Real-time Videoconference-based Exercise in Eldercare Workers (ReViEEW)
Primary Purpose
Pain, Mental Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Real-time videoconference-based Exercise program
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring Eldercare, Caregiver, Exercise, Tele-health, Musculoskeletal disorders, Mental disorders, Absenteeism, Work ability, Work performance
Eligibility Criteria
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
Sites / Locations
- Residencia AspaldikoRecruiting
- Caser Residencial Betharram
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise program
Control
Arm Description
Participants in the experimental group will take part in a 12-week exercise program.
Participants in the control group will not receive any intervention.
Outcomes
Primary Outcome Measures
Change from baseline average pain intensity at 12 weeks
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.
Change from baseline average pain intensity at 48 weeks
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.
Change from baseline highest pain intensity at 12 weeks
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.
Change from baseline highest pain intensity at 48 weeks
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.
Change from baseline pain frequency at 12 weeks
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.
Change from baseline pain frequency at 48 weeks
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.
Change from baseline pain interference at 12 weeks
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.
Change from baseline pain interference at 48 weeks
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.
Secondary Outcome Measures
Analgesic medication consumption frequency
Number of days in which analgesic medication is taken during the last 7 days (0-7).
5-repetition sit-to-stand test
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.
Kneeling push-up test
It measures upper limb strength based on the maximum number of "knee push-ups" the participant can perform until failure.
Shirado-Ito trunk flexor endurance test
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.
Subjective Happiness scale
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.
Goldberg Anxiety and Depression scale
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.
Maslach Burnout Inventory
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.
Single-Item Sleep Quality Scale
It evaluates overall sleep quality in the last 7 days with a numerical scale that ranges between 0 (terrible) and 10 (excellent).
Hypnotic/anxiolytic medication consumption frequency
Number of days in which hypnotic/anxiolytic medication is taken during the last 7 days (0-7).
EuroQol-5D 0-100 health state scale
It measures self-perceived current health state in a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Work Ability
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).
Work Performance
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.
Borg's CR-10 scale for perceived physical exertion at work
It measures perceived physical exertion while doing physical work in a scale ranging from 0 (nothing at all) to 10 (extremely strong).
Absenteeism
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.
Full Information
NCT ID
NCT05050526
First Posted
September 9, 2021
Last Updated
September 20, 2022
Sponsor
Ander Espin
Collaborators
Caser Residencial Betharram, Fundación Aspaldiko, Grupo Servicios Sociales Integrados, Igurco Residencias Sociosanitarias, Grupo Colisée
1. Study Identification
Unique Protocol Identification Number
NCT05050526
Brief Title
Real-time Videoconference-based Exercise in Eldercare Workers
Acronym
ReViEEW
Official Title
Effects of a Real-time Videoconference-based Exercise Program in Eldercare Workers: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ander Espin
Collaborators
Caser Residencial Betharram, Fundación Aspaldiko, Grupo Servicios Sociales Integrados, Igurco Residencias Sociosanitarias, Grupo Colisée
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Mental Disorders
Keywords
Eldercare, Caregiver, Exercise, Tele-health, Musculoskeletal disorders, Mental disorders, Absenteeism, Work ability, Work performance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigators in charge of doing the statistical analysis and assessing the outcome measures (e.g., physical performance tests) will be blinded to group allocation. Due to the characteristics of the study, blinding of the participants (i.e., eldercare workers) and the care provider (i.e., professional conducting the exercise sessions) to the group allocation is not possible.
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise program
Arm Type
Experimental
Arm Description
Participants in the experimental group will take part in a 12-week exercise program.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in the control group will not receive any intervention.
Intervention Type
Behavioral
Intervention Name(s)
Real-time videoconference-based Exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline average pain intensity at 12 weeks
Description
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.
Time Frame
At baseline and at 12-week follow-up
Title
Change from baseline average pain intensity at 48 weeks
Description
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.
Time Frame
At baseline and at 48-week follow-up
Title
Change from baseline highest pain intensity at 12 weeks
Description
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.
Time Frame
At baseline and at 12-week follow-up
Title
Change from baseline highest pain intensity at 48 weeks
Description
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.
Time Frame
At baseline and at 48-week follow-up
Title
Change from baseline pain frequency at 12 weeks
Description
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.
Time Frame
At baseline and at 12-week follow-up
Title
Change from baseline pain frequency at 48 weeks
Description
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.
Time Frame
At baseline and at 48-week follow-up
Title
Change from baseline pain interference at 12 weeks
Description
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.
Time Frame
At baseline and at 12-week follow-up
Title
Change from baseline pain interference at 48 weeks
Description
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.
Time Frame
At baseline and at 48-week follow-up
Secondary Outcome Measure Information:
Title
Analgesic medication consumption frequency
Description
Number of days in which analgesic medication is taken during the last 7 days (0-7).
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
5-repetition sit-to-stand test
Description
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.
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Kneeling push-up test
Description
It measures upper limb strength based on the maximum number of "knee push-ups" the participant can perform until failure.
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Shirado-Ito trunk flexor endurance test
Description
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.
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Subjective Happiness scale
Description
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.
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Goldberg Anxiety and Depression scale
Description
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.
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Maslach Burnout Inventory
Description
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.
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Single-Item Sleep Quality Scale
Description
It evaluates overall sleep quality in the last 7 days with a numerical scale that ranges between 0 (terrible) and 10 (excellent).
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Hypnotic/anxiolytic medication consumption frequency
Description
Number of days in which hypnotic/anxiolytic medication is taken during the last 7 days (0-7).
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
EuroQol-5D 0-100 health state scale
Description
It measures self-perceived current health state in a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Work Ability
Description
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).
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Work Performance
Description
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.
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Borg's CR-10 scale for perceived physical exertion at work
Description
It measures perceived physical exertion while doing physical work in a scale ranging from 0 (nothing at all) to 10 (extremely strong).
Time Frame
At baseline and at 12-week and 48-week follow-ups
Title
Absenteeism
Description
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.
Time Frame
At baseline and at 12-week and 48-week follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ander Espin, PhD Student
Phone
00-34-946012845
Email
ander.espin@ehu.eus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ander Espin, PhD Student
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Residencia Aspaldiko
City
Portugalete
State/Province
Bizkaia
ZIP/Postal Code
48920
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Álvaro Mosquera
Phone
00-34-944625000
Email
amosquera@aspaldiko.org
Facility Name
Caser Residencial Betharram
City
Hondarribia
State/Province
Gipuzkoa
ZIP/Postal Code
20280
Country
Spain
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Learn more about this trial
Real-time Videoconference-based Exercise in Eldercare Workers
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