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Kyrgyz Asthma Rehabilitation at High Altitude

NCT ID: NCT02741583

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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

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Effect of High Altitude

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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altitude rehabilitation program

3 weeks rehabilitation program at high altitude (3200m)

Group Type EXPERIMENTAL

altitude rehabilitation program

Intervention Type OTHER

altitude exposure

rehabilitation program

3 weeks rehabilitation program at low altitude (760m)

Group Type ACTIVE_COMPARATOR

rehabilitation program

Intervention Type OTHER

Rehabilitation at low altitude

Interventions

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altitude rehabilitation program

altitude exposure

Intervention Type OTHER

rehabilitation program

Rehabilitation at low altitude

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvia Ulrich Somaini, MD

Role: STUDY_CHAIR

University of Zurich

Locations

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Respiratory Clinic, University Hospital of Zurich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 31340793 (View on PubMed)

Other Identifiers

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Req-2016-00076

Identifier Type: -

Identifier Source: org_study_id