Clinical trial NCT03335891: The Effects of Core Stabilization Training Among Patients With Asthma: A Randomized Controlled Trial
Official title: The Effects of Core Stabilization Training on Dynamic Balance and Pulmonary Parameters Among Patients With Asthma: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma education program
balance
core stabilization exercises
Lead sponsor: Yeditepe University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2017-11-08
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Maximum Inspiratory Pressure
timeFrame: Six Weeks
measure: Functional Capacity Test
timeFrame: Six Weeks
measure: Forced vital capacity in 1 second (FEV1)
timeFrame: Six Weeks
measure: Quality of life
timeFrame: Six Weeks
measure: Maximum Expiratory Pressure
timeFrame: Six Weeks
measure: Functional Vital Capacity (FVC)
timeFrame: Six Weeks
measure: Tiffeneau Ratio (FEV1/FVC)
timeFrame: Six Weeks
measure: Forced Expiratory Flow from 25 % to 75 % of Vital Capacity (FEF25-75)
timeFrame: Six Weeks
Secondary outcomes:
measure: Physical Activity
timeFrame: Six Weeks
measure: Depression level
timeFrame: Six Weeks
measure: Anxiety level
timeFrame: Six Weeks
measure: Dynamic balance
timeFrame: Six Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
name: Elif Develi, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeditepe University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
name: Feryal Subasi, Professor
role: STUDY_CHAIR
affiliation: Istanbul University, Health Sciences Faculty, Department of Physiotherapy and Rehabilitation
name: Göksen Kuran Aslan, PhD
role: STUDY_CHAIR
affiliation: Chest Medicine Outpatient Clinic of Istanbul University, Istanbul Medical Faculty
name: Zuleyha Kaya Bingol, MD, Associate Professor
role: STUDY_DIRECTOR
References: