AffectNCT02853760

Affective Responses in Mountain Hiking

A study testing walking and Treadmill in people with Affect, run by Universitaet Innsbruck.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Affect
What is being tested?: walking and Treadmill
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: No sites listed yet
Study dates: May 2015to Oct 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

voluntary participation

Who cannot join

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)

About this study

Official title: Affective Responses in Mountain Hiking: A Randomized Controlled Trial Focusing on Differences Between Indoor and Outdoor Activity

Conditions: Affect
Being tested: walking, Treadmill

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

walkingBehavioural
TreadmillDevice

Study groups in NCT02853760
Study group	Role	What they receive
Outdoor mountain hiking (M)	Experimental	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). Receives: Behavioral: walking
Indoor treadmill walking (T)	Active comparator	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). Receives: Behavioral: walking; Device: Treadmill
Sedentary control condition (C)	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline and 3 hours
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.
Measured: baseline and 3 hours after baseline
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.
Measured: baseline and 3 hours after baseline

Secondary outcomes (3)

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.
Measured: baseline and 3 hours
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.
Measured: baseline and 3 hours
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.
Measured: baseline and 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Oct 2015

First posted3 Aug 2016 (estimated)
Study startMay 2015
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AffectStudies 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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02853760
Sponsor's protocol ID: ARMH
Status last verified: May 2022
First submitted: 27 Jul 2016
Last updated: 18 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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
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.
PubMed 28800067

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Affective Responses in Mountain Hiking: A Randomized Controlled Trial Focusing on Differences Between Indoor and Outdoor Activity
ClinicalTrials.gov ID: NCT02853760
Acronym / sponsor ID: ARMH
Conditions: Affect
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Universitaet InnsbruckUniversity, hospital or other
Collaborators: Paracelsus Medical University
Study start: May 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 3 Aug 2016 (estimated)
Results: Posted 25 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Outdoor mountain hiking (M)	Experimental	Behavioral: walkingFirst 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).
Indoor treadmill walking (T)	Active comparator	Behavioral: walking, Device: TreadmillTo 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).
Sedentary control condition (C)	No intervention	–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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

voluntary participation

Key exclusion criteria (5 listed)

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)

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
walking	Behavioural	Indoor treadmill walking (T), Outdoor mountain hiking (M)
Treadmill	Device	Indoor treadmill walking (T)

Primary outcome

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.
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.
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.

3 secondary outcomes

Change From Baseline Blood Pressure at 3 Hours
Time frame: baseline and 3 hours
Change From Baseline Heart Rate Variability at 3 Hours
Time frame: baseline and 3 hours
Change From Baseline Cortisol at 3 Hours (Saliva Sampling)
Time frame: baseline and 3 hours

Results and safety

Results posted to the registry on 25 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence Group MTC	7	7
Sequence Group MCT	10	10
Sequence Group TMC	7	7
Sequence Group TCM	8	8
Sequence Group CTM	8	8
Sequence Group CMT	7	7

Primary outcome: Change From Baseline Subscales of Mood Survey Scale at 3 Hours

Time frame: baseline and 3 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Outdoor Mountain Hiking (M) n = 42	Indoor Treadmill Walking (T) n = 42	Sedentary Control Condition (C) n = 42
Value	0.54 (3.73)	-1.27 (3.79)	-2.22 (3.84)

Primary outcome: Change From Baseline Feeling Scale at 3 Hours

Time frame: baseline and 3 hours after baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Outdoor Mountain Hiking (M) n = 42	Indoor Treadmill Walking (T) n = 42	Sedentary Control Condition (C) n = 42
Value	1.37 (1.66)	0.36 (2.07)	-0.81 (1.77)

Primary outcome: Change From Baseline Felt Arousal Scale at 3 Hours

Time frame: baseline and 3 hours after baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Outdoor Mountain Hiking (M) n = 42	Indoor Treadmill Walking (T) n = 42	Sedentary Control Condition (C) n = 42
Value	0.15 (1.45)	-0.19 (1.50)	-0.57 (1.06)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the 3 interventions and the measurements, approximately 3.5 hours each. During the 2 washout phases, approximately 1 week each, by self-report of the participants.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Outdoor Mountain Hiking (M)	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Indoor Treadmill Walking (T)	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Sedentary Control Condition (C)	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Limitations and caveats (from the sponsor): * not feasible to apply downhill walking in the indoor situation, which resulted in a slightly different form of physical activity during the second part of the intervention * affective responses might be influenced by at least two confounding variables: the level of social interaction and the intensity of PA. * we did not include a follow-up measurement * we are aware about a possible selection bias in the present study * the length of the washout phase was not the same in all subjects

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: 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.
Results publication: PubMed 28800067Niedermeier 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.

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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.

Martin Kopp, Prof. study director

martin.kopp@uibk.ac.at

Questions about this trial

What is this clinical trial studying?

A study testing walking and Treadmill in people with Affect, run by Universitaet Innsbruck.

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 5 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 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 25 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Subscales of Mood Survey Scale at 3 Hours (time frame: baseline and 3 hours). The study lists 3 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 NCT02853760, which also lists 2 linked publications.

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 18 May 2022.