Effectiveness of a Supervised Hospital-based Physical Exercise

Anxiety Clinical Trial

Official title:

Effectiveness of a Supervised Hospital-based Physical Exercise Intervention to Reduce Stress in Health Care Professionals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04851795
• Other study ID #: PA01
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2022
• Source: Bioaraba Health Research Institute
• Contact: Raquel Cobos
• Phone: 945207935
• Email: raquel.coboscampos[@]osakidetza.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Stress, Psychological

Intervention

Other:
• supervised physical exercise sessions
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).
• unsupervised physical exercise
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.

Locations

Country	Name	City	State
Spain	Araba university hospital	Vitoria-gasteiz	Alava
Spain	Bioaraba Health Research Institute	Vitoria-gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Bioaraba Health Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	at six months
Secondary	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.	at six months
Secondary	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.	at six months
Secondary	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.	at six months
Secondary	Weight	Weight	at six months
Secondary	Body mass index	Body mass index	at six months
Secondary	lipid profile	Colesterol, HDL, LDL, triglycerides	at six months
Secondary	glycosylated hemoglobin	glycosylated hemoglobin	at six months
Secondary	work absenteeism	work absenteeism	at six months