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Kyrgyz Asthma Rehabilitation at High Altitude

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ClinicalTrials.gov Identifier: NCT02741583
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Information provided by (Responsible Party):
University of Zurich

Brief 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.

Condition or disease Intervention/treatment Phase
Effect of High Altitude Other: altitude rehabilitation program Other: rehabilitation program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Asthma Rehabilitation at High vs. Low Altitude: Randomized Controlled Parallel-group Trial
Study Start Date : May 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: altitude rehabilitation program
3 weeks rehabilitation program at high altitude (3200m)
Other: altitude rehabilitation program
altitude exposure

Active Comparator: rehabilitation program
3 weeks rehabilitation program at low altitude (760m)
Other: rehabilitation program
Rehabilitation at low altitude




Primary Outcome Measures :
  1. daily peak-flow variability [ Time Frame: assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements ]
  2. change in asthma control questionnaire score [ Time Frame: baseline to week 3 and 15 ]

Secondary Outcome Measures :
  1. forced expiratory volume in 1 second (FEV1) [ Time Frame: baseline to week 3 and 15 ]
  2. average peak flow over 2 days [ Time Frame: baseline to week 3 and 15 ]
  3. spirometric values (Forced vital capacity (FVC), FEV1/FVC) [ Time Frame: from baseline to week 3 and 15 ]
  4. asthma-related quality of life (AQLQ) [ Time Frame: from baseline to week 3 and 15 ]
  5. generic quality of life (Short-Form 36(SF-36)) [ Time Frame: from baseline to week 3 and 15 ]
  6. symptoms of acute mountain sickness (AMS) by the environmental symptom cerebral score (AMS-c) [ Time Frame: from baseline to week 3 and 15 ]
  7. 6 minute walk distance [ Time Frame: from baseline to week 3 and 15 ]
  8. sit-to-stand test [ Time Frame: from baseline to week 3 and 15 ]
  9. arterial oxygen saturation by pulse oximetry [ Time Frame: from baseline to week 3 and 15 ]
  10. visual analog scale (VAS) [ Time Frame: from baseline to week 3 and 15 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741583


Locations
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Switzerland
Respiratory Clinic, University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Investigators
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Study Chair: Silvia Ulrich Somaini, MD University of Zurich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02741583    
Other Study ID Numbers: Req-2016-00076
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Altitude Sickness
Respiration Disorders
Respiratory Tract Diseases