ClinicalTrials.gg
Not yet recruitingNCT07801872Updated Sep 3, 2026

Assessment of Six-minute Walking Distance 6MWD Between High Altitude HA vs. Sea Level LA in Healthy Individuals H

An interventional study of Descent from 2850m to sea level in High Altitude, Six-minute Walk Test and High Altitude Effects, sponsored by Silvia Ulrich Somaini. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Silvia Ulrich Somaini · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To study the effect of descent from high altitude (Quito Ecuador: 2850m) to sea level on six-minute walking distance and scores in healthy individuals, who live permanently >2600m.

Read the detailed description

The aim of this research is to investigate the six-minute walking distance and scores before and after descent (high altitude near their living altitude vs. sea level) in healthy individuals, who permanently live at high altitude over 2600m.

02

Conditions studied

  • High Altitude
  • Six-minute Walk Test
  • High Altitude Effects
  • Healthy
  • Healthy Adult

Keywords

  • six-minute walking distance
  • high altitude
  • hypoxia
  • NYHA
03

In context

Altitude Sickness

216 studies on the registry are indexed under Altitude Sickness; 46 are open to participants now.

This study's planned enrollment of 14 is below the median of 34 across 178 interventional studies indexed under Altitude Sickness.

Browse Altitude Sickness studies →

Lead sponsor

Silvia Ulrich Somaini is the lead sponsor of 17 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-80 years and of all genders
  • Permanent residence > 2600 m
  • healthy: no self-perceived cardiopulmonary disease limiting daily activities
  • written to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years or >80 years
  • Participants who cannot follow the study investigations
  • Participants permanently living \< 2600m
  • Participants who traveled and stayed overnight at altitudes \<2000 m in the past 4 weeks.
  • any self-perceived cardiopulmonary disease limiting daily activities
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    Six-minute walking distance 6MWD at sea level

    Assessment of the six-minute walking distance and scores near their resident altitude at 2850m followed by a descent from 2850m to sea level by bus with a stay for 7 days and again assessment of the same outcomes

    Behavioral: Descent from 2850m to sea level

Interventions

  • BehavioralDescent from 2850m to sea level

    Descent from 2850m to sea level with stay for 7 days

06

What researchers measure

Primary outcomes

  1. Six-minute walking distance after 7 days at sea level

    Difference/change in six-minute walking distance in meter (6MWD) between 2850m and Day 5-7 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 5-7 at sea level

Secondary outcomes

  1. SpO2 (%) at rest and end-exercise after 7 days at sea level

    Difference/change in SpO2 (peripheral oxygen saturation) at rest and end-exercise between 2850m and Day 5-7 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 5-7 at sea level

  2. Heart rate (beats per minute) at rest and end-exercise after 7 days at sea level

    Difference/change in heart rate at rest and end-exercise between 2850m and Day 5-7 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 5-7 at sea level

  3. Blood pressure (mmHg) at rest and end-exercise after 7 days at sea level

    Difference/change in blood pressure at rest and end-exercise between 2850m and Day 5-7 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 5-7 at sea level

  4. Dyspnea and leg discomfort sensation after 7 days at sea level

    Difference/change in dyspnea and leg discomfort sensation (assessed with BORG-CR10-Scale, Category Rating 0-10 with 10 being the most dyspnea/leg discomfort) at rest and end-exercise between 2850m and 5-7 days at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 5-7 at sea level

  5. NYHA functional class (1-4) after 7 days at sea level

    Difference/change in NYHA functional class (New York Heart Association Class I-IV, IV being the worst) at rest and end-exercise between 2850m and 5-7 days at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 5-7 at sea level

  6. Quality of life after 7 days at sea level

    Difference/change in quality of life score (EmPHasis-10: Score with 10 questions and 0-50 points, higher scores indicating poorer quality of life) between 2850m and 5-7 days at sea level in healthy individuals

    Time frame: From high altitude (2850m) to day 5-7 at sea level

  7. General well-being after 7 days at sea level

    Difference/change in general well-being (Visual Analog Scale 10cm: the higher, the worse) between 2850m and day 5-7 at sea level in healthy individuals

    Time frame: From high altitude (2850m) to Day 5-7 at sea level

  8. Acclimatization-effect of six-minute walking distance (m) at sea level

    Difference/change in six-minute walking distance (6MWD) within a stay at sea level of 7 days (after descent from 2850m) in healthy individuals

    Time frame: From Day 2 to Day 5-7 at sea level

  9. Acclimatization-Effect of SpO2 (%) at rest and end-exercise at sea level

    Difference/change in SpO2 (peripheral oxygen saturation) at rest and end-exercise within a stay at sea level of 7 days (after descent from 2850m) in healthy individuals

    Time frame: From Day 2 to Day 5-7 at sea level

  10. Acclimatization-Effect of heart rate (beats per minute) at rest and end-exercise at sea level

    Difference/change in heart rate at rest and end-exercise within a stay at sea level of 7 days (after descent from 2850m) in healthy individuals

    Time frame: From Day 2 to Day 5-7 at sea level

  11. Acclimatization-Effect of blood pressure (mmHg) at rest and end-exercise at sea level

    Difference/change in blood pressure at rest and end-exercise within a stay at sea level of 7 days (after descent from 2850m) in healthy individuals

    Time frame: From Day 2 to Day 5-7 at sea level

  12. Acclimatization-Effect of dyspnea and leg discomfort at sea level

    Difference/change in dyspnea and leg discomfort (assessed with BORG-CR10-Scale, Category Rating 0-10 with 10 being the most dyspnea/leg discomfort) at rest and end-exercise within a stay at sea level of 7 days (after descent from 2850m) in healthy individuals

    Time frame: From Day 2 to Day 5-7 at sea level

  13. Acclimatization-Effect of NYHA functional class (1-4) at sea level

    Difference/change in NYHA functional class (New York Heart Association Class I-IV, IV being the worst) at rest and end-exercise within a stay of 7 days at sea level (after descent from 2850m) in healthy individuals

    Time frame: From Day 2 to Day 5-7 at sea level

  14. Acclimatization-Effect of Quality of Life at sea level

    Difference/change in quality of life (EmPHasis-10: Score with 10 questions and 0-50 points, higher scores indicating poorer quality of life) within a stay of 7 days at sea level (after descent from 2850m) in healthy individuals

    Time frame: From Day 2 to Day 5-7 at sea level

  15. Acclimatization-Effect of general well-being at sea level

    Difference/change in general well-being (Visual Analog Scale 10cm: the higher, the worse) within a stay of 7 days at sea level (after descent from 2850m) in healthy individuals

    Time frame: From Day 2 to Day 5-7 at sea level

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07801872
Lead sponsor
Silvia Ulrich Somaini
Responsible party
Silvia Ulrich Somaini (Prof. Dr. med., University of Zurich) — Sponsor-investigator
First posted
Sep 3, 2026
Start date
Sep 25, 2026 (estimated)
Primary completion
Oct 4, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 3, 2026

Study contacts

Silvia Ulrich, Prof. Dr. med.
Contact
silvia.ulrich@usz.ch
+41442552220
Michael Furian, Prof. Dr. sc. ETH
Contact
+41442552220
Silvia Ulrich
principal investigator · University Hospital Zurich, Departement of Pulmonology
Rodrigo Hoyos
principal investigator · Hospital Carlos Andrade Marin of Quito, Ecuador

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion