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Pulmonary Rehabilitation in Asthma Control

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring asthma control, pulmonary rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    patients with uncontrolled asthma.

    patients with partially controlled asthma

    Arm Description

    8 week pulmonary rehabilitation program

    8 week pulmonary rehabilitation program

    Outcomes

    Primary Outcome Measures

    Asthma control test score
    A test measured the control of asthma

    Secondary Outcome Measures

    Exercise capacity
    Six minute walk test
    Dyspnea
    MMRC Dyspnea Scale
    Quality of Life
    St. George Respiratory Questionnaire
    Pulmonary Function Test
    FEV1, FVC, DLCO
    Arterial Blood Gas
    PaO2, PaCO2, SaO2
    Anxiety and Depression
    Hospital Anxiety and Depression Scale

    Full Information

    First Posted
    July 20, 2017
    Last Updated
    July 21, 2017
    Sponsor
    Izmir Katip Celebi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03227341
    Brief Title
    Pulmonary Rehabilitation in Asthma Control
    Official Title
    Does Pulmonary Rehabilitation Contribute to Asthma Control?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2013 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    January 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Katip Celebi University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators compared the effectiveness of pulmonary rehabilitation program on asthma control in patients with uncontrolled and partially controlled asthma.
    Detailed Description
    Asthma treatment is not only medical, it also requires a comprehensive care including nonpharmacological treatment. Pulmonary rehabilitation represents the most important part of the comprehensive care. The investigators aimed to evaluate the efficacy of pulmonary rehabilitation in patients with uncontrolled and partially controlled asthma. Asthma patients referred to pulmonary rehabilitation (PR) unit were classified according to asthma control test; as partially controlled patients (Group 1), and as uncontrolled patients (Group 2). All patients received of a 8 week pulmonary rehabilitation program. Asthma control tests, pulmonary function tests, arterial blood gases analysis, dyspnea perception, quality of life, exercise capacity, anxiety and depression assessments were performed before and after pulmonary rehabilitation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    asthma control, pulmonary rehabilitation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with uncontrolled asthma.
    Arm Type
    Other
    Arm Description
    8 week pulmonary rehabilitation program
    Arm Title
    patients with partially controlled asthma
    Arm Type
    Other
    Arm Description
    8 week pulmonary rehabilitation program
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Asthma control test score
    Description
    A test measured the control of asthma
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Exercise capacity
    Description
    Six minute walk test
    Time Frame
    6 minute
    Title
    Dyspnea
    Description
    MMRC Dyspnea Scale
    Time Frame
    1 year
    Title
    Quality of Life
    Description
    St. George Respiratory Questionnaire
    Time Frame
    1 year
    Title
    Pulmonary Function Test
    Description
    FEV1, FVC, DLCO
    Time Frame
    1 hour
    Title
    Arterial Blood Gas
    Description
    PaO2, PaCO2, SaO2
    Time Frame
    1 hour
    Title
    Anxiety and Depression
    Description
    Hospital Anxiety and Depression Scale
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Asthmatic patients referred from the outpatient clinic to Pulmonary Rehabilitation unit was confirmed according to GINA guidelines Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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