- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02853760
Affective Responses in Mountain Hiking
Affective Responses in Mountain Hiking: A Randomized Controlled Trial Focusing on Differences Between Indoor and Outdoor Activity
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- voluntary participation
Exclusion Criteria:
- pregnancy
- breast-feeding
- chronic or acute diseases (already existing or diagnosed during the study)
- age below 18 and above 70 years
- unable to be physically active assessed by the Physical Activity Readiness Questionnaire (Shephard, Thomas, & Weller, 1991)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Outdoor mountain hiking (M)
First part of the intervention: an uphill walking phase on single trails and forest roads in a sparse forest with view on the mountainous region around Innsbruck for 6 km in around 1.5 hours together with the test leader. Regarding the walking intensity, the participants were instructed to choose a "brisk without overspending" pace (average speed: 4 km/h). In the second part of the intervention, the participants were walking downhill on the same track for around 70 minutes back to the starting point to respond to the post-test (average speed: 5.2 km/h). |
|
Active Comparator: Indoor treadmill walking (T)
To ensure that all physical parameters were simultaneous to the outdoor mountain hiking condition, the distance, the difference in height, the average inclination of the track, and the time needed for the outdoor mountain hiking situation were measured in a pilot study. First part: uphill walking, inclination: 10%, time: 1.5 hours, and speed: 4 km/h (resulting in 600 m difference in height). In accordance to possible differences in outdoor speed, the participants were allowed to change the treadmill's speed in a small range (3.8 to 4.2 km/h) to adapt to the wording "brisk without overspending". Second part of the intervention contained 70 minutes of level walking on the same treadmills (5.2 km/h, 6km). |
|
No Intervention: Sedentary control condition (C)
The sedentary control situation was located in a quiet room at the university with access to computers.
The participants were allowed to use the computers, to read, and to talk, but had to remain in a sedentary position.
To control for possible differences in affective response due to the daytime, the sedentary control condition contained the same timing of the measurements than the intervention condition.
Sociodemographic data were collected for 5 to 10 minutes in this condition using a web-based questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Subscales of Mood Survey Scale at 3 Hours
Time Frame: baseline and 3 hours
|
Mood Survey Scale, min: 5, max: 25 higher score: better outcome All Outcome Measures are reported "per intervention", i.e., the data in Arms/Groups reflect the participants of the particular intervention.
|
baseline and 3 hours
|
Change From Baseline Feeling Scale at 3 Hours
Time Frame: baseline and 3 hours after baseline
|
Feeling Scale, min: -5, max: +5 higher score: better outcome All Outcome Measures are reported "per intervention", i.e., the data in Arms/Groups reflect the participants of the particular intervention.
|
baseline and 3 hours after baseline
|
Change From Baseline Felt Arousal Scale at 3 Hours
Time Frame: baseline and 3 hours after baseline
|
Felt Arousal Scale, min: 0, max: 6 higher score: better outcome All Outcome Measures are reported "per intervention", i.e., the data in Arms/Groups reflect the participants of the particular intervention.
|
baseline and 3 hours after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Blood Pressure at 3 Hours
Time Frame: baseline and 3 hours
|
All Outcome Measures are reported "per intervention", i.e., the data in Arms/Groups reflect the participants of the particular intervention.
|
baseline and 3 hours
|
Change From Baseline Heart Rate Variability at 3 Hours
Time Frame: baseline and 3 hours
|
All Outcome Measures are reported "per intervention", i.e., the data in Arms/Groups reflect the participants of the particular intervention.
|
baseline and 3 hours
|
Change From Baseline Cortisol at 3 Hours (Saliva Sampling)
Time Frame: baseline and 3 hours
|
All Outcome Measures are reported "per intervention", i.e., the data in Arms/Groups reflect the participants of the particular intervention.
|
baseline and 3 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Martin Kopp, Prof., martin.kopp@uibk.ac.at
Publications and helpful links
General Publications
- Niedermeier M, Einwanger J, Hartl A, Kopp M. Affective responses in mountain hiking-A randomized crossover trial focusing on differences between indoor and outdoor activity. PLoS One. 2017 May 16;12(5):e0177719. doi: 10.1371/journal.pone.0177719. eCollection 2017.
- Niedermeier M, Grafetstatter C, Hartl A, Kopp M. A Randomized Crossover Trial on Acute Stress-Related Physiological Responses to Mountain Hiking. Int J Environ Res Public Health. 2017 Aug 11;14(8):905. doi: 10.3390/ijerph14080905.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ARMH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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