The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function. (ASTI)
Primary Purpose
Healthy Volunteers, Sedentary Lifestyle
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Volunteers focused on measuring Exercise, Physical Fitness, Stress, Psychological, Cognition, Psychophysiology, Ergometry, Exercise Test, Sedentary Lifestyle
Eligibility Criteria
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
Sites / Locations
- The Institute of Stress Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Control
Arm Description
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
Instructed to continue with their sedentary behavior for another 6 months.
Outcomes
Primary Outcome Measures
Cortisol responses to acute psychosocial stress.
Serum cortisol (nmol/l) profile after exposure to the Trier Social Stress Test (TSST).
Secondary Outcome Measures
Cognitive function
Performance of the CNS Vital Signs (CNSVS) cognitive test battery.
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).
Adrenocorticotropic hormone (ACTH) response to psychosocial stress
ACTH in plasma (pmol/L) after exposure to the TSST
Dehydroepiandrostreone (DHEA) and dehydroepiandrosterone sulfate (DHEAS) response to psychosocial stress
DHEA(S) in serum (µmol/L) after exposure to the TSST
Full Information
NCT ID
NCT02051127
First Posted
January 29, 2014
Last Updated
October 10, 2018
Sponsor
Vastra Gotaland Region
1. Study Identification
Unique Protocol Identification Number
NCT02051127
Brief Title
The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.
Acronym
ASTI
Official Title
Sustainable Working Life With Reduced Stress Levels - The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
October 25, 2016 (Actual)
Study Completion Date
April 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Sedentary Lifestyle
Keywords
Exercise, Physical Fitness, Stress, Psychological, Cognition, Psychophysiology, Ergometry, Exercise Test, Sedentary Lifestyle
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Instructed to continue with their sedentary behavior for another 6 months.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Cortisol responses to acute psychosocial stress.
Description
Serum cortisol (nmol/l) profile after exposure to the Trier Social Stress Test (TSST).
Time Frame
6 months after start of intervention
Secondary Outcome Measure Information:
Title
Cognitive function
Description
Performance of the CNS Vital Signs (CNSVS) cognitive test battery.
Time Frame
6 months after start of intervention
Title
Self-reported stress sensitivity and symptoms
Description
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).
Time Frame
6 and 12 months after start of intervention
Title
Adrenocorticotropic hormone (ACTH) response to psychosocial stress
Description
ACTH in plasma (pmol/L) after exposure to the TSST
Time Frame
6 months after start of intervention
Title
Dehydroepiandrostreone (DHEA) and dehydroepiandrosterone sulfate (DHEAS) response to psychosocial stress
Description
DHEA(S) in serum (µmol/L) after exposure to the TSST
Time Frame
6 months after start of the intervention
Other Pre-specified Outcome Measures:
Title
Autonomic responses to acute psychosocial stress
Description
Heart rate and blood pressure during and after the Trier Social Stress Test (TSST).
Time Frame
6 months after start of intervention
Title
Neuroendocrine and autonomic responses to exercise test
Time Frame
6 months after start of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingibjörg H Jonsdottir, Professor
Organizational Affiliation
Västra Götalandsregionen
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Institute of Stress Medicine
City
Gothenburg
State/Province
VGR
ZIP/Postal Code
SE-413 19
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
33109273
Citation
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.
Results Reference
derived
Links:
URL
http://www.vgregion.se/stressmedicin
Description
Webpage of the Institute of Stress Medicine
Learn more about this trial
The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.
We'll reach out to this number within 24 hrs