NCT04851795

Brief Summary

To assess if physical activity is effective in reducing stress and anxiety in healthcare professionals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

1.5 years

First QC Date

April 15, 2021

Last Update Submit

July 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress

    Perceived stress scale-PSS. PSS scores are obtained by inverting the responses (e.g. 0 = 4, 1 = 3, 2 = 2, 3 = 1 and 4 = 0) to the four positive items (items 4, 5, 7 and 8) and then adding up all the points on the scale.

    at six months

Secondary Outcomes (9)

  • Goldberg anxiety questionnaire

    at six months

  • Short Form Survey_Mental health

    at six months

  • Short Form Survey_Physical condition

    at six months

  • Ruffier index

    at six months

  • Weight

    at six months

  • +4 more secondary outcomes

Study Arms (2)

supervised physical exercise sessions

EXPERIMENTAL

Participants assigned to the supervised exercise group will perform a supervised routine of approximately 30 minutes, 2 days per week (Monday and Wednesday at the Txagorritxu hospital, and Tuesday and Thursday at the Santiago hospital from 7:15 to 7:45 and from 15:15 to 15:45).

Other: supervised physical exercise sessions

unsupervised physical exercise sessions

OTHER

For the non-supervised group, we will propose climbing the stairs from floor 0 to floor 7 three times during the working day and doing planks and stretching exercises outside of work. For the latter, an educational session will be given at the beginning of the study to explain how to perform them correctly.

Other: unsupervised physical exercise

Interventions

Participants assigned to the supervised exercise group will perform a supervised routine of approximately 30 minutes, 2 days per week (Monday and Wednesday at the Txagorritxu hospital, and Tuesday and Thursday at the Santiago hospital from 7:15 to 7:45 and from 15:15 to 15:45).

supervised physical exercise sessions

For the non-supervised group, we will propose climbing the stairs from floor 0 to floor 7 three times during the working day and doing planks and stretching exercises outside of work. For the latter, an educational session will be given at the beginning of the study to explain how to perform them correctly.

unsupervised physical exercise sessions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Apt for sports practice after review by the corresponding health professional of the Occupational Health Service,
  • Motivation for sports practice (could be self-referred or on an EVA scale from a score for example of 6) being 0 not motivated at all and 10 totally motivated.
  • One could extrapolate the score limits of the EVA scale pain no motivation=0; mild motivation=1,2; moderate=3-5; high from 6.
  • Professionals whose working day does not coincide with the hours during which the sessions are to be given.
  • Professionals who do not work shifts.

You may not qualify if:

  • Any type of contraindication for sports practice (Annex I),
  • Staff who, due to their activity, have greater mobility in the hospital (orderlies).
  • Osteoarticular injuries, cervical and lumbalgias.
  • Withdrawal criteria
  • Within the intervention group - absence maximum two weeks to the exercises. This will not be taken into account during the summer period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Araba university hospital

Vitoria-Gasteiz, Alava, 01009, Spain

RECRUITING

Bioaraba Health Research Institute

Vitoria-Gasteiz, Alava, 01009, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 20, 2021

Study Start

June 1, 2021

Primary Completion

December 1, 2022

Study Completion

July 1, 2023

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations