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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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11 February 2019 |
Main ID: |
ISRCTN18122954 |
Date of registration:
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29/05/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Stress reduction in healthy adults: combining physical activity and relaxation
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Scientific title:
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One hour time for stress reduction: combining physical activity and relaxation - a randomised controlled trial in healthy adults |
Date of first enrolment:
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15/08/2012 |
Target sample size:
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81 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN18122954 |
Study type:
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Interventional |
Study design:
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A single-centred interventional study (Quality of life)
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Name:
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Franziska
Matzer |
Address:
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Auenbruggerplatz 2/8
8036
Graz
Austria |
Telephone:
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+43 316 385 83039 |
Email:
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franziska.matzer@medunigraz.at |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. German-speaking 2. Healthy men and women 3. Currently employed 4. Aged 30-60
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stress in healthy adults. Not Applicable
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Intervention(s)
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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).
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Regional Tourism Association Styrian Thermal Region (Tourismusregionalverband Steirisches Thermenland (Thermenland Styria)) (Austria)
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Ethics review
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Status:
Approval date:
Contact:
Ethics Committee of the Medical University of Graz, 15/06/2012, ref: IRB00002556.
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/05/2013 |
URL:
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