Trial record 14 of 85 for:    Open Studies | "Stress, Psychological"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Vastra Gotaland Region
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region
ClinicalTrials.gov Identifier:
NCT02051127
First received: January 29, 2014
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Healthy Sedentary Individuals
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Sustainable Working Life With Reduced Stress Levels - The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.

Resource links provided by NLM:


Further study details as provided by Vastra Gotaland Region:

Primary Outcome Measures:
  • Cortisol responses to acute psychosocial stress. [ Time Frame: 6 months after start of intervention ] [ Designated as safety issue: No ]
    Serum cortisol (nmol/l) profile after exposure to the Trier Social Stress Test (TSST).


Secondary Outcome Measures:
  • Cognitive function [ Time Frame: 6 months after start of intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    DHEA(S) in serum (µmol/L) after exposure to the TSST


Other Outcome Measures:
  • Autonomic responses to acute psychosocial stress [ Time Frame: 6 months after start of intervention ] [ Designated as safety issue: No ]
    Heart rate and blood pressure during and after the Trier Social Stress Test (TSST).

  • Neuroendocrine and autonomic responses to exercise test [ Time Frame: 6 months after start of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
No Intervention: Control
Instructed to continue with their sedentary behavior for another 6 months.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051127

Contacts
Contact: Ingibjörg H Jonsdottir, Professor +46 31 3420716 ingibjorg.jonsdottir@vgregion.se
Contact: Anna Sjörs, PhD +46 31 3420719 anna.sjors@vgregion.se

Locations
Sweden
The Institute of Stress Medicine Recruiting
Gothenburg, VGR, Sweden, SE-413 19
Contact: Anna Sjörs, PhD    +46 31 3420719    anna.sjors@vgregion.se   
Contact: ASTI study       asti.studien@vgregion.se   
Principal Investigator: Ingibjörg H Jonsdottir, Professor         
Sponsors and Collaborators
Vastra Gotaland Region
Investigators
Principal Investigator: Ingibjörg H Jonsdottir, Professor Västra Götalandsregionen
  More Information

Additional Information:
No publications provided

Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02051127     History of Changes
Other Study ID Numbers: ISM-01-2013, 2012-0484
Study First Received: January 29, 2014
Last Updated: February 24, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Vastra Gotaland Region:
Exercise
Physical Fitness
Stress, Psychological
Cognition
Psychophysiology
Ergometry
Exercise Test
Sedentary Lifestyle

Additional relevant MeSH terms:
Fractures, Stress
Stress, Psychological
Fractures, Bone
Wounds and Injuries
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014