NCT03227341

Brief Summary

The investigators compared the effectiveness of pulmonary rehabilitation program on asthma control in patients with uncontrolled and partially controlled asthma.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

4 years

First QC Date

July 20, 2017

Last Update Submit

July 21, 2017

Conditions

Keywords

asthma controlpulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Asthma control test score

    A test measured the control of asthma

    4 weeks

Secondary Outcomes (6)

  • Exercise capacity

    6 minute

  • Dyspnea

    1 year

  • Quality of Life

    1 year

  • Pulmonary Function Test

    1 hour

  • Arterial Blood Gas

    1 hour

  • +1 more secondary outcomes

Study Arms (2)

patients with uncontrolled asthma.

OTHER

8 week pulmonary rehabilitation program

Other: Exercise

patients with partially controlled asthma

OTHER

8 week pulmonary rehabilitation program

Other: Exercise

Interventions

8 week exercise program including breathing exercises consisted of pursed-lip breathing, diaphragmatic breathing and thoracic expansion exercises, relaxation and stretching exercises, upper and lower extremity muscle strength training, and aerobic exercises. In addition, bronchial hygiene techniques and dyspnea-reducing positions

patients with partially controlled asthmapatients with uncontrolled asthma.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Asthmatic patients referred from the outpatient clinic to Pulmonary Rehabilitation unit was confirmed according to GINA guidelines

You may not qualify if:

  • If the initial diagnosis cannot be confirmed, the patient excluded from the study
  • Patients were under medical treatment of -6 months and considered clinically stable.
  • Patients with cardiovascular, other lung diseases (pneumoconiosis, pulmonary tuberculosis, interstitial lung disease), or musculoskeletal diseases that would impair exercise training were excluded from the study.
  • Also subjects with lack of motivation, poor compliance (not attending the program more than 2 times) or having transport problems were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Ilknur NAZ

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 24, 2017

Study Start

January 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 24, 2017

Record last verified: 2017-07