- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05050526
Real-time Videoconference-based Exercise in Eldercare Workers (ReViEEW)
Effects of a Real-time Videoconference-based Exercise Program in Eldercare Workers: a Randomized Controlled Trial
Formal caregiving of elderly dependent people is a both physically and psychologically demanding job, and both musculoskeletal and mental disorders with a negative impact in general health and quality of life are habitual among eldercare workers. Previous research has shown that physical exercise programs can reduce and/or prevent those disorders, consequently improving well-being at work.
Online exercise interventions might be a cost-effective tool, as they can reach a large number of people at a relatively low cost. Moreover, they are compatible with situations in which interpersonal physical distancing is required, such as the current COVID-19 pandemic. However, real-time videoconference-based exercise interventions have not yet been studied in working populations.
Thus, the aim of this study is to assess the effects of a real-time videoconference-based exercise intervention in eldercare workers. The primary outcome will be low back pain. Pain in neck, shoulders and wrists/hands will also be recorded, as well as additional measures of physical fitness, psychoaffective state, health and work-related variables. All outcomes will be measured at baseline and at 12-week and 48-week follow-ups.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bizkaia
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Portugalete, Bizkaia, Spain, 48920
- Residencia Aspaldiko
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Gipuzkoa
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Hondarribia, Gipuzkoa, Spain, 20280
- Caser Residencial Betharram
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Professional eldercare workers with ≥3 months of experience in the profession
- Employment contract at least until the anticipated date of study end
Exclusion Criteria:
- Pregnancy
- Contraindication to exercise according to the American College of Sports Medicine Guidelines
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Exercise program
Participants in the experimental group will take part in a 12-week exercise program.
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12-week exercise program consisting of two weekly 45 minute group-based sessions, remotely supervised by a professional via real-time videoconference.
Each session will consist of a warm-up (5-10 min), general strengthening (30 min) and cool-down (5-10 min).
Warm-up will include general joint mobility and exercises focused on increasing heart rate.
General strengthening will include 4 series of 6 exercises (2 for lower limb, 2 for upper limb and 2 for the trunk) performed with minimal equipment, combining body-weight and elastic-band exercises.
Three difficulty levels will be set for each of the exercises, and progression will be made at weeks 5 and 9. Participants will be asked to work in a given rate of perceived exertion (between 3 and 5 in Borg's CR10 scale) and not to reach failure in any of the exercises.
Cool-down will include stretching and breathing/relaxing exercises.
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No Intervention: Control
Participants in the control group will not receive any intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change from baseline average pain intensity at 12 weeks
Time Frame: At baseline and at 12-week follow-up
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Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain).
This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
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At baseline and at 12-week follow-up
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Change from baseline average pain intensity at 48 weeks
Time Frame: At baseline and at 48-week follow-up
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Average pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain).
This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
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At baseline and at 48-week follow-up
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Change from baseline highest pain intensity at 12 weeks
Time Frame: At baseline and at 12-week follow-up
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Highest pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain).
This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
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At baseline and at 12-week follow-up
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Change from baseline highest pain intensity at 48 weeks
Time Frame: At baseline and at 48-week follow-up
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Highest pain intensity during the last 7 days in a Numerical Rating Scale for pain ranging from 0 (complete absence of pain) to 10 (worst imaginable pain).
This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
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At baseline and at 48-week follow-up
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Change from baseline pain frequency at 12 weeks
Time Frame: At baseline and at 12-week follow-up
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Number of days in pain during the last 7 days (0-7).
This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
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At baseline and at 12-week follow-up
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Change from baseline pain frequency at 48 weeks
Time Frame: At baseline and at 48-week follow-up
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Number of days in pain during the last 7 days (0-7).
This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
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At baseline and at 48-week follow-up
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Change from baseline pain interference at 12 weeks
Time Frame: At baseline and at 12-week follow-up
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Number of days in which pain negatively interferes with work during the last 7 days of work (0-7).
This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
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At baseline and at 12-week follow-up
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Change from baseline pain interference at 48 weeks
Time Frame: At baseline and at 48-week follow-up
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Number of days in which pain negatively interferes with work during the last 7 days of work (0-7).
This information will be collected for pain in the low back, neck, shoulders and wrists/hands.
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At baseline and at 48-week follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Analgesic medication consumption frequency
Time Frame: At baseline and at 12-week and 48-week follow-ups
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Number of days in which analgesic medication is taken during the last 7 days (0-7).
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At baseline and at 12-week and 48-week follow-ups
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5-repetition sit-to-stand test
Time Frame: At baseline and at 12-week and 48-week follow-ups
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It measures lower limb strength based on the time taken by the participant to get up from and sit down on a chair five times as quickly as possible.
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At baseline and at 12-week and 48-week follow-ups
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Kneeling push-up test
Time Frame: At baseline and at 12-week and 48-week follow-ups
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It measures upper limb strength based on the maximum number of "knee push-ups" the participant can perform until failure.
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At baseline and at 12-week and 48-week follow-ups
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Shirado-Ito trunk flexor endurance test
Time Frame: At baseline and at 12-week and 48-week follow-ups
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It measures trunk flexor endurance based on the maximum time the participant is able to maintain a defined body position, which mainly activates trunk flexor muscles.
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At baseline and at 12-week and 48-week follow-ups
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Subjective Happiness scale
Time Frame: At baseline and at 12-week and 48-week follow-ups
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It is comprised of 4 items, each of them answered with a score between 1 and 7. A single composite score is obtained by averaging the responses to the 4 items, and a higher score corresponds to a greater happiness.
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At baseline and at 12-week and 48-week follow-ups
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Goldberg Anxiety and Depression scale
Time Frame: At baseline and at 12-week and 48-week follow-ups
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The scale includes 9 items for anxiety symptoms and 9 items for depression symptoms.
Each item is answered with a "Yes" or a "No".
A higher number of positive answers corresponds to a higher risk of suffering a clinically relevant anxiety or depression disorder, respectively.
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At baseline and at 12-week and 48-week follow-ups
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Maslach Burnout Inventory
Time Frame: At baseline and at 12-week and 48-week follow-ups
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The Inventory is comprised of 22 items corresponding to three domains: personal accomplishment, emotional exhaustion and depersonalization.
Each item is answered in a 0-6 Likert scale depending on the frequency with which the participant experiences the feelings described.
One total score per domain is obtained.
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At baseline and at 12-week and 48-week follow-ups
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Single-Item Sleep Quality Scale
Time Frame: At baseline and at 12-week and 48-week follow-ups
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It evaluates overall sleep quality in the last 7 days with a numerical scale that ranges between 0 (terrible) and 10 (excellent).
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At baseline and at 12-week and 48-week follow-ups
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Hypnotic/anxiolytic medication consumption frequency
Time Frame: At baseline and at 12-week and 48-week follow-ups
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Number of days in which hypnotic/anxiolytic medication is taken during the last 7 days (0-7).
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At baseline and at 12-week and 48-week follow-ups
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EuroQol-5D 0-100 health state scale
Time Frame: At baseline and at 12-week and 48-week follow-ups
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It measures self-perceived current health state in a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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At baseline and at 12-week and 48-week follow-ups
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Work Ability
Time Frame: At baseline and at 12-week and 48-week follow-ups
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Work ability will be assessed by the following item extracted from the Workability Index: "assuming that your work ability at its best has a value of 10 points, how many points would you rate your current work ability?".
Participants are asked to give a score ranging from 0 (completely unable to work) to 10 (lifetime best work ability).
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At baseline and at 12-week and 48-week follow-ups
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Work Performance
Time Frame: At baseline and at 12-week and 48-week follow-ups
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Work performance will be assessed by the following item extracted from the World Health Organization Health and Work Performance Questionnaire: "On a scale from 0 to 10 where 0 is the worst job performance anyone could have at your job and 10 is the performance of a top worker, how would you rate your overall work performance on the days you worked during the last 12 weeks?"
Participants are asked to give a score between 0 and 10.
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At baseline and at 12-week and 48-week follow-ups
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Borg's CR-10 scale for perceived physical exertion at work
Time Frame: At baseline and at 12-week and 48-week follow-ups
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It measures perceived physical exertion while doing physical work in a scale ranging from 0 (nothing at all) to 10 (extremely strong).
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At baseline and at 12-week and 48-week follow-ups
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Absenteeism
Time Frame: At baseline and at 12-week and 48-week follow-ups
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Days of absence from work during the last year will be collected from the official registry of the company and by self-reported questionnaire.
Presence of absenteeism (yes/no), days of absence (n) and reason will be collected.
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At baseline and at 12-week and 48-week follow-ups
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ander Espin, PhD Student, University of the Basque Country (UPV/EHU)
Publications and helpful links
General Publications
- Espin A, Irazusta J, Segovia Celaya I, Mosquera Lajas A, Gonzalez-Templado V, Rodriguez-Larrad A. Effects of a videoconference-based therapeutic exercise intervention on the musculoskeletal pain of eldercare workers: protocol for the ReViEEW randomized controlled trial. BMC Musculoskelet Disord. 2023 Jun 6;24(1):463. doi: 10.1186/s12891-023-06584-7.
- Espin A, Irazusta J, Aiestaran M, Latorre Erezuma U, Garcia-Garcia J, Arrinda I, Acedo K, Rodriguez-Larrad A. Videoconference-Supervised Group Exercise Reduces Low Back Pain in Eldercare Workers: Results from the ReViEEW Randomised Controlled Trial. J Occup Rehabil. 2024 Apr 17. doi: 10.1007/s10926-024-10182-2. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eldercare2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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