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

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

About this trial

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.

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

  • Descent from 2850m to sea level

    Behavioral

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

Treatment groups

14 Participants
are divided into 1 treatment group
Group A: Six-minute walking distance 6MWD at sea levelExperimental treatment 1 intervention

Trial outcomes

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

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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