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

Healthy Volunteers Clinical Trial

— ASTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051127
• Other study ID #: ISM-01-2013
• Secondary ID: 2012-0484
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: April 3, 2017

Study information

• Verified date: October 2018
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 3, 2017
• Est. primary completion date: October 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Stress
• Healthy Volunteers
• Sedentary Lifestyle
• Stress, Psychological

Intervention

Other:
• 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

Locations

Country	Name	City	State
Sweden	The Institute of Stress Medicine	Gothenburg	VGR

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Autonomic responses to acute psychosocial stress	Heart rate and blood pressure during and after the Trier Social Stress Test (TSST).	6 months after start of intervention
Other	Neuroendocrine and autonomic responses to exercise test		6 months after start of intervention
Primary	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	Cognitive function	Performance of the CNS Vital Signs (CNSVS) cognitive test battery.	6 months after start of intervention
Secondary	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
Secondary	Adrenocorticotropic hormone (ACTH) response to psychosocial stress	ACTH in plasma (pmol/L) after exposure to the TSST	6 months after start of intervention
Secondary	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

External Links

•   Webpage of the Institute of Stress Medicine