Pain Clinical Trial
— ReViEEWOfficial title:
Effects of a Real-time Videoconference-based Exercise Program in Eldercare Workers: a Randomized Controlled Trial
Verified date | May 2024 |
Source | University of the Basque Country (UPV/EHU) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Caser Residencial Betharram | Hondarribia | Gipuzkoa |
Spain | Residencia Aspaldiko | Portugalete | Bizkaia |
Lead Sponsor | Collaborator |
---|---|
Ander Espin | Caser Residencial Betharram, Fundación Aspaldiko, Grupo Colisée, Grupo Servicios Sociales Integrados, Igurco Residencias Sociosanitarias |
Spain,
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
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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