Healthy, Healthy Adult, High Altitude, High Altitude Effects, Six-minute Walk Test
Conditions
Keywords
hypoxia, high altitude, six-minute walking distance, Health, NYHA, Exercise testing
Brief summary
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.
Detailed description
The aim of this research is to investigate the six-minute walking distance and other scores before and after re-ascent (sea level for 7 days vs. re-ascent to 2850m) in healthy individuals, who permanently live at high altitude over 2600m.
Interventions
BEHAVIORALRe-Ascent sea level to 2850m
After 7 days at sea level return/re-ascent to their usual living altitude at 2850m
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 after 7 days at sea level and after re-ascent to 2850m
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 re-ascent to 2850m | From Day 5-7 at sea level to the day after re-ascent | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 at rest and end-exercise after re-ascent to 2850m | From Day 5-7 at sea level to the day after re-ascent | 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 |
| Heart rate at rest and end-exercise after re-ascent to 2850m | From Day 5-7 at sea level to the day after re-ascent | 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 |
| Blood pressure at rest and end-exercise after re-ascent to 2850m | From Day 5-7 at sea level to the day after re-ascent | 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 |
| Dyspnea and leg discomfort sensation after re-ascent to 2850m | From Day 5-7 at sea level to the day after re-ascent | 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 |
| NYHA functional class after re-ascent to 2850m | From Day 5-7 at sea level to the day after re-ascent | Difference/change in NYHA functional class (New York Heart Association Class I-IV, IV being the worst) at rest and end-exercise between sea level (after one-week stay) and day after re-ascent to 2850m in healthy individuals |
| Quality of life after re-ascent to 2850m | From Day 5-7 at sea level to the day after re-ascent | 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 sea level (after one-week stay) and day after re-ascent to 2850m in healthy individuals |
| General well-being after re-ascent to 2850m | From Day 5-7 at sea level to the day after re-ascent | Difference/change in general well-being (Visual Analog Scale 10cm: the higher, the worse) between sea level (after one-week stay) and day after re-ascent to 2850m in healthy individuals |
| Six-minute walking test pre-descent to after re-ascent | Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days) | Difference/change in six-minute walking distance (6MWD) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals |
| SpO2 at rest and end-exercise pre-descent to after re-ascent | Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days) | Difference/change in SpO2 (peripheral oxygen saturation) at rest and end-exercise with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals |
| Heart rate at rest and end-exercise pre-descent to after re-ascent | Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days) | Difference/change in heart rate at rest and end-exercise with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals |
| Blood pressure at rest and end-exercise pre-descent to after re-ascent | Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days) | Difference/change in blood pressure at rest and end-exercise with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals |
| Dyspnea and leg discomfort pre-descent to after re-ascent | Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days) | 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 with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals |
| NYHA functional class pre-descent to after re-ascent | Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days) | Difference/change in NYHA functional class (New York Heart Association Class I-IV, IV being the worst) at 2850m with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals |
| Quality of life pre-descent to after re-ascent | Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days) | Difference/change in quality of life (EmPHasis-10: Score with 10 questions and 0-50 points, higher scores indicating poorer quality of life) with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) in healthy individuals |
| General well-being pre-descent to after re-ascent | Baseline at 2850m followed by a one-week stay at sea level to the day after re-ascent back to 2850m (time frame approximately 11 days) | Difference/change in general well-being (Visual Analog Scale 10cm: the higher, the worse) with a one-week stay at sea level in between (day pre-descent vs. day after re-ascent) 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