AsthmaNCT03335891
The Effects of Core Stabilization Training Among Patients With Asthma: A Randomized Controlled Trial
A study testing Core Stabilization Exercises in people with Asthma, run by Yeditepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Asthma
- What is being tested?
- Core Stabilization Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participating to the study in a voluntary basis.
- Being 18 years old and upper
- Getting diagnosed with asthma at least 6 months before.
Who cannot join
- Having an asthma attack in last 2 weeks.
- Having physical and/or mental disability.
- Having visual, hearing and/or verbal impairments.
About this study
Official title: The Effects of Core Stabilization Training on Dynamic Balance and Pulmonary Parameters Among Patients With Asthma: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
All volunteers received an asthma education program (AEP) and trained for diaphragmatic and pursed lip breathing exercises. Additionally, the TG participated in the core stabilization exercises program combined with AEP and breathing exercises. Data were collected from all the patients at baseline and post interventions (6 week) by the same physiotherapist who also supervised the exercise sessions.
All subjects were included in the asthma education program (AEP). AEP was performed at least once for approximately 20 minutes via face to face interviews. Education topics covered description of asthma, physiological changes of lungs, risk factors, treatment methods, relaxation positions to reduce dyspnea and usage of a specific inhaler. Breathing exercises were comprised of instructing breathing control, diaphragmatic breathing and pursed lip breathing exercises. Participants attended breathing exercises training for 2 days at the clinic under the supervision of a physiotherapist and 3 days at home as a home-exercise program. Total duration of breathing exercises lasted for 6 weeks. TG performed core stabilization exercises combined with breathing control for 2 days/a week for the duration of 6 weeks under the supervision of a physiotherapist at the clinic. Basic knowledges on spine, muscles of core stabilization and working principle of diaphragm and biofeedback unit (SPB) (Chattanooga Stabilizer Pressure Biofeedback, USA) were explained before the training. The SPB consists of an inflation pump and a cell like sphygmomanometer, which reflects body spinal movement in terms of mmHg by changing pressure in air filled cells. The SPB was placed under the lumbar 5th vertebra and patients attempted to maintain their core stability performing neutral zones at the settled level of 40 mmHg pressure. Furthermore, physiotherapist tried to improve thoracolumbar awareness by following changes from SPB and volunteers assured a constant lumbar position during upper and lower extremity movements combined with diaphragmatic movements. The 6 week exercise protocol emphasized core muscle co-contraction in hook-lying position with a flat cushion between two knees to provide integration between the pelvic floor muscles and diaphragm. Subsequently, exercises progressed as diaphragmatic breathing, flexion of both shoulder with breathing control and extending knees bilaterally with breathing control. Moreover, the hold time and the number of repetitions were increased from 5 repeats x 1 set to 5 repeats x 4 sets and each session lasted 20 minutes.
- Conditions
- Asthma
- Being tested
- Core Stabilization Exercises, Control
- Keywords
- asthma education program, balance, core stabilization exercises
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization ExercisesProcedure or surgery
Volunteers received an asthma education program and trained for diaphragmatic, pursed lip breathing exercises as well as participated in the core stabilization exercises program.
ControlProcedure or surgery
Volunteers received an asthma education program and trained for diaphragmatic andpursed lip breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Asthma Education Program Breathing Exercises Core Stabilization Exercises Receives: Procedure: Core Stabilization Exercises; Procedure: Control |
| Control Group | Active comparator | Asthma Education Program Breathing Exercises Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Inspiratory Pressure
The Micro Medical Micro RPM, England respiratory pressure meter was used to measure respiratory muscle strength
Measured: 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.
Measured: 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.
Measured: 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
Measured: Six Weeks
Maximum Expiratory Pressure
The Micro Medical Micro RPM, England respiratory pressure meter was used to measure respiratory muscle strength
Measured: Six Weeks
Functional Vital Capacity (FVC)
Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.
Measured: Six Weeks
Tiffeneau Ratio (FEV1/FVC)
Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.
Measured: 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.
Measured: Six Weeks
Secondary outcomes (4)
Physical Activity
International Physical Activity Questionnaire Short Form (IPAQ) was used to determine physical activity status.The total score of IPAQ is calculated by summation of the duration (in minutes) and frequency (days) of three physical activities.
Measured: Six Weeks
Depression level
The valid and reliable version of the Hospital Anxiety and Depression Scale (HADS) for the Turkish population was utilized to determine depression level.
Measured: Six Weeks
Anxiety level
The valid and reliable version of the Hospital Anxiety and Depression Scale (HADS) for the Turkish population was utilized to determine anxiety level.
Measured: Six Weeks
Dynamic balance
Dynamic balance alterations of the subjects were assessed by TechnoBody Prokin PK 200 (PK), Italy dynamic balance instrument. PK is a circular mobile balance assessment platform like conventional rocker board. PK transmits data from platform to the computer with a wireless transmitter and it can detect each single angular movement with a chip inside the platform. Additionally, PK has four different applicators (easy, medium, hard and rectangular) to place under the mobile platform. The bipedal position for 30 seconds with the easy applicator during the dynamic balance test was used. PK is connected to a computer; in this way each single movement is recorded by a computer in real time mode.
Measured: Six Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study startNov 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Elif Develi, Yeditepe University
- Investigators
- Elif Develi, M.Sc., Principal investigator, Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and RehabilitationFeryal Subasi, Professor, Study chair, Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and RehabilitationGöksen Kuran Aslan, PhD, Study chair, Istanbul University, Health Sciences Faculty, Department of Physiotherapy and RehabilitationZuleyha Kaya Bingol, MD, Associate Professor, Study director, Chest Medicine Outpatient Clinic of Istanbul University, Istanbul Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335891
- Sponsor's protocol ID
- Yeditepe University
- Status last verified
- Nov 2017
- First submitted
- 31 Oct 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Core Stabilization Training on Dynamic Balance and Pulmonary Parameters Among Patients With Asthma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03335891
- Acronym / sponsor ID
- Yeditepe University
- Conditions
- Asthma
- Keywords
- asthma education program, balance, core stabilization exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- Nov 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
All volunteers received an asthma education program (AEP) and trained for diaphragmatic and pursed lip breathing exercises. Additionally, the TG participated in the core stabilization exercises program combined with AEP and breathing exercises. Data were collected from all the patients at baseline and post interventions (6 week) by the same physiotherapist who also supervised the exercise sessions.
All subjects were included in the asthma education program (AEP). AEP was performed at least once for approximately 20 minutes via face to face interviews. Education topics covered description of asthma, physiological changes of lungs, risk factors, treatment methods, relaxation positions to reduce dyspnea and usage of a specific inhaler. Breathing exercises were comprised of instructing breathing control, diaphragmatic breathing and pursed lip breathing exercises. Participants attended breathing exercises training for 2 days at the clinic under the supervision of a physiotherapist and 3 days at home as a home-exercise program. Total duration of breathing exercises lasted for 6 weeks. TG performed core stabilization exercises combined with breathing control for 2 days/a week for the duration of 6 weeks under the supervision of a physiotherapist at the clinic. Basic knowledges on spine, muscles of core stabilization and working principle of diaphragm and biofeedback unit (SPB) (Chattanooga Stabilizer Pressure Biofeedback, USA) were explained before the training. The SPB consists of an inflation pump and a cell like sphygmomanometer, which reflects body spinal movement in terms of mmHg by changing pressure in air filled cells. The SPB was placed under the lumbar 5th vertebra and patients attempted to maintain their core stability performing neutral zones at the settled level of 40 mmHg pressure. Furthermore, physiotherapist tried to improve thoracolumbar awareness by following changes from SPB and volunteers assured a constant lumbar position during upper and lower extremity movements combined with diaphragmatic movements. The 6 week exercise protocol emphasized core muscle co-contraction in hook-lying position with a flat cushion between two knees to provide integration between the pelvic floor muscles and diaphragm. Subsequently, exercises progressed as diaphragmatic breathing, flexion of both shoulder with breathing control and extending knees bilaterally with breathing control. Moreover, the hold time and the number of repetitions were increased from 5 repeats x 1 set to 5 repeats x 4 sets and each session lasted 20 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Procedure: Core Stabilization Exercises, Procedure: ControlAsthma Education Program Breathing Exercises Core Stabilization Exercises |
| Control Group | Active comparator | Procedure: ControlAsthma Education Program Breathing Exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participating to the study in a voluntary basis.
- Being 18 years old and upper
- Getting diagnosed with asthma at least 6 months before.
Key exclusion criteria (3 listed)
- Having an asthma attack in last 2 weeks.
- Having physical and/or mental disability.
- Having visual, hearing and/or verbal impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Stabilization ExercisesVolunteers received an asthma education program and trained for diaphragmatic, pursed lip breathing exercises as well as participated in the core stabilization exercises program. | Procedure or surgery | Training Group |
| ControlVolunteers received an asthma education program and trained for diaphragmatic andpursed lip breathing exercises | Procedure or surgery | Control Group, Training Group |
Primary outcome
Maximum Inspiratory Pressure
Time frame: Six Weeks
The Micro Medical Micro RPM, England respiratory pressure meter was used to measure respiratory muscle strength
Functional Capacity Test
Time frame: Six Weeks
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.
Forced vital capacity in 1 second (FEV1)
Time frame: Six Weeks
Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.
Quality of life
Time frame: Six Weeks
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
Maximum Expiratory Pressure
Time frame: Six Weeks
The Micro Medical Micro RPM, England respiratory pressure meter was used to measure respiratory muscle strength
Functional Vital Capacity (FVC)
Time frame: Six Weeks
Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.
Tiffeneau Ratio (FEV1/FVC)
Time frame: Six Weeks
Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.
Forced Expiratory Flow from 25 % to 75 % of Vital Capacity (FEF25-75)
Time frame: Six Weeks
Medical International Research Spirodoc® Spiro, Italy brand named spirometry was used to evaluate pulmonary functions of volunteers.
4 secondary outcomes
Physical Activity
Time frame: Six Weeks
Depression level
Time frame: Six Weeks
Anxiety level
Time frame: Six Weeks
Dynamic balance
Time frame: Six Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Develi, M.Sc. principal investigator
Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
Feryal Subasi, Professor study chair
Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
Göksen Kuran Aslan, PhD study chair
Istanbul University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization Exercises in people with Asthma, run by Yeditepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Inspiratory Pressure (time frame: Six Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.