Condition category
Not Applicable
Date applied
04/05/2015
Date assigned
29/05/2015
Last edited
29/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Stress is a general term to describe the feeling of being under too much pressure. Feelings of stress may be triggered by the demands of daily life, such as being very busy at work or struggling with money worries. Stress may also arise as a result of important life events. Common symptoms of stress include sleeping problems, loss of appetite and difficulty concentrating. A number of techniques have been shown to help people manage their stress levels more effectively, including learning relaxation techniques and participating in exercise. The aim of this study is to compare different strategies for stress reduction and see how well they work to reduce feelings of stress in healthy adults. This study will test whether combining physical activity with relaxation techniques works better to relieve stress than carrying out relaxation techniques alone.

Who can participate?
Healthy adults currently employed.

What does the study involve?
Participants visit a thermal spa on 4 study days for approximately 2 hours at a time. All participants complete 4 different stress-relieving treatments in random order. Treatment 1 involves 30 minutes gentle walking combined with 20 minutes resting. Treatment 2 involves 30 minutes gentle walking combined with 20 minutes balneotherapy (bathing therapy). Treatment 3 involves combined relaxation (30 minutes resting and 20 minutes balneotherapy). Treatment 4 involves 60 minutes of resting only. All treatments are carried out in small groups of approximately 10 people and last for one hour. Before and after each treatment participants are asked to give a saliva sample. Participants are also asked to complete a short questionnaire and have their blood pressure taken. On one occasion participants are asked to take their own saliva sample in the morning. On the first study day participants are asked to complete a 30 minute general questionnaire.

What are the possible benefits and risks of participating?
Participants will benefit from experiencing several ways to reduce stress that can be used in daily life. Participants will learn about their own personal study results and which treatments worked best for them. On all four study days participants may stay at the thermal bath for free. In addition, participants will receive a voucher for two more visits once the study ends. The results of this study will help provide information important to the field of stress reduction and health. There are no risks associated with participating in this study.

Where is the study run from?
Medical University of Graz (Austria)

When is the study starting and how long is it expected to run for?
January 2012 to May 2013

Who is funding the study?
Regional Tourism Association Styrian Thermal Region (Tourismusregionalverband Steirisches Thermenland (Thermenland Styria)) (Austria)

Who is the main contact?
1. Dr F Matzer (scientific)
franziska.matzer@medunigraz.at
2. Dr E Nagele (scientific)
eva.nagele@medunigraz.at

Trial website

Contact information

Type

Scientific

Primary contact

Dr Franziska Matzer

ORCID ID

Contact details

Auenbruggerplatz 2/8
Graz
8036
Austria
+43 316 385 83039
franziska.matzer@medunigraz.at

Type

Scientific

Additional contact

Dr Eva Nagele

ORCID ID

Contact details

Medical University of Graz
Department of Obstetrics and Gynaecology
Auenbruggerplatz 14
Graz
8036
Austria
+43 316 3803306
eva.nagele@medunigraz.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

One hour time for stress reduction: combining physical activity and relaxation - a randomised controlled trial in healthy adults

Acronym

Study hypothesis

1. Is combining physical activity and relaxation a beneficial strategy for stress reduction in comparison to relaxation only?
2. Do participants with a high versus low stress level benefit from these strategies in a different manner?

Ethics approval

Ethics Committee of the Medical University of Graz, 15/06/2012, ref: IRB00002556.

Study design

A single-centred interventional study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Stress in healthy adults.

Intervention

Participants complete four different stress-relieving interventions lasting one hour each in random sequence:
1. 30 min moderate physical activity (supervised walking across a fixed, flat route at approx. 5-6 km/h) combined with 20 min resting (in a deckchair)
2. 30 min moderate physical activity combined with 20 min balneotherapy (bathing therapy in 36°C water)
3. combined relaxation (30 min resting and 20 min balneotherapy)
4. 60 min resting only
All methods for stress reduction will be conducted in groups averaging 10 persons. Participants will be instructed and supervised by the study personnel (medical doctors and clinical psychologists).

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

1. Salivary cortisol: saliva samples will be collected before intervention, then again one hour later on each study day
2. Blood pressure: measurements will be taken before and after intervention on each study day
3. State of mood: will be measured before and after intervention on each study day using the Multidimensional Mood State Questionnaire (MDBF), a validated multidimensional measurement for mood. Three bipolar dimensions are measured: (1) good mood - bad mood, (2) alertness – tiredness and (3) calmness – restlessness
4. Subjective relaxation: participants’ actual level of subjective relaxation will be measured before and after intervention on each study day using a rating scale (1-10) with 1 indicating no relaxation and 10 indicating high relaxation

Secondary outcome measures

1. Individual stress levels and bodily complaints will be measured using three validated questionnaires at study entry: Hamburger Burnout Inventory (HBI), the Trier Inventory for the Assessment of Chronic Stress (TICS), and the health complaints list (BL)
2. Cortisol awakening response measurement: participants will collect saliva samples directly after waking up in the morning on the second study day

Overall trial start date

02/01/2012

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. German-speaking
2. Healthy men and women
3. Currently employed
4. Aged 30-60

Participant type

Healthy volunteer

Age group

Other

Gender

Both

Target number of participants

81

Participant exclusion criteria

1. Participants diagnosed with any diseases
2. Participants currently taking medication that influences blood pressure and/or cortisol levels (e.g. rheumatic or cardiovascular diseases, Morbus Cushing, hypertensive medication)
3. Pregnancy or lactation period

Recruitment start date

15/08/2012

Recruitment end date

06/11/2012

Locations

Countries of recruitment

Austria

Trial participating centre

Medical University of Graz
Department of Medical Psychology and Psychotherapy Auenbruggerplatz 2/8
Graz
8036
Austria

Sponsor information

Organisation

Medical University of Graz

Sponsor details

Department of Medical Psychology and Psychotherapy
Auenbruggerplatz 2/8
Graz
8036
Austria

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Regional Tourism Association Styrian Thermal Region (Tourismusregionalverband Steirisches Thermenland (Thermenland Styria)) (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish main results in a peer-reviewed research journal. Data will be presented at scientific congresses.

Intention to publish date

30/06/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes