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Kyrgyz Asthma Rehabilitation at High Altitude

Primary Purpose

Effect of High Altitude

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

altitude rehabilitation program

rehabilitation program

About this trial

This is an interventional prevention trial for Effect of High Altitude

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Respiratory Clinic, University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

altitude rehabilitation program

rehabilitation program

Arm Description

3 weeks rehabilitation program at high altitude (3200m)

3 weeks rehabilitation program at low altitude (760m)

Outcomes

Primary Outcome Measures

daily peak-flow variability

change in asthma control questionnaire score

Secondary Outcome Measures

forced expiratory volume in 1 second (FEV1)

average peak flow over 2 days

spirometric values (Forced vital capacity (FVC), FEV1/FVC)

asthma-related quality of life (AQLQ)

generic quality of life (Short-Form 36(SF-36))

symptoms of acute mountain sickness (AMS) by the environmental symptom cerebral score (AMS-c)

6 minute walk distance

sit-to-stand test

arterial oxygen saturation by pulse oximetry

visual analog scale (VAS)

Full Information

NCT ID

NCT02741583

First Posted

April 12, 2016

Last Updated

October 25, 2016

Sponsor

University of Zurich

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02741583

Brief Title

Kyrgyz Asthma Rehabilitation at High Altitude

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Effect of High Altitude

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

altitude rehabilitation program

Arm Type

Experimental

Arm Description

3 weeks rehabilitation program at high altitude (3200m)

Arm Title

rehabilitation program

Arm Type

Active Comparator

Arm Description

3 weeks rehabilitation program at low altitude (760m)

Intervention Type

Other

Intervention Name(s)

altitude rehabilitation program

Intervention Description

altitude exposure

Intervention Type

Other

Intervention Name(s)

rehabilitation program

Intervention Description

Rehabilitation at low altitude

Primary Outcome Measure Information:

Title

daily peak-flow variability

Time Frame

assessed at baseline, at run time of the rehabilitation program and 15 weeks after baseline measurements

Title

change in asthma control questionnaire score

Time Frame

baseline to week 3 and 15

Secondary Outcome Measure Information:

Title

forced expiratory volume in 1 second (FEV1)

Time Frame

baseline to week 3 and 15

Title

average peak flow over 2 days

Time Frame

baseline to week 3 and 15

Title

spirometric values (Forced vital capacity (FVC), FEV1/FVC)

Time Frame