Assessment of Six-minute Walking Distance Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSilvia Ulrich Somaini

About this trial

To study the effect of a re-ascent after a one-week stay at sea level (after prior descent from 2850m) to high altitude (Quito Ecuador: 2850m) on six-minute walking distance and other scores in healthy individuals, who live permanently \>2600m.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Re-Ascent sea level to 2850m

    Behavioral

    After 7 days at sea level return/re-ascent to their usual living altitude at 2850m

Treatment groups

14 Participants
are divided into 1 treatment group
Group A: SIx-minute walking distance 6MWD after re-ascent at 2850mExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Six-minute walking distance after re-ascent to 2850m

Difference/change in six-minute walking distance 6MWD between sea level (after one-week stay) and day after re-ascent at 2850m in healthy individuals

Time frame
From Day 5-7 at sea level to the day after re-ascent

Secondary outcomes

1

SpO2 at rest and end-exercise after re-ascent to 2850m

Difference/change in SpO2 (peripheral oxygen saturation) at rest and end-exercise between sea level (after one-week stay) and Day after re-ascent to 2850m in healthy individuals

Time frame
From Day 5-7 at sea level to the day after re-ascent
2

Heart rate at rest and end-exercise after re-ascent to 2850m

Difference/change in heart rate at rest and end-exercise between sea level (after one-week stay) and Day after re-ascent to 2850m in healthy individuals

Time frame
From Day 5-7 at sea level to the day after re-ascent
3

Blood pressure at rest and end-exercise after re-ascent to 2850m

Difference/change in blood pressure at rest and end-exercise between sea level (after one-week stay) and Day after re-ascent to 2850m in healthy individuals

Time frame
From Day 5-7 at sea level to the day after re-ascent
4

Dyspnea and leg discomfort sensation after re-ascent to 2850m

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 sea level (after one-week stay) and day after re-ascent to 2850m in healthy individuals

Time frame
From Day 5-7 at sea level to the day after re-ascent

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Silvia Ulrich Somaini

Lead sponsor

University of Zurich

Sponsor institution

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