NCT03229434

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 29, 2017

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

3 days

First QC Date

July 19, 2017

Last Update Submit

January 17, 2019

Conditions

Keywords

affective responsesstress-related parametersgreen exercise

Outcome Measures

Primary Outcomes (2)

  • Change from baseline Cortisol (Saliva Sampling) at 6 hours

    Physiological response

    6 hours

  • Change from baseline subscales of mood survey scale at 6 hours

    Psychological response

    6 hours

Secondary Outcomes (3)

  • Change from baseline blood pressure at 6 hours

    6 hours

  • Change from baseline lung function at 6 hours

    6 hours

  • Change from baseline respiratory gas analysis at 6 hours

    6 hours

Study Arms (2)

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).

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.

Behavioral: Mountain hiking

Interventions

Mountain hikingBEHAVIORAL

Compare arm description

Also known as: Walking
Anthropogenically influenced areaWidely pristine area

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • voluntary participation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sport Science, Medical Section, University of Innsbruck

Innsbruck, 6020, Austria

Location

Related Publications (1)

  • 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: 28520774BACKGROUND

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
pseudonymes
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 25, 2017

Study Start

October 29, 2017

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations