Stress reduction in healthy adults: combining physical activity and relaxation

ISRCTN	ISRCTN18122954
DOI	https://doi.org/10.1186/ISRCTN18122954
Protocol serial number	N/A
Sponsor	Medical University of Graz
Funder	Regional Tourism Association Styrian Thermal Region (Tourismusregionalverband Steirisches Thermenland (Thermenland Styria)) (Austria)

Submission date: 04/05/2015
Registration date: 29/05/2015
Last edited: 18/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Franziska Matzer
Scientific

Auenbruggerplatz 2/8
Graz
8036
Austria

Phone	+43 316 385 83039
Email	franziska.matzer@medunigraz.at

Dr Eva Nagele
Scientific

Medical University of Graz
Department of Obstetrics and Gynaecology
Auenbruggerplatz 14
Graz
8036
Austria

Phone	+43 316 3803306
Email	eva.nagele@medunigraz.at

Study information

Primary study design	Interventional
Study design	A single-centred interventional study
Secondary study design	Randomised cross over trial
Study type	Participant information sheet
Scientific title	One hour time for stress reduction: combining physical activity and relaxation - a randomised controlled trial in healthy adults
Study objectives	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(s)	Ethics Committee of the Medical University of Graz, 15/06/2012, ref: IRB00002556.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/05/2013

Eligibility

Participant type(s)	Healthy volunteer
Age group	Other
Sex	All
Target sample size at registration	81
Key inclusion criteria	1. German-speaking 2. Healthy men and women 3. Currently employed 4. Aged 30-60
Key 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
Date of first enrolment	15/08/2012
Date of final enrolment	06/11/2012

Locations

Countries of recruitment

Austria

Study participating centre

Medical University of Graz

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

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2018	18/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/01/2019: Publication reference added