Healthy VolunteersASTINCT02051127
The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.
A study testing Exercise in people with Healthy Volunteers and Sedentary Lifestyle, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
One of the biggest challenges of today is the high stress levels among employees in companies and organizations. Physical exercise may be an effective preventive measure for stress-related problems. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Sedentary Lifestyle
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to 3 Apr 2017
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-reported good health
- Sedentary
- Work or study at least 50%
Who cannot join
- Diabetes
- Cardiovascular disease
- Blood pressure > 140/90
- Psychiatric disease
- Anemia
- Medication with substances that could affect any of the outcome measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sustainable Working Life With Reduced Stress Levels - The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.
One of the biggest challenges of today is the high stress levels among employees in companies and organizations. Physical exercise may be an effective preventive measure for stress-related problems. This relatively simple and inexpensive action is believed to be important for increasing and maintaining work ability and reduce the cost of stress-related ill health in the workplace.
The aim is to investigate how regular physical exercise affects the individual's ability to mentally and physiologically cope with stress. Acute stress physiological responses are measured before and after a 6 -month intervention, where 100 untrained individuals are randomized to either regular physical exercise or a control group.
Read more
The hypothesis is that exercise leads to lesser activation of the individual's stress physiological systems and to an efficient physiological protection system. Mental ability to handle stress is also studied as well as possible effects on the brain's cognitive functions. From a work perspective, cognitive impairment due to high exposure to stress is a major problem leading to substantial costs in businesses and organizations as a result of reduced performance and production.
We believe that physical activity can alter and mitigate individual stress reactions. This study brings new knowledge that can contribute to increased motivation to prioritize physical activity in everyday life. The study could also provide evidence for businesses and organizations of the benefits of engaging in interventions and fitness initiatives to facilitate/enable increased physical activity in daily life for its employees. With an aging population, we are expected to work longer, which poses a challenge as the ability to manage stress and maintain cognitive abilities decline with age. For older employees, regular physical activity could be an important factor directly affecting the prospects for a sustainable working life.
- Conditions
- Healthy Volunteers, Sedentary Lifestyle
- Being tested
- Exercise
- Keywords
- Exercise, Physical Fitness, Stress, Psychological, Cognition, Psychophysiology, Ergometry, Exercise Test, Sedentary Lifestyle
- Medical subject headings
- Sedentary Behavior, Motor Activity, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Physical training Duration: 45-60 minutes Frequency: 3 times per week Intensity: mean heart rate > 75% of maximum heart rate determined by exercise test before start of the intervention
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Physical training Duration: 45-60 minutes Frequency: 3 times per week Intensity: mean heart rate > 75% of maximum heart rate determined by exercise test before start of the intervention Receives: Other: Exercise |
| Control | No intervention | Instructed to continue with their sedentary behavior for another 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol responses to acute psychosocial stress.
Serum cortisol (nmol/l) profile after exposure to the Trier Social Stress Test (TSST).
Measured: 6 months after start of intervention
Secondary outcomes (4)
Cognitive function
Performance of the CNS Vital Signs (CNSVS) cognitive test battery.
Measured: 6 months after start of intervention
Self-reported stress sensitivity and symptoms
Assessed with the Perceived Stress Scale (PSS), Coping Inventory for Stressful Situations (CISS), Shirom Melamed Burnout questionnaire (SMBQ), Hospital Anxiety and Depression scale (HAD) and Patient Health Questionnaire (PHQ-15).
Measured: 6 and 12 months after start of intervention
Adrenocorticotropic hormone (ACTH) response to psychosocial stress
ACTH in plasma (pmol/L) after exposure to the TSST
Measured: 6 months after start of intervention
Dehydroepiandrostreone (DHEA) and dehydroepiandrosterone sulfate (DHEAS) response to psychosocial stress
DHEA(S) in serum (µmol/L) after exposure to the TSST
Measured: 6 months after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2013
- Primary completion25 Oct 2016
- Study completion3 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ingibjörg H Jonsdottir, Professor, Principal investigator, Västra Götalandsregionen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051127
- Sponsor's protocol ID
- ISM-01-2013
- Other IDs
- 2012-0484
- Acronym
- ASTI
- Status last verified
- Oct 2018
- First submitted
- 29 Jan 2014
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Arvidson E, Dahlman AS, Borjesson M, Gullstrand L, Jonsdottir IH. The effects of exercise training on hypothalamic-pituitary-adrenal axis reactivity and autonomic response to acute stress-a randomized controlled study. Trials. 2020 Oct 27;21(1):888. doi: 10.1186/s13063-020-04803-3.
PubMed 33109273
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Working Life With Reduced Stress Levels - The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.
- ClinicalTrials.gov ID
- NCT02051127
- Acronym / sponsor ID
- ASTI / ISM-01-2013
- Conditions
- Healthy Volunteers, Sedentary Lifestyle
- Keywords
- Exercise, Physical Fitness, Stress, Psychological, Cognition, Psychophysiology, Ergometry, Exercise Test, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Jan 2013 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
One of the biggest challenges of today is the high stress levels among employees in companies and organizations. Physical exercise may be an effective preventive measure for stress-related problems. This relatively simple and inexpensive action is believed to be important for increasing and maintaining work ability and reduce the cost of stress-related ill health in the workplace.
The aim is to investigate how regular physical exercise affects the individual's ability to mentally and physiologically cope with stress. Acute stress physiological responses are measured before and after a 6 -month intervention, where 100 untrained individuals are randomized to either regular physical exercise or a control group.
The hypothesis is that exercise leads to lesser activation of the individual's stress physiological systems and to an efficient physiological protection system. Mental ability to handle stress is also studied as well as possible effects on the brain's cognitive functions. From a work perspective, cognitive impairment due to high exposure to stress is a major problem leading to substantial costs in businesses and organizations as a result of reduced performance and production.
We believe that physical activity can alter and mitigate individual stress reactions. This study brings new knowledge that can contribute to increased motivation to prioritize physical activity in everyday life. The study could also provide evidence for businesses and organizations of the benefits of engaging in interventions and fitness initiatives to facilitate/enable increased physical activity in daily life for its employees. With an aging population, we are expected to work longer, which poses a challenge as the ability to manage stress and maintain cognitive abilities decline with age. For older employees, regular physical activity could be an important factor directly affecting the prospects for a sustainable working life.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExercisePhysical training Duration: 45-60 minutes Frequency: 3 times per week Intensity: mean heart rate > 75% of maximum heart rate determined by exercise test before start of the intervention |
| Control | No intervention | –Instructed to continue with their sedentary behavior for another 6 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Self-reported good health
- Sedentary
- Work or study at least 50%
Key exclusion criteria (6 listed)
- Diabetes
- Cardiovascular disease
- Blood pressure > 140/90
- Psychiatric disease
- Anemia
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 |
|---|---|---|
| ExercisePhysical training Duration: 45-60 minutes Frequency: 3 times per week Intensity: mean heart rate > 75% of maximum heart rate determined by exercise test before start of the intervention | Other | Exercise |
Primary outcome
Cortisol responses to acute psychosocial stress.
Time frame: 6 months after start of intervention
Serum cortisol (nmol/l) profile after exposure to the Trier Social Stress Test (TSST).
4 secondary outcomes
Cognitive function
Time frame: 6 months after start of intervention
Self-reported stress sensitivity and symptoms
Time frame: 6 and 12 months after start of intervention
Adrenocorticotropic hormone (ACTH) response to psychosocial stress
Time frame: 6 months after start of intervention
Dehydroepiandrostreone (DHEA) and dehydroepiandrosterone sulfate (DHEAS) response to psychosocial stress
Time frame: 6 months after start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 33109273Arvidson E, Dahlman AS, Borjesson M, Gullstrand L, Jonsdottir IH. The effects of exercise training on hypothalamic-pituitary-adrenal axis reactivity and autonomic response to acute stress-a randomized controlled study. Trials. 2020 Oct 27;21(1):888. doi: 10.1186/s13063-020-04803-3.
- Webpage of the Institute of Stress MedicineLink provided by the sponsor.
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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.
Ingibjörg H Jonsdottir, Professor principal investigator
Västra Götalandsregionen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy Volunteers and Sedentary Lifestyle, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol responses to acute psychosocial stress. (time frame: 6 months after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02051127, which also lists 1 linked publication.
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 11 Oct 2018.