Affect Clinical Trial
Official title:
Affective Responses in Mountain Hiking: A Randomized Controlled Trial Focusing on Differences Between Indoor and Outdoor Activity
| NCT number | NCT02853760 |
| Other study ID # | ARMH |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2015 |
| Est. completion date | October 2015 |
| Verified date | May 2022 |
| Source | Universitaet Innsbruck |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Using a within-subject design, 42 healthy participants were randomly exposed to three different conditions: outdoor mountain hiking, indoor treadmill walking, and sedentary control situation (3.5 hours each). Measures included the Feeling Scale, Felt Arousal Scale and a Mood Survey Scale. Univariate ANOVAs were used to analyse differences between the conditions.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Universitaet Innsbruck | Paracelsus Medical University |
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. eCollect — View Citation
Niedermeier M, Grafetstätter 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). pii: E905. doi: 10.3390/ijerph14080905. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline Subscales of Mood Survey Scale at 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 | |
| Primary | Change From Baseline Feeling Scale at 3 Hours | 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 | |
| Primary | Change From Baseline Felt Arousal Scale at 3 Hours | 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 | Change From Baseline Blood Pressure at 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 | |
| Secondary | Change From Baseline Heart Rate Variability at 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 | |
| Secondary | Change From Baseline Cortisol at 3 Hours (Saliva Sampling) | 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 |
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