Real-time Videoconference-based Exercise in Eldercare Workers (ReViEEW)

May 23, 2024 updated by: Ander Espin

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bizkaia
      • Portugalete, Bizkaia, Spain, 48920
        • Residencia Aspaldiko
    • Gipuzkoa
      • Hondarribia, Gipuzkoa, Spain, 20280
        • Caser Residencial Betharram

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Exercise program
Participants in the experimental group will take part in a 12-week exercise program.
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.
No Intervention: Control
Participants in the control group will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline average pain intensity at 12 weeks
Time Frame: At baseline and at 12-week follow-up
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.
At baseline and at 12-week follow-up
Change from baseline average pain intensity at 48 weeks
Time Frame: At baseline and at 48-week follow-up
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.
At baseline and at 48-week follow-up
Change from baseline highest pain intensity at 12 weeks
Time Frame: At baseline and at 12-week follow-up
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.
At baseline and at 12-week follow-up
Change from baseline highest pain intensity at 48 weeks
Time Frame: At baseline and at 48-week follow-up
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.
At baseline and at 48-week follow-up
Change from baseline pain frequency at 12 weeks
Time Frame: At baseline and at 12-week follow-up
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.
At baseline and at 12-week follow-up
Change from baseline pain frequency at 48 weeks
Time Frame: At baseline and at 48-week follow-up
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.
At baseline and at 48-week follow-up
Change from baseline pain interference at 12 weeks
Time Frame: At baseline and at 12-week follow-up
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.
At baseline and at 12-week follow-up
Change from baseline pain interference at 48 weeks
Time Frame: At baseline and at 48-week follow-up
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.
At baseline and at 48-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic medication consumption frequency
Time Frame: At baseline and at 12-week and 48-week follow-ups
Number of days in which analgesic medication is taken during the last 7 days (0-7).
At baseline and at 12-week and 48-week follow-ups
5-repetition sit-to-stand test
Time Frame: At baseline and at 12-week and 48-week follow-ups
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.
At baseline and at 12-week and 48-week follow-ups
Kneeling push-up test
Time Frame: At baseline and at 12-week and 48-week follow-ups
It measures upper limb strength based on the maximum number of "knee push-ups" the participant can perform until failure.
At baseline and at 12-week and 48-week follow-ups
Shirado-Ito trunk flexor endurance test
Time Frame: At baseline and at 12-week and 48-week follow-ups
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.
At baseline and at 12-week and 48-week follow-ups
Subjective Happiness scale
Time Frame: At baseline and at 12-week and 48-week follow-ups
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.
At baseline and at 12-week and 48-week follow-ups
Goldberg Anxiety and Depression scale
Time Frame: At baseline and at 12-week and 48-week follow-ups
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.
At baseline and at 12-week and 48-week follow-ups
Maslach Burnout Inventory
Time Frame: At baseline and at 12-week and 48-week follow-ups
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.
At baseline and at 12-week and 48-week follow-ups
Single-Item Sleep Quality Scale
Time Frame: At baseline and at 12-week and 48-week follow-ups
It evaluates overall sleep quality in the last 7 days with a numerical scale that ranges between 0 (terrible) and 10 (excellent).
At baseline and at 12-week and 48-week follow-ups
Hypnotic/anxiolytic medication consumption frequency
Time Frame: At baseline and at 12-week and 48-week follow-ups
Number of days in which hypnotic/anxiolytic medication is taken during the last 7 days (0-7).
At baseline and at 12-week and 48-week follow-ups
EuroQol-5D 0-100 health state scale
Time Frame: At baseline and at 12-week and 48-week follow-ups
It measures self-perceived current health state in a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
At baseline and at 12-week and 48-week follow-ups
Work Ability
Time Frame: At baseline and at 12-week and 48-week follow-ups
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).
At baseline and at 12-week and 48-week follow-ups
Work Performance
Time Frame: At baseline and at 12-week and 48-week follow-ups
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.
At baseline and at 12-week and 48-week follow-ups
Borg's CR-10 scale for perceived physical exertion at work
Time Frame: At baseline and at 12-week and 48-week follow-ups
It measures perceived physical exertion while doing physical work in a scale ranging from 0 (nothing at all) to 10 (extremely strong).
At baseline and at 12-week and 48-week follow-ups
Absenteeism
Time Frame: At baseline and at 12-week and 48-week follow-ups
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.
At baseline and at 12-week and 48-week follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Ander Espin, PhD Student, University of the Basque Country (UPV/EHU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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