Healthy, Healthy Adult, High Altitude, High Altitude Effects, Six-minute Walk Test
Conditions
Keywords
six-minute walking distance, high altitude, hypoxia, NYHA
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.
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.
Interventions
BEHAVIORALDescent from 2850m to sea level
Descent from 2850m to sea level with stay for 7 days
Sponsors
Silvia Ulrich Somaini
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Healthy individuals living permanently \> 2600m around Quito (Ecuador) will be assessed at 2850m and after descent to sea level
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute walking distance after 7 days at sea level | 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
| Measure | Time frame | Description |
|---|---|---|
| SpO2 (%) at rest and end-exercise after 7 days at sea level | 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 |
| 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 | Difference/change in heart rate at rest and end-exercise between 2850m and Day 5-7 at sea level in healthy individuals |
| 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 | Difference/change in blood pressure at rest and end-exercise between 2850m and Day 5-7 at sea level in healthy individuals |
| Dyspnea and leg discomfort sensation after 7 days at sea level | 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 |
| NYHA functional class (1-4) after 7 days at sea level | 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 |
| Quality of life after 7 days at sea level | 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 |
| General well-being after 7 days at sea level | 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 |
| Acclimatization-effect of six-minute walking distance (m) at sea level | 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 |
| Acclimatization-Effect of SpO2 (%) at rest and end-exercise at sea level | 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 |
| Acclimatization-Effect of heart rate (beats per minute) at rest and end-exercise at sea level | 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 |
| Acclimatization-Effect of blood pressure (mmHg) at rest and end-exercise at sea level | 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 |
| Acclimatization-Effect of dyspnea and leg discomfort at sea level | 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 |
| Acclimatization-Effect of NYHA functional class (1-4) at sea level | 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 |
| Acclimatization-Effect of Quality of Life at sea level | 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 |
| Acclimatization-Effect of general well-being at sea level | 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 |
Countries
Switzerland
Contacts
CONTACTSilvia Ulrich, Prof. Dr. med.
CONTACTMichael Furian, Prof. Dr. sc. ETH
PRINCIPAL_INVESTIGATORSilvia Ulrich
University Hospital Zurich, Departement of Pulmonology
PRINCIPAL_INVESTIGATORRodrigo Hoyos
Hospital Carlos Andrade Marin of Quito, Ecuador
Outcome results
None listed