- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02051127
The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function. (ASTI)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
VGR
-
Gothenburg, VGR, Sweden, SE-413 19
- the Institute of Stress Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-reported good health
- Sedentary
- Work or study at least 50%
Exclusion Criteria:
- Diabetes
- Cardiovascular disease
- Blood pressure > 140/90
- Psychiatric disease
- Anemia
- Medication with substances that could affect any of the outcome measures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
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
|
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
|
|
No Intervention: Control
Instructed to continue with their sedentary behavior for another 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
6 months after start of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive function
Time Frame: 6 months after start of intervention
|
Performance of the CNS Vital Signs (CNSVS) cognitive test battery.
|
6 months after start of intervention
|
|
Self-reported stress sensitivity and symptoms
Time Frame: 6 and 12 months after start of intervention
|
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).
|
6 and 12 months after start of intervention
|
|
Adrenocorticotropic hormone (ACTH) response to psychosocial stress
Time Frame: 6 months after start of intervention
|
ACTH in plasma (pmol/L) after exposure to the TSST
|
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
|
DHEA(S) in serum (µmol/L) after exposure to the TSST
|
6 months after start of the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Autonomic responses to acute psychosocial stress
Time Frame: 6 months after start of intervention
|
Heart rate and blood pressure during and after the Trier Social Stress Test (TSST).
|
6 months after start of intervention
|
|
Neuroendocrine and autonomic responses to exercise test
Time Frame: 6 months after start of intervention
|
6 months after start of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ingibjörg H Jonsdottir, Professor, Västra Götalandsregionen
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISM-01-2013
- 2012-0484 (Other Grant/Funding Number: FORTE)
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