<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03229434</url>
  </required_header>
  <id_info>
    <org_study_id>ARMH_2</org_study_id>
    <nct_id>NCT03229434</nct_id>
  </id_info>
  <brief_title>Mountain Hiking &amp; Environmental Influences</brief_title>
  <official_title>Effects of Mountain Hiking on Physiological and Psychological Health Parameters With Special Focus on the Influence of the Environment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaet Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Paracelsus Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaet Innsbruck</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a randomized crossover design, approximately 50 healthy participants will be randomly&#xD;
      exposed to outdoor mountain hiking (approximately 6 hours each) in two different areas: an&#xD;
      anthropogenically influenced area and in a widely pristine area.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 29, 2017</start_date>
  <completion_date type="Actual">November 1, 2017</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>pseudonymes</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Cortisol (Saliva Sampling) at 6 hours</measure>
    <time_frame>6 hours</time_frame>
    <description>Physiological response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline subscales of mood survey scale at 6 hours</measure>
    <time_frame>6 hours</time_frame>
    <description>Psychological response</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline blood pressure at 6 hours</measure>
    <time_frame>6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline lung function at 6 hours</measure>
    <time_frame>6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline respiratory gas analysis at 6 hours</measure>
    <time_frame>6 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Widely pristine area</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Outdoor mountain hiking (approximately 6 hours, 8km, 800 altitude meters, estimated speed: 4km/h [uphill], 5.2km/h [downhill]) in a widely pristine area with moderate intensity (Rating of perceived exertion: ~ 11-15).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anthropogenically influenced area</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Outdoor mountain hiking (approximately 6 hours, 8km, 800 altitude meters, estimated speed: 4km/h [uphill], 5.2km/h [downhill]) in an anthropogenically influenced area with moderate intensity (Rating of perceived exertion: ~ 11-15).&#xD;
All characteristics of the hiking (duration, time, difference in altitude, ...) are planned to be comparable to the experimental condition except the area.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mountain hiking</intervention_name>
    <description>Compare arm description</description>
    <arm_group_label>Anthropogenically influenced area</arm_group_label>
    <arm_group_label>Widely pristine area</arm_group_label>
    <other_name>Walking</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  voluntary participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  breastfeeding&#xD;
&#xD;
          -  chronic or acute diseases (already existing or diagnosed during the study)&#xD;
&#xD;
          -  unable to be physically active assessed by the Physical Activity Readiness&#xD;
             Questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Sport Science, Medical Section, University of Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>28520774</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaet Innsbruck</investigator_affiliation>
    <investigator_full_name>Martin Burtscher</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>affective responses</keyword>
  <keyword>stress-related parameters</keyword>
  <keyword>green exercise</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03229434
org study id: ARMH_2
nct id: NCT03229434
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In a randomized crossover design, approximately 50 healthy participants will be randomly
      exposed to outdoor mountain hiking (approximately 6 hours each) in two different areas: an
      anthropogenically influenced area and in a widely pristine area.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
masking description: pseudonymes
measure: Change from baseline Cortisol (Saliva Sampling) at 6 hours
time frame: 6 hours
description: Physiological response
measure: Change from baseline subscales of mood survey scale at 6 hours
time frame: 6 hours
description: Psychological response
measure: Change from baseline blood pressure at 6 hours
time frame: 6 hours
measure: Change from baseline lung function at 6 hours
time frame: 6 hours
measure: Change from baseline respiratory gas analysis at 6 hours
time frame: 6 hours
arm group label: Widely pristine area
arm group type: Experimental
description: Outdoor mountain hiking (approximately 6 hours, 8km, 800 altitude meters, estimated speed: 4km/h [uphill], 5.2km/h [downhill]) in a widely pristine area with moderate intensity (Rating of perceived exertion: ~ 11-15).
arm group label: Anthropogenically influenced area
arm group type: Active Comparator
description: Outdoor mountain hiking (approximately 6 hours, 8km, 800 altitude meters, estimated speed: 4km/h [uphill], 5.2km/h [downhill]) in an anthropogenically influenced area with moderate intensity (Rating of perceived exertion: ~ 11-15).
All characteristics of the hiking (duration, time, difference in altitude, ...) are planned to be comparable to the experimental condition except the area.
intervention type: Behavioral
intervention name: Mountain hiking
description: Compare arm description
arm group label: Anthropogenically influenced area
arm group label: Widely pristine area
other name: Walking
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Austria
citation: 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.
PMID: 28520774
responsible party type: Principal Investigator
investigator affiliation: Universitaet Innsbruck
investigator full name: Martin Burtscher
investigator title: Prof.