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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 ol

Detailed Summary:
Sponsor: Vastra Gotaland Region

Current 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).


Original Primary Outcome: Neuroendocrine responses to acute psychosocial stress. [ Time Frame: 6 months after start of intervention ]

Cortisol, Adrenocorticotropic Hormone (ACTH) Dehydroepiandrosterone (DHEA) and Dehydroepiandrosterone Sulfate (DHEA-S) responses to the Trier Social Stress Test (TSST).


Current Secondary Outcome:

  • Cognitive function [ Time Frame: 6 months after start of intervention ]
    Performance of the CNS Vital Signs (CNSVS) cognitive test battery.
  • 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).
  • 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
  • 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


Original Secondary Outcome:

  • Cognitive function [ Time Frame: 6 months after start of intervention ]
    Performance of the CNS Vital Signs (CNSVS) cognitive test battery.
  • 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).


Information By: Vastra Gotaland Region

Dates:
Date Received: January 29, 2014
Date Started: January 2013
Date Completion: March 2017
Last Updated: November 1, 2016
Last Verified: May 2016