Stress, PsychologicalNCT04851795
Effectiveness of a Supervised Hospital-based Physical Exercise
A study testing supervised physical exercise sessions and unsupervised physical exercise in people with Stress, Psychological and Anxiety, run by Bioaraba Health Research Institute at 2 sites in Spain.
Trial summary
To assess if physical activity is effective in reducing stress and anxiety in healthcare professionals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress, Psychological, Anxiety
- What is being tested?
- supervised physical exercise sessions and unsupervised physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Araba university hospital
Vitoria-Gasteiz, Alava, 01009
RAQUEL COBOS, phD, +34945207935, raquel.coboscampos@osakidetza.eus
- Not yet recruiting
Bioaraba Health Research Institute
Vitoria-Gasteiz, Alava, 01009
Raquel Cobos, raquel.coboscampos@osakidetza.eus
About this study
Official title: Effectiveness of a Supervised Hospital-based Physical Exercise Intervention to Reduce Stress in Health Care Professionals
To assess if physical activity is effective in reducing stress and anxiety in healthcare professionals.
Read the 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).
- Conditions
- Stress, Psychological, Anxiety
- Being tested
- supervised physical exercise sessions, unsupervised physical exercise
- Medical subject headings
- Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supervised physical exercise sessionsOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: unsupervised physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at six months
Secondary outcomes (9)
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.
Measured: at six months
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.
Measured: at six months
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.
Measured: at six months
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.
Measured: at six months
Weight
Weight
Measured: at six months
Body mass index
Body mass index
Measured: at six months
lipid profile
Colesterol, HDL, LDL, triglycerides
Measured: at six months
glycosylated hemoglobin
glycosylated hemoglobin
Measured: at six months
work absenteeism
work absenteeism
Measured: at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Jun 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioaraba Health Research Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851795
- Sponsor's protocol ID
- PA01
- Status last verified
- Jul 2022
- First submitted
- 15 Apr 2021
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Supervised Hospital-based Physical Exercise Intervention to Reduce Stress in Health Care Professionals
- ClinicalTrials.gov ID
- NCT04851795
- Acronym / sponsor ID
- PA01
- Conditions
- Stress, Psychological, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bioaraba Health Research InstituteResearch network
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supervised physical exercise sessions | Experimental | Other: supervised physical exercise sessionsParticipants 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 sessions | Other | Other: unsupervised physical exerciseFor 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supervised physical exercise sessionsParticipants 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 exerciseFor 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 sessions |
Primary outcome
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.
9 secondary outcomes
Goldberg anxiety questionnaire
Time frame: at six months
Short Form Survey_Mental health
Time frame: at six months
Short Form Survey_Physical condition
Time frame: at six months
Ruffier index
Time frame: at six months
Weight
Time frame: at six months
Body mass index
Time frame: at six months
lipid profile
Time frame: at six months
glycosylated hemoglobin
Time frame: at six months
work absenteeism
Time frame: at six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supervised physical exercise sessions and unsupervised physical exercise in people with Stress, Psychological and Anxiety, run by Bioaraba Health Research Institute at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raquel Cobos (945207935, raquel.coboscampos@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress (time frame: at six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2022.