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NCT Number: NCT07801872

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

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.

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Key information

Conditions

High Altitude Altitude Sickness Healthy Healthy Adult High Altitude Effects Hypoxia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Six-minute Walk Test

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 informed consent to participate in the study

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

Treatment and study plan

Descent from 2850m to sea level

Behavioral

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

Primary outcomes

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

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

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

  6. Quality of life after 7 days at sea level

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

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

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

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

    Time frame: From Day 2 to Day 5-7 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

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

    Time frame: From Day 2 to Day 5-7 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

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

    Time frame: From Day 2 to Day 5-7 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

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

    Time frame: From Day 2 to Day 5-7 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

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

    Time frame: From Day 2 to Day 5-7 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

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

    Time frame: From Day 2 to Day 5-7 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

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

    Time frame: From Day 2 to Day 5-7 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

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

    Time frame: From Day 2 to Day 5-7 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

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Furian, Prof. Dr. sc. ETH

CONTACT

+41442552220

Silvia Ulrich, Prof. Dr. med.

CONTACT

[email protected]

+41442552220

Sponsors and collaborators

Lead sponsor

Silvia Ulrich Somaini

Other

Registry information

Official study title

Effect of a One-week Descent From 2850m to Sea Level and Re-ascent in Patients With Pulmonary Arterial Hypertension and Healthy Controls Permanently Living > 2600m on Pulmonary Hemodynamics, Exercise Capacity, Blood Oxygenation, Sleep Disordered Breathing and Further Outcomes

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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