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Completed

NCT Number: NCT02741583

Kyrgyz Asthma Rehabilitation at High Altitude

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory Clinic, University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

altitude rehabilitation program

Other

altitude exposure

Rehabilitation program

Other

Rehabilitation at low altitude

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Registry information

Official study title

Asthma Rehabilitation at High vs. Low Altitude: Randomized Controlled Parallel-group Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 18, 2016
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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