD, Study chair, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501147
- Sponsor's protocol ID
- 0000260894
- Status last verified
- Oct 2019
- First submitted
- 13 Mar 2018
- Last updated
- 8 Oct 2019
- Results posted
- 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 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Brief Daily Resistance Training Program in Healthcare Workers on Pain, Workability and Physical Function.
- ClinicalTrials.gov ID
- NCT03501147
- Acronym / sponsor ID
- 0000260894
- Conditions
- Musculoskeletal Pain, Physical Function, Work Ability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 18 Apr 2018 (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.
The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work.
Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to perform a brief intervention. This study is intended to investigate the difference between the effect of workplace-based physical exercise (using elastic bands and body weight exercises) and a group control on musculoskeletal pain, physical exertion during work, physical function, need for recovery, self-rated use of analgesics, and work ability among healthcare workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Resistance training15 minutes of resistance training at the work place every day |
| Control | No intervention | –Usual work |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthcare Workers at the Hospital
- Informed consent
Key exclusion criteria (1 listed)
- Unable to perform exercises
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 |
|---|---|---|
| Resistance training15 minutes of resistance training during work every day | Other | Intervention |
Primary outcome
Pain overall status: Standard 7-point patient global impression
Time frame: 2 days after the end of intervention (POST)
Standard 7-point patient global impression of pain collected at the endpoint
20 secondary outcomes
Workability Index
Time frame: Baseline
Workability Index
Time frame: 2 days after the end of intervention (POST)
Physical function
Time frame: Baseline
Physical function
Time frame: 2 days after the end of intervention (POST)
Perceived physical exertion
Time frame: Baseline
Perceived physical exertion
Time frame: 3 weeks of resistance training
Perceived physical exertion
Time frame: 6 weeks of resistance training
Perceived physical exertion
Time frame: 2 days after the end of intervention (POST)
"Need for recovery scale" after work
Time frame: Baseline
"Need for recovery scale" after work
Time frame: 3 weeks of resistance training
"Need for recovery scale" after work
Time frame: 6 weeks of resistance training
"Need for recovery scale" after work
Time frame: 2 days after the end of intervention (POST)
Self-rated use of analgesics
Time frame: Baseline
Self-rated use of analgesics
Time frame: 3 weeks of resistance training
Self-rated use of analgesics
Time frame: 6 weeks of resistance training
Self-rated use of analgesics
Time frame: 2 days after the end of intervention (POST)
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Time frame: Baseline
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Time frame: 3 weeks of resistance training
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Time frame: 6 weeks of resistance training
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Time frame: 2 days after the end of intervention (POST)
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 8 Oct 2019.
- 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.
Jose C Granell, PhD study chair
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Musculoskeletal Pain and Physical Function, run by University of Valencia at 1 site in Spain.
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 2 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 8 Oct 2019. 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 Spain. 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?
Pain overall status: Standard 7-point patient global impression (time frame: 2 days after the end of intervention (POST)). 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 8 Oct 2019.