NCT07801872

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress10%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

August 17, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

September 25, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

9 days

First QC Date

August 17, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

six-minute walking distancehigh altitudehypoxiaNYHA

Outcome Measures

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

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

Secondary Outcomes (15)

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

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

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

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

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

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

  • Dyspnea and leg discomfort sensation after 7 days at sea level

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

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

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

  • +10 more secondary outcomes

Study Arms (1)

Six-minute walking distance 6MWD at sea level

EXPERIMENTAL

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

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

Six-minute walking distance 6MWD at sea level

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Altitude SicknessHypoxia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Silvia Ulrich

    University Hospital Zurich, Departement of Pulmonology

    PRINCIPAL INVESTIGATOR
  • Rodrigo Hoyos

    Hospital Carlos Andrade Marin of Quito, Ecuador

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Ulrich, Prof. Dr. med.

CONTACT

Michael Furian, Prof. Dr. sc. ETH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Healthy individuals living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m and after descent to sea level
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

August 17, 2026

First Posted

September 3, 2026

Study Start

September 25, 2026

Primary Completion

October 4, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Data will be provided upon request and based on a clear intention reviewed by an ethical review board.

Locations