- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04851795
Effectiveness of a Supervised Hospital-based Physical Exercise
Effectiveness of a Supervised Hospital-based Physical Exercise Intervention to Reduce Stress in Health Care Professionals
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raquel Cobos
- Phone Number: 945207935
- Email: raquel.coboscampos@osakidetza.eus
Study Locations
-
-
Alava
-
Vitoria-gasteiz, Alava, Spain, 01009
- Recruiting
- Araba University Hospital
-
Contact:
- RAQUEL COBOS, phD
- Phone Number: +34945207935
- Email: raquel.coboscampos@osakidetza.eus
-
Vitoria-gasteiz, Alava, Spain, 01009
- Not yet recruiting
- Bioaraba Health Research Institute
-
Contact:
- Raquel Cobos
- Email: raquel.coboscampos@osakidetza.eus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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).
|
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: unsupervised 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress
Time Frame: at six months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goldberg anxiety questionnaire
Time Frame: at six months
|
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
|
|
Short Form Survey_Mental health
Time Frame: at six months
|
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
|
|
Short Form Survey_Physical condition
Time Frame: at six months
|
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
|
|
Ruffier index
Time Frame: at six months
|
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
|
|
Weight
Time Frame: at six months
|
Weight
|
at six months
|
|
Body mass index
Time Frame: at six months
|
Body mass index
|
at six months
|
|
lipid profile
Time Frame: at six months
|
Colesterol, HDL, LDL, triglycerides
|
at six months
|
|
glycosylated hemoglobin
Time Frame: at six months
|
glycosylated hemoglobin
|
at six months
|
|
work absenteeism
Time Frame: at six months
|
work absenteeism
|
at six months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress, Psychological
-
University of Thi-QarCompletedPsychological Stress | Academic StressIraq
-
Amsterdam UMC, location VUmcRigshospitalet, Denmark; Universitätsklinikum Hamburg-EppendorfNot yet recruitingStress | Stress and Burnout | Stress BiomarkersGermany, Denmark
-
New York State Psychiatric InstituteJohnson & JohnsonCompletedPsychological Stress in PregnancyUnited States
-
Hacettepe UniversityCompletedStressTurkey (Türkiye)
-
Baylor UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedAcute Psychological StressUnited States
-
Örebro University, SwedenCompletedPsychological Stress Due to SkydivingSweden
-
Universität Duisburg-EssenRecruitingStress | Burnout | Burnout Syndrome | Stress ResilienceGermany
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
Amrita Vishwa VidyapeethamAmrita Viswa VidyapeethamCompletedCovid Related Psychological StressIndia
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Not yet recruitingPsychological Stress | Social Interaction
Clinical Trials on supervised physical exercise sessions
-
University Hospital Center of MartiniqueUnknownCardiovascular DiseaseGuadeloupe, Martinique
-
University of Texas Southwestern Medical CenterCancer Prevention Research Institute of TexasCompleted
-
United Arab Emirates UniversityMohammed Bin Rashid University of Medicine and Health SciencesCompletedCardiovascular Risk Factor | Pre Diabetes | High Blood Pressure | Elevated LDL CholesterolUnited Arab Emirates
-
Puerta de Hierro University HospitalWithdrawnCancer Patients | HospitalizedSpain
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloUnknownSystemic Lupus ErythematosusBrazil
-
University of SalamancaNot yet recruitingCancer | Exercise | Multiple Myeloma (MM)
-
McGill UniversityCanadian Institutes of Health Research (CIHR)CompletedChronic Low Back Pain (CLBP)Canada
-
Universidad Politecnica de MadridUnknown
-
University of Illinois at Urbana-ChampaignCompletedQuality of Life | Physical Activity | Cognitive Impairment | Cancer of the ProstateUnited States
-
University of Kansas Medical CenterCompletedObesity | Sarcopenia | Compensated CirrhosisUnited States