Healthy ParticipantsNCT03229434
Mountain Hiking & Environmental Influences
A study testing Mountain hiking in people with Healthy Participants, run by Universitaet Innsbruck at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Mountain hiking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 29 Oct 2017to 1 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- voluntary participation
Who cannot join
- pregnancy
- breastfeeding
- chronic or acute diseases (already existing or diagnosed during the study)
- unable to be physically active assessed by the Physical Activity Readiness Questionnaire
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Sport Science, Medical Section, University of Innsbruck
Innsbruck, 6020
About this study
Official title: Effects of Mountain Hiking on Physiological and Psychological Health Parameters With Special Focus on the Influence of the Environment
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.
- Conditions
- Healthy Participants
- Being tested
- Mountain hiking
- Keywords
- affective responses, stress-related parameters, green exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mountain hikingBehavioural
Also called Walking
Compare arm description
| Study group | Role | What they receive |
|---|---|---|
| Widely pristine area | Experimental | 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). Receives: Behavioral: Mountain hiking |
| Anthropogenically influenced area | Active comparator | 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. Receives: Behavioral: Mountain hiking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Cortisol (Saliva Sampling) at 6 hours
Physiological response
Measured: 6 hours
Change from baseline subscales of mood survey scale at 6 hours
Psychological response
Measured: 6 hours
Secondary outcomes (3)
Change from baseline blood pressure at 6 hours
Measured: 6 hours
Change from baseline lung function at 6 hours
Measured: 6 hours
Change from baseline respiratory gas analysis at 6 hours
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start29 Oct 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaet Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Paracelsus Medical University
- Responsible party
- Principal investigator, Martin Burtscher, Universitaet Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229434
- Sponsor's protocol ID
- ARMH_2
- Status last verified
- Jan 2019
- First submitted
- 19 Jul 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28520774
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mountain Hiking on Physiological and Psychological Health Parameters With Special Focus on the Influence of the Environment
- ClinicalTrials.gov ID
- NCT03229434
- Acronym / sponsor ID
- ARMH_2
- Conditions
- Healthy Participants
- Keywords
- affective responses, stress-related parameters, green exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitaet InnsbruckUniversity, hospital or other
- Collaborators
- Paracelsus Medical University
- Study start
- 29 Oct 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Widely pristine area | Experimental | Behavioral: Mountain hikingOutdoor 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). |
| Anthropogenically influenced area | Active comparator | Behavioral: Mountain hikingOutdoor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- voluntary participation
Key exclusion criteria (4 listed)
- pregnancy
- breastfeeding
- chronic or acute diseases (already existing or diagnosed during the study)
- unable to be physically active assessed by the Physical Activity Readiness Questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mountain hikingAlso: WalkingCompare arm description | Behavioural | Anthropogenically influenced area, Widely pristine area |
Primary outcome
Change from baseline Cortisol (Saliva Sampling) at 6 hours
Time frame: 6 hours
Physiological response
Change from baseline subscales of mood survey scale at 6 hours
Time frame: 6 hours
Psychological response
3 secondary outcomes
Change from baseline blood pressure at 6 hours
Time frame: 6 hours
Change from baseline lung function at 6 hours
Time frame: 6 hours
Change from baseline respiratory gas analysis at 6 hours
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Background: PubMed 28520774Niedermeier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mountain hiking in people with Healthy Participants, run by Universitaet Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Cortisol (Saliva Sampling) at 6 hours (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03229434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019; AzTrials last refreshed its copy on 2 Nov 2026.