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Effectiveness of a Supervised Hospital-based Physical Exercise

Primary Purpose

Stress, Psychological, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
supervised physical exercise sessions
unsupervised physical exercise
Sponsored by
Bioaraba Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Araba university hospitalRecruiting
  • Bioaraba Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

supervised physical exercise sessions

unsupervised physical exercise sessions

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Goldberg anxiety questionnaire
Goldberg anxiety questionnaire. This questionnaire has a total of 9 items. A score greater than or equal to 4 is indicative of anxiety.
Short Form Survey_Mental health
Mental component of the SF12 questionnaire. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (worst health status for that dimension) to 100 (best health status). The number of response options ranges from three to six, depending on the item.
Short Form Survey_Physical condition
Physical component of the SF12 questionnaire. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (worst health status for that dimension) to 100 (best health status). The number of response options ranges from three to six, depending on the item.
Ruffier index
The Ruffier test is a test performed to measure short-term aerobic endurance and cardiac recovery capacity, and therefore the level of physical fitness in individuals. An index below 0 indicates a good physical condition. Its average value is between 5 and 10. Above 10 the patient is considered to have a poor adaptation to exertion.
Weight
Weight
Body mass index
Body mass index
lipid profile
Colesterol, HDL, LDL, triglycerides
glycosylated hemoglobin
glycosylated hemoglobin
work absenteeism
work absenteeism

Full Information

First Posted
April 15, 2021
Last Updated
July 14, 2022
Sponsor
Bioaraba Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04851795
Brief Title
Effectiveness of a Supervised Hospital-based Physical Exercise
Official Title
Effectiveness of a Supervised Hospital-based Physical Exercise Intervention to Reduce Stress in Health Care Professionals
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioaraba Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess if physical activity is effective in reducing stress and anxiety in healthcare professionals.
Detailed Description
To assess if physical activity is effective in reducing stress and anxiety in healthcare professionals. To evaluate if physical activity is effective in improving the physical and mental state of health care professionals and improving several blood parameters (lipid profile and blood glucose).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
supervised physical exercise sessions
Arm Type
Experimental
Arm Description
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).
Arm Title
unsupervised physical exercise sessions
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
supervised physical exercise sessions
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
unsupervised physical exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived Stress
Description
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.
Time Frame
at six months
Secondary Outcome Measure Information:
Title
Goldberg anxiety questionnaire
Description
Goldberg anxiety questionnaire. This questionnaire has a total of 9 items. A score greater than or equal to 4 is indicative of anxiety.
Time Frame
at six months
Title
Short Form Survey_Mental health
Description
Mental component of the SF12 questionnaire. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (worst health status for that dimension) to 100 (best health status). The number of response options ranges from three to six, depending on the item.
Time Frame
at six months
Title
Short Form Survey_Physical condition
Description
Physical component of the SF12 questionnaire. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale ranging from 0 (worst health status for that dimension) to 100 (best health status). The number of response options ranges from three to six, depending on the item.
Time Frame
at six months
Title
Ruffier index
Description
The Ruffier test is a test performed to measure short-term aerobic endurance and cardiac recovery capacity, and therefore the level of physical fitness in individuals. An index below 0 indicates a good physical condition. Its average value is between 5 and 10. Above 10 the patient is considered to have a poor adaptation to exertion.
Time Frame
at six months
Title
Weight
Description
Weight
Time Frame
at six months
Title
Body mass index
Description
Body mass index
Time Frame
at six months
Title
lipid profile
Description
Colesterol, HDL, LDL, triglycerides
Time Frame
at six months
Title
glycosylated hemoglobin
Description
glycosylated hemoglobin
Time Frame
at six months
Title
work absenteeism
Description
work absenteeism
Time Frame
at six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raquel Cobos
Phone
945207935
Email
raquel.coboscampos@osakidetza.eus
Facility Information:
Facility Name
Araba university hospital
City
Vitoria-gasteiz
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RAQUEL COBOS, phD
Phone
+34945207935
Email
raquel.coboscampos@osakidetza.eus
Facility Name
Bioaraba Health Research Institute
City
Vitoria-gasteiz
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Cobos
Email
raquel.coboscampos@osakidetza.eus

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of a Supervised Hospital-based Physical Exercise

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