The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.

Study Overview
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Brief Summary
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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.

Official Title
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Sustainable Working Life With Reduced Stress Levels - The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.

Conditions
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Healthy Volunteers, Sedentary Lifestyle

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>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 | Other: Exercise<br>* 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<br>|
| No Intervention: Control<br>Instructed to continue with their sedentary behavior for another 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol responses to acute psychosocial stress. | 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 | Performance of the CNS Vital Signs (CNSVS) cognitive test battery. | 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). | 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 | 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 | 6 months after start of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Fitness, Stress, Psychological, Exercise, Cognition, Psychophysiology, Ergometry, Exercise Test, Sedentary Lifestyle