Real-time Videoconference-based Exercise in Eldercare Workers

Study Overview
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Brief Summary
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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.

Official Title
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Effects of a Real-time Videoconference-based Exercise Program in Eldercare Workers: a Randomized Controlled Trial

Conditions
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Pain, Mental Disorders

Intervention / Treatment
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* Behavioral: Real-time videoconference-based Exercise program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise program<br>Participants in the experimental group will take part in a 12-week exercise program. | Behavioral: Real-time videoconference-based Exercise program<br>* 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.<br>|
| No Intervention: Control<br>Participants in the control group will not receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline and at 12-week follow-up | 
| 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. | At baseline and at 48-week follow-up | 
| 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. | At baseline and at 12-week follow-up | 
| 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. | At baseline and at 48-week follow-up | 
| 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. | At baseline and at 12-week follow-up | 
| 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. | At baseline and at 48-week follow-up | 
| 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. | At baseline and at 12-week follow-up | 
| 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. | At baseline and at 48-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic medication consumption frequency | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eldercare, Caregiver, Exercise, Tele-health, Musculoskeletal disorders, Mental disorders, Absenteeism, Work ability, Work performance