Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
Phase: NA
Conditions: Cystic Fibrosis
Sponsor: Marmara University

01.24.2017 
 
THE CLINICAL EFFECTS OF EXERCISE PROGRAM ADDED 
TO PULMONARY REHABILITATION PROGRAM IN PATIENTS 
WITH CYSTIC FIBROSIS  
NCT Number: 03295201 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

This study was planned to be a prospective single-blinded randomized controlled 
study and was performed between March 2017 and October 2017. Local ethics 
committee approval was taken (Marmara University, Istanbul, Turkey). Informed 
consents were obtained from the families of children. The inclusion and exclusion 
criteria were determined as shown below: 
 
Inclusion Criteria 
1. Patients diagnosed with cystic fibrosis (CF) 
2. Patients aged between 6-14 
3. FEV1 greater than 30% 
 
Exclusion Criteria 
1. Presence of cor pulmonale 
2. Spinal fracture story 
3. Currently under IV medication 
4. Severe gastroesophageal reflux 
 
 
The patients were equally randomized into two groups according to the 
closed envelope system. One group planned to treat six weeks with pulmonary 
rehabilitation and postural exercise program (Group 1), while other group being 
treated with pulmonary rehabilitation program alone (Group 2). Patients were 
assessed for respiratory function with FEV1, pain level with Visual Analog Scale 
(VAS), quality of life with The Cystic Fibrosis Questionnaire-Revised Child Version 
(CFQR), exercise tolerance with Modified Shuttle Test (MST) and postural stability 
with Neurocom Balance Master® Device Limits of Stability Test (LOS). All tests 
were performed before treatment and six weeks, three months and six months after 
treatment. Cobb and Modifiye Cobb angles were measured on radiographic 
examinations to evaluate spinal deformities before and six months after treatment. 
 
 
Treatment: 
 
Pulmonary Rehabilitation 
 
Active cycle of breathing techniques (ACBT)  
was preferred for pulmonary 
rehabilitation. ACBT was applied by a therapist once per a week for six weeks. A 
daily schedule was given for the other days of the week to ensure permanence of 
treatment. ACBT is a commonly used chest physiotherapy method for secretion 
removal from lungs.  Each ACBT cycle consists a sequence of breathing control, 
thoracic expansion exercises and forced expiration technique. These cycles are 
performed consecutively until the secretion is completely discharged. 
Postural exercise Program 
Thoracic vertebra mobilization, pectoral stretching, scapula and thoracic extensors 
strengthening and core stability exercises were applied by a therapist once per a week 
for six weeks. A daily schedule was given for the other days of the week to ensure 
permanence of treatment. 
 

Assessment: 
 
The Cystic Fibrosis Questionnaire-Revised (CFQR) 
 
The Cystic Fibrosis Questionnaire-Revised is the most commonly used quality of life 
measurement tool in patients with CF and is found to be valid and reliable in Turkish. 
The child version of this test consists 35 questions about physical function, emotional 
function, social function, body appearance, eating disorders, treatment difficulties, 
respiratory and digestive symptoms. Total score is calculated between 0-100 and 
higher scores define better condition. 
 
Modified Shuttle Test (MST) 
 
The Modified Shuttle Test is an easy test that can show exercise tolerance and 
cardiorespiratory status in children with CF. The patient is asked to walk until feeling 
tired between two fixed objects with a 10-meter interval, starting at normal walking 
speed and increasing the speed at the beginning of each minute. Maximum distance is 
measured for the test. 
 
Limits of Stability Test (LOS) 
 
The Limits of Stability Test consists a 18x60 inch of a pressure platform which 
connected to a computer system. The patient is asked to stand on the platform 
barefoot and watch the image which can be moved by trunk movement on the 
computer the monitor. It is required to move the image towards to target points on 
monitor with commands. Reaction time, movement velocity, endpoint excursion, 
maximum excursion and direction control parameters are calculated during these 
trunk movements. 
 
Radiographic evaluation 
 
The Cobb angle was measured on antero-posterior scoliosis graphs by the angle 
between the superior end plate of the vertebra corpus where the curve begins and the 
end plate of the vertebra corpus which the curve ends. The Modified Cobb angle was 
found on lateral scoliosis graphs by the angle between the superior end plate of the T4 
vertebra corpus and the inferior end plate of the T12 vertebra corpus. 
 
 
 
 
 
 
 
 
 
 
 

Statistical analysis 
 
Statistical analysis of the study was calculated using the SPSS for Windows 20.0 
program. Normal distribution of quantitative values was assessed by histogram, Q-Q 
graph and normality tests. The Mann-Whitney U test was used to compare the 
measurement values between the two groups, and the Friedman test was used to 
compare the intra-group parameters. A statistical significance level of p <0,05 was 
accepted. The Wilcoxon test was used to compare pre-treatment and post-treatment 
6th-week, 3rd-month and 6th-month values separately. Bonferroni correction was 
considered p <0,017 statistically significant for evaluating the results. A Spearman 
and Pearson correlation analysis was performed to examine the relationship between 
the radiographic values measured by two different clinicians. The intraclass 
correlation coefficient for the interobserver reliability analysis was calculated for 
radiographic measurements.