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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05050526
Other study ID # Eldercare2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date April 30, 2024

Study information

Verified date May 2024
Source University of the Basque Country (UPV/EHU)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Real-time videoconference-based 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.

Locations

Country Name City State
Spain Caser Residencial Betharram Hondarribia Gipuzkoa
Spain Residencia Aspaldiko Portugalete Bizkaia

Sponsors (6)

Lead Sponsor Collaborator
Ander Espin Caser Residencial Betharram, Fundación Aspaldiko, Grupo Colisée, Grupo Servicios Sociales Integrados, Igurco Residencias Sociosanitarias

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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 Occ — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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