The Effect of a Resistance Training Program in Healthcare Workers on Pain, Workability and Physical Function.
Primary Purpose
Musculoskeletal Pain, Physical Function, Work Ability
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Resistance training
Sponsored by
About this trial
This is an interventional prevention trial for Musculoskeletal Pain
Eligibility Criteria
Inclusion Criteria:
- Healthcare Workers at the Hospital
- Informed consent
Exclusion Criteria:
- Unable to perform exercises
Sites / Locations
- Clinic Universitary Hospital of Valencia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
15 minutes of resistance training at the work place every day
Usual work
Outcomes
Primary Outcome Measures
Pain overall status: Standard 7-point patient global impression
Standard 7-point patient global impression of pain collected at the endpoint
Secondary Outcome Measures
Workability Index
Questionnaire work ability
Workability Index
Questionnaire work ability
Physical function
Physical tests (push-ups, Biering-Sorensen test, Sit to Stand)
Physical function
Physical tests (push-ups, Biering-Sorensen test, Sit to Stand)
Perceived physical exertion
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Perceived physical exertion
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Perceived physical exertion
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Perceived physical exertion
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
"Need for recovery scale" after work
Five point scale (1 = never, 5 = always)
"Need for recovery scale" after work
Five point scale (1 = never, 5 = always)
"Need for recovery scale" after work
Five point scale (1 = never, 5 = always)
"Need for recovery scale" after work
Five point scale (1 = never, 5 = always)
Self-rated use of analgesics
The number of days the participants used analgesics during the last week
Self-rated use of analgesics
The number of days the participants used analgesics during the last week
Self-rated use of analgesics
The number of days the participants used analgesics during the last week
Self-rated use of analgesics
The number of days the participants used analgesics during the last week
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)
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03501147
Brief Title
The Effect of a Resistance Training Program in Healthcare Workers on Pain, Workability and Physical Function.
Official Title
The Effect of a Brief Daily Resistance Training Program in Healthcare Workers on Pain, Workability and Physical Function.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
June 19, 2018 (Actual)
Study Completion Date
June 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Physical Function, Work Ability
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
15 minutes of resistance training at the work place every day
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual work
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
15 minutes of resistance training during work every day
Primary Outcome Measure Information:
Title
Pain overall status: Standard 7-point patient global impression
Description
Standard 7-point patient global impression of pain collected at the endpoint
Time Frame
2 days after the end of intervention (POST)
Secondary Outcome Measure Information:
Title
Workability Index
Description
Questionnaire work ability
Time Frame
Baseline
Title
Workability Index
Description
Questionnaire work ability
Time Frame
2 days after the end of intervention (POST)
Title
Physical function
Description
Physical tests (push-ups, Biering-Sorensen test, Sit to Stand)
Time Frame
Baseline
Title
Physical function
Description
Physical tests (push-ups, Biering-Sorensen test, Sit to Stand)
Time Frame
2 days after the end of intervention (POST)
Title
Perceived physical exertion
Description
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Time Frame
Baseline
Title
Perceived physical exertion
Description
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Time Frame
3 weeks of resistance training
Title
Perceived physical exertion
Description
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Time Frame
6 weeks of resistance training
Title
Perceived physical exertion
Description
Based on Borg's rate of perceived exertion (RPE) (Borg CR10 scale)
Time Frame
2 days after the end of intervention (POST)
Title
"Need for recovery scale" after work
Description
Five point scale (1 = never, 5 = always)
Time Frame
Baseline
Title
"Need for recovery scale" after work
Description
Five point scale (1 = never, 5 = always)
Time Frame
3 weeks of resistance training
Title
"Need for recovery scale" after work
Description
Five point scale (1 = never, 5 = always)
Time Frame
6 weeks of resistance training
Title
"Need for recovery scale" after work
Description
Five point scale (1 = never, 5 = always)
Time Frame
2 days after the end of intervention (POST)
Title
Self-rated use of analgesics
Description
The number of days the participants used analgesics during the last week
Time Frame
Baseline
Title
Self-rated use of analgesics
Description
The number of days the participants used analgesics during the last week
Time Frame
3 weeks of resistance training
Title
Self-rated use of analgesics
Description
The number of days the participants used analgesics during the last week
Time Frame
6 weeks of resistance training
Title
Self-rated use of analgesics
Description
The number of days the participants used analgesics during the last week
Time Frame
2 days after the end of intervention (POST)
Title
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Description
Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10, 0 = not pain, 10 = worst possible pain)
Time Frame
Baseline
Title
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Description
Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10, 0 = not pain, 10 = worst possible pain)
Time Frame
3 weeks of resistance training
Title
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Description
Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10, 0 = not pain, 10 = worst possible pain)
Time Frame
6 weeks of resistance training
Title
Pain: Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Description
Average pain intensity (Visual Analogue Scale (VAS) Scale 0-10, 0 = not pain, 10 = worst possible pain)
Time Frame
2 days after the end of intervention (POST)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthcare Workers at the Hospital
Informed consent
Exclusion Criteria:
Unable to perform exercises
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose C Granell, PhD
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
Facility Information:
Facility Name
Clinic Universitary Hospital of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of a Resistance Training Program in Healthcare Workers on Pain, Workability and Physical Function.
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