NCT03335891

Brief Summary

Objective: To investigate the effectiveness of core stabilization exercises combined with the patient education program (AEP) and breathing exercises in patients with asthma. Design: A randomized controlled study Setting: Chest diseases clinic of a university hospital. Subjects: The study sample consists of 26-68 years old asthma patients who were diagnosed at least 6 month prior to the study. Interventions: All subjects were included in the asthma education program (AEP) and both groups were trained for diaphragmatic and pursed lip breathing exercises (2times/wk. 6-week duration at clinic). The core stabilization program was applied twice a week for a duration of 6 weeks in TG. Main Measures: Spirometry, maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP), International Physical Activity Questionnaire Short Form (IPAQ), Hospital Anxiety and Depression Scale(HADS), Asthma Quality of Life Questionnaire(AQOL), Six-minute walking test(6MWT), Prokin PK200, Italy were used to evaluate feasibility of interventions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Nov 2015

Shorter than P25 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

November 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

October 31, 2017

Last Update Submit

November 3, 2017

Conditions

Keywords

asthma education programbalancecore stabilization exercises

Outcome Measures

Primary Outcomes (8)

  • Maximum Inspiratory Pressure

    The Micro Medical Micro RPM, England respiratory pressure meter was used to measure respiratory muscle strength

    Six Weeks

  • Functional Capacity Test

    The Six Minute Walking Test was used to evaluate functional capacity of volunteers. 6MWT was performed on a 30 meter corridor in the clinic according to American Thoracic Society guidelines. Walking distance was calculated.

    Six Weeks

  • Forced vital capacity in 1 second (FEV1)

    Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.

    Six Weeks

  • Quality of life

    Asthma Quality of Life Scale (AQOL) was utilized to assess quality of life of participants over two weeks prior to the interview which was validated for the Turkish population.l

    Six Weeks

  • Maximum Expiratory Pressure

    The Micro Medical Micro RPM, England respiratory pressure meter was used to measure respiratory muscle strength

    Six Weeks

  • Functional Vital Capacity (FVC)

    Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.

    Six Weeks

  • Tiffeneau Ratio (FEV1/FVC)

    Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.

    Six Weeks

  • Forced Expiratory Flow from 25 % to 75 % of Vital Capacity (FEF25-75)

    Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.

    Six Weeks

Secondary Outcomes (4)

  • Physical Activity

    Six Weeks

  • Depression level

    Six Weeks

  • Anxiety level

    Six Weeks

  • Dynamic balance

    Six Weeks

Study Arms (2)

Training Group

EXPERIMENTAL

Asthma Education Program Breathing Exercises Core Stabilization Exercises

Procedure: Core Stabilization ExercisesProcedure: Control

Control Group

ACTIVE COMPARATOR

Asthma Education Program Breathing Exercises

Procedure: Control

Interventions

Volunteers received an asthma education program and trained for diaphragmatic, pursed lip breathing exercises as well as participated in the core stabilization exercises program.

Training Group
ControlPROCEDURE

Volunteers received an asthma education program and trained for diaphragmatic andpursed lip breathing exercises

Control GroupTraining Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participating to the study in a voluntary basis.
  • Being 18 years old and upper
  • Getting diagnosed with asthma at least 6 months before.

You may not qualify if:

  • Having an asthma attack in last 2 weeks.
  • Having physical and/or mental disability.
  • Having visual, hearing and/or verbal impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Elif Develi, M.Sc.

    Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR
  • Feryal Subasi, Professor

    Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation

    STUDY CHAIR
  • Göksen Kuran Aslan, PhD

    Istanbul University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation

    STUDY CHAIR
  • Zuleyha Kaya Bingol, MD, Associate Professor

    Chest Medicine Outpatient Clinic of Istanbul University, Istanbul Medical Faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 8, 2017

Study Start

November 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

November 8, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share