NCT05050526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

2.6 years

First QC Date

September 9, 2021

Last Update Submit

May 23, 2024

Conditions

Keywords

EldercareCaregiverExerciseTele-healthMusculoskeletal disordersMental disordersAbsenteeismWork abilityWork performance

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (14)

  • Analgesic medication consumption frequency

    At baseline and at 12-week and 48-week follow-ups

  • 5-repetition sit-to-stand test

    At baseline and at 12-week and 48-week follow-ups

  • Kneeling push-up test

    At baseline and at 12-week and 48-week follow-ups

  • Shirado-Ito trunk flexor endurance test

    At baseline and at 12-week and 48-week follow-ups

  • Subjective Happiness scale

    At baseline and at 12-week and 48-week follow-ups

  • +9 more secondary outcomes

Study Arms (2)

Exercise program

EXPERIMENTAL

Participants in the experimental group will take part in a 12-week exercise program.

Behavioral: Real-time videoconference-based Exercise program

Control

NO INTERVENTION

Participants in the control group will not receive any intervention.

Interventions

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.

Exercise program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Professional eldercare workers with ≥3 months of experience in the profession
  • Employment contract at least until the anticipated date of study end

You may not qualify if:

  • Pregnancy
  • Contraindication to exercise according to the American College of Sports Medicine Guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Residencia Aspaldiko

Portugalete, Bizkaia, 48920, Spain

Location

Caser Residencial Betharram

Hondarribia, Gipuzkoa, 20280, Spain

Location

Related Publications (4)

  • 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.

    PMID: 37280584BACKGROUND
  • 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 Occup Rehabil. 2025 Mar;35(1):66-77. doi: 10.1007/s10926-024-10182-2. Epub 2024 Apr 17.

  • Espin A, Rodriguez-Larrad A, Ruiz-Fernandez A, Martin-Perez A, Fernandez-Gutierrez N, Andersen LL, Irazusta J. Predictors of response to physical exercise for low back pain: a secondary analysis of the ReViEEW trial. Musculoskelet Sci Pract. 2026 Feb;81:103465. doi: 10.1016/j.msksp.2025.103465. Epub 2025 Dec 3.

  • Espin A, Irazusta J, Urquiza M, Ruiz-Fernandez A, Latorre Erezuma U, Collado Torres L, Andersen LL, Rodriguez-Larrad A. Videoconference-Supervised Exercise for Low Back Pain in Eldercare Workers: One-Year Follow-up of the ReViEEW Randomized Controlled Trial. J Occup Environ Med. 2025 Oct 1;67(10):e720-e728. doi: 10.1097/JOM.0000000000003474. Epub 2025 Jun 2.

Related Links

MeSH Terms

Conditions

PainMental DisordersMotor ActivityMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Ander Espin, PhD Student

    University of the Basque Country (UPV/EHU)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Predoctoral Researcher

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 20, 2021

Study Start

October 1, 2021

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Locations