Effect of High AltitudeNCT02741583
Kyrgyz Asthma Rehabilitation at High Altitude
A study testing altitude rehabilitation program and rehabilitation program in people with Effect of High Altitude, run by University of Zurich at 1 site in Switzerland.
Trial summary
prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and asthma control. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Effect of High Altitude
- What is being tested?
- altitude rehabilitation program and rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with atopic or non-atopic Asthma for at least 3 months
- partly controlled on regular or on demand inhaled therapy according to guidelines.
- asthma variability in peak expiratory flow > 10%/day and/or a reversible airflow obstruction in spirometry
- History of asthma consisting of variable symptoms (cough, dyspnea, wheezing).
Who cannot join
- Unstable and severely uncontrolled asthma needing systemic corticosteroids.
- Need of continuous oral steroids for their asthma control
- Heavy smokers (>20 cigarettes per day)
- Severe concomitant diseases preventing patients to adhere to the protocol and/or altitude exposure (severe metabolic, kidney- or liver disease, heart failure (ejection fracture <50%).
- Chronic lung diseases with a persistent FVC < 60% an/or arterial oxygen saturation <92%).
- Severe mental- or musculoskeletal disorders
- Pregnant or breast feeding women
- Patient which are unable to comply with the study procedure.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Respiratory Clinic, University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Asthma Rehabilitation at High vs. Low Altitude: Randomized Controlled Parallel-group Trial
prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and asthma control.
Read the detailed description
Low altitude baseline measurements will be performed in Bishkek. Participants will then either be assigned to a rehabilitation program in Bishkek (760m) or in Tuja Ashu (3200m).
The rehabilitation programs in high or low altitude will be identically performed and will comprise
- asthma education and awareness
- instruction on inhaled therapies
- smoking cessation counseling
- respiratory and skeletal muscle training in groups
- guided walks / cycle ergometer training
- questionnaires on asthma control, quality of life
- spirometry and peak flow measurements
- echocardiography
Measurement on study subjects will be performed at baseline (Bishkek), during the rehabilitation program, after completion of the rehabilitation program and during a follow-up at week 15.
- Conditions
- Effect of High Altitude
- Being tested
- altitude rehabilitation program, rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
altitude rehabilitation programOther
altitude exposure
rehabilitation programOther
Rehabilitation at low altitude
| Study group | Role | What they receive |
|---|---|---|
| altitude rehabilitation program | Experimental | 3 weeks rehabilitation program at high altitude (3200m) Receives: Other: altitude rehabilitation program |
| rehabilitation program | Active comparator | 3 weeks rehabilitation program at low altitude (760m) Receives: Other: rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily peak-flow variability
Measured: assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements
change in asthma control questionnaire score
Measured: baseline to week 3 and 15
Secondary outcomes (10)
forced expiratory volume in 1 second (FEV1)
Measured: baseline to week 3 and 15
average peak flow over 2 days
Measured: baseline to week 3 and 15
spirometric values (Forced vital capacity (FVC), FEV1/FVC)
Measured: from baseline to week 3 and 15
asthma-related quality of life (AQLQ)
Measured: from baseline to week 3 and 15
generic quality of life (Short-Form 36(SF-36))
Measured: from baseline to week 3 and 15
symptoms of acute mountain sickness (AMS) by the environmental symptom cerebral score (AMS-c)
Measured: from baseline to week 3 and 15
6 minute walk distance
Measured: from baseline to week 3 and 15
sit-to-stand test
Measured: from baseline to week 3 and 15
arterial oxygen saturation by pulse oximetry
Measured: from baseline to week 3 and 15
visual analog scale (VAS)
Measured: from baseline to week 3 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of High AltitudeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich Somaini, MD, Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741583
- Sponsor's protocol ID
- Req-2016-00076
- Status last verified
- Oct 2016
- First submitted
- 12 Apr 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Saxer S, Schneider SR, Appenzeller P, Bader PR, Lichtblau M, Furian M, Sheraliev U, Estebesova B, Emilov B, Sooronbaev T, Bloch KE, Ulrich S. Asthma rehabilitation at high vs. low altitude: randomized parallel-group trial. BMC Pulm Med. 2019 Jul 24;19(1):134. doi: 10.1186/s12890-019-0890-y.
PubMed 31340793
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Rehabilitation at High vs. Low Altitude: Randomized Controlled Parallel-group Trial
- ClinicalTrials.gov ID
- NCT02741583
- Acronym / sponsor ID
- Req-2016-00076
- Conditions
- Effect of High Altitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
prospective controlled interventional trial evaluating the efficacy of a 3-weeks asthma rehabilitation program at high altitude (3200m) and low altitude (760m) on lung function and asthma control.
Detailed description
Low altitude baseline measurements will be performed in Bishkek. Participants will then either be assigned to a rehabilitation program in Bishkek (760m) or in Tuja Ashu (3200m).
The rehabilitation programs in high or low altitude will be identically performed and will comprise
- asthma education and awareness
- instruction on inhaled therapies
- smoking cessation counseling
- respiratory and skeletal muscle training in groups
- guided walks / cycle ergometer training
- questionnaires on asthma control, quality of life
- spirometry and peak flow measurements
- echocardiography
Measurement on study subjects will be performed at baseline (Bishkek), during the rehabilitation program, after completion of the rehabilitation program and during a follow-up at week 15.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| altitude rehabilitation program | Experimental | Other: altitude rehabilitation program3 weeks rehabilitation program at high altitude (3200m) |
| rehabilitation program | Active comparator | Other: rehabilitation program3 weeks rehabilitation program at low altitude (760m) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with atopic or non-atopic Asthma for at least 3 months
- partly controlled on regular or on demand inhaled therapy according to guidelines.
- asthma variability in peak expiratory flow > 10%/day and/or a reversible airflow obstruction in spirometry
- History of asthma consisting of variable symptoms (cough, dyspnea, wheezing).
Key exclusion criteria (8 listed)
- Unstable and severely uncontrolled asthma needing systemic corticosteroids.
- Need of continuous oral steroids for their asthma control
- Heavy smokers (>20 cigarettes per day)
- Severe concomitant diseases preventing patients to adhere to the protocol and/or altitude exposure (severe metabolic, kidney- or liver disease, heart failure (ejection fracture <50%).
- Chronic lung diseases with a persistent FVC < 60% an/or arterial oxygen saturation <92%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| altitude rehabilitation programaltitude exposure | Other | altitude rehabilitation program |
| rehabilitation programRehabilitation at low altitude | Other | rehabilitation program |
Primary outcome
daily peak-flow variability
Time frame: assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements
change in asthma control questionnaire score
Time frame: baseline to week 3 and 15
10 secondary outcomes
forced expiratory volume in 1 second (FEV1)
Time frame: baseline to week 3 and 15
average peak flow over 2 days
Time frame: baseline to week 3 and 15
spirometric values (Forced vital capacity (FVC), FEV1/FVC)
Time frame: from baseline to week 3 and 15
asthma-related quality of life (AQLQ)
Time frame: from baseline to week 3 and 15
generic quality of life (Short-Form 36(SF-36))
Time frame: from baseline to week 3 and 15
symptoms of acute mountain sickness (AMS) by the environmental symptom cerebral score (AMS-c)
Time frame: from baseline to week 3 and 15
6 minute walk distance
Time frame: from baseline to week 3 and 15
sit-to-stand test
Time frame: from baseline to week 3 and 15
arterial oxygen saturation by pulse oximetry
Time frame: from baseline to week 3 and 15
visual analog scale (VAS)
Time frame: from baseline to week 3 and 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 31340793Saxer S, Schneider SR, Appenzeller P, Bader PR, Lichtblau M, Furian M, Sheraliev U, Estebesova B, Emilov B, Sooronbaev T, Bloch KE, Ulrich S. Asthma rehabilitation at high vs. low altitude: randomized parallel-group trial. BMC Pulm Med. 2019 Jul 24;19(1):134. doi: 10.1186/s12890-019-0890-y.
- Individual participant dataSharing planned: Undecided
Related trials for Effect of High Altitude
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
High Altitude, Healthy Adult
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals
High Altitude, Healthy
Not yet recruiting
Assessment of Six-minute Walking Distance 6MWD Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Ulrich Somaini, MD study chair
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing altitude rehabilitation program and rehabilitation program in people with Effect of High Altitude, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily peak-flow variability (time frame: assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02741583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.