Overview

This trial is active, not recruiting.

Conditions healthy volunteers, sedentary lifestyle
Treatment exercise
Sponsor Vastra Gotaland Region
Start date January 2013
End date November 2016
Trial size 119 participants
Trial identifier NCT02051127, 2012-0484, ISM-01-2013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
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
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)
Instructed to continue with their sedentary behavior for another 6 months.

Primary Outcomes

Measure
Cortisol responses to acute psychosocial stress.
time frame: 6 months after start of intervention

Secondary Outcomes

Measure
Cognitive function
time frame: 6 months after start of intervention
Self-reported stress sensitivity and symptoms
time frame: 6 and 12 months after start of intervention
Adrenocorticotropic hormone (ACTH) response to psychosocial stress
time frame: 6 months after start of intervention
Dehydroepiandrostreone (DHEA) and dehydroepiandrosterone sulfate (DHEAS) response to psychosocial stress
time frame: 6 months after start of the intervention

Eligibility Criteria

Male or female participants from 20 years up to 50 years old.

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

Additional Information

Official title Sustainable Working Life With Reduced Stress Levels - The Effects of Physical Training on Physiological and Psychological Stress-reactions and Cognitive Function.
Principal investigator Ingibjörg H Jonsdottir, Professor
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Vastra Gotaland Region.