Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05470192 |
| Other study ID # |
AU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 28, 2022 |
| Est. completion date |
November 1, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Akdeniz University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Postoperative pulmonary complications after thoracotomy cause morbidity and mortality.
Although the causes of postoperative pulmonary complication are multifactorial, respiratory
muscle dysfunction is a contributing factor to the development of postoperative pulmonary
complication. This phenomenon has been explained by changes in respiratory muscle mechanics
and operative function. Exercise interventions following lung resection have been shown to be
associated with benefits on functional capacity, quality of life, shoulder pain, and shoulder
function. Following thoracotomy, postoperative pulmonary complications are a significant
cause of morbidity and cause significant increase in health care costs, intensive care and
hospital stay, and patient discomfort. Conventional physiotherapy and rehabilitation program
applied after thoracotomy reduces hospital stay and incidence of atelectasis.
Thoracotomy may also result in long-term limitation of shoulder function and range of motion,
reduced muscle strength, chronic pain, and reduced health-related quality of life.
Physiotherapy program; It provides some benefits such as reduction of pain, improvement of
shoulder function and physical components of quality of life. Based on these findings; It is
recommended that physiotherapists provide a postoperative exercise program aimed at reducing
shoulder dysfunction and pain, including progressive shoulder and rib cage exercises and a
home program after discharge.
In recent years, the popularity of Tai Chi, Qigong and yoga, also known as body-mind
exercises in the treatment of chronic diseases, has increased.
Description:
A standard posterolateral thoracotomy incision is usually performed in lung surgery due to
its various advantages. Standard posterolateral thoracotomy is also used in lung problems
such as lung parenchyma problems, hydatid cyst, mesothelioma, bullous disease of the lung
along with cancer. In a standard posterolateral thoracotomy, the latissimus dorsi and
serratus anterior muscles are cut. Latissimus dorsi muscle; Although it is very effective in
deep inspiration, strong cough, shoulder girdle activity, it is also the accessory muscle of
expiration. When the past 90 years are examined, standard posterolateral thoracotomy; It has
been found that there are some disadvantages such as postoperative pulmonary complications
due to cutting large muscle groups, increased potential blood loss, restricted shoulder and
upper extremity joint range of motion, prolonged dysfunction, scoliosis formation, severe and
chronic postoperative pain and cosmetic problems. These; Cutting large muscle groups,
damaging the shoulder girdle muscles, restricting shoulder and upper extremity joint
movements, causing postoperative pulmonary failure, pain and morbidity. The standard
posterolateral thoracotomy is the most commonly used incision in non-cardiac open thoracic
surgical procedures. The fact that it can be applied in all thoracic pathologies makes it the
most used incision. Allowing the operating surgeon and assistant to use their hands together
in the thoracic cavity and providing a good view for the thoracic cavity; posterolateral
thoracotomy is the advantages of the incision.
Postoperative pulmonary complications after thoracotomy cause morbidity and mortality.
Although the causes of postoperative pulmonary complication are multifactorial, respiratory
muscle dysfunction is a contributing factor to the development of postoperative pulmonary
complication. This phenomenon has been explained by changes in respiratory muscle mechanics
and operative function. Exercise interventions following lung resection have been shown to be
associated with benefits on functional capacity, quality of life, shoulder pain, and shoulder
function. Physiotherapy interventions have been used regularly since the 1960s for the
prevention and treatment of both pulmonary and musculoskeletal complications following major
surgery. Following thoracotomy, postoperative pulmonary complications are a significant cause
of morbidity and cause significant increase in health care costs, intensive care and hospital
stay, and patient discomfort. Conventional physiotherapy and rehabilitation program applied
after thoracotomy reduces hospital stay and incidence of atelectasis. Early postoperative
pulmonary rehabilitation after lung surgery can improve lung function by increasing
cardiopulmonary and peripheral muscle endurance of patients.
Thoracotomy can also cause long-term limitation of shoulder function and range of motion,
reduced muscle strength, chronic pain, and reduced health-related quality of life.
Physiotherapy program; It provides some benefits such as reduction of pain, improvement of
shoulder function and physical components of quality of life. Based on these findings; It is
recommended that physiotherapists provide a postoperative exercise program aimed at reducing
shoulder dysfunction and pain, including progressive shoulder and rib cage exercises and a
home program after discharge.
In a study, it was found that a postoperative exercise program accompanied by a
physiotherapist provides significant benefits in pain and shoulder functions for patients
after open thoracotomy. During the hospital stay, physiotherapists focus on the prevention
and management of postoperative pulmonary complications and the improvement of patients'
thoracic and shoulder mobility. Among the treatment methods for postoperative pulmonary
complications; breathing exercises consisting of active breathing technique, deep breathing
exercises, incentive spirometry, continuous maximum inspiration, intermittent positive
pressure breathing and positive expiratory pressure devices, cough maneuvers and forced
expiratory technique. In addition, early-stage functional activities such as getting out of
bed, taking steps in place, walking, climbing stairs and cycling have been included as
treatment options for postoperative pulmonary complications and to improve physical function.
Maintaining shoulder and trunk mobility can be achieved with shoulder and trunk range of
motion exercises.
In recent years, the popularity of Tai Chi, Qigong and yoga, also known as body-mind
exercises in the treatment of chronic diseases, has increased.
They are recommended as a category of exercise that includes a range of movements and body
positions, focused on breathing, defined by a calm state of mind and deep relaxation. These
exercises are; It includes many common components such as mind-focused, slow, relaxed,
fluent, respiratory-oriented, and providing deep physical and mental relaxation.
Tai Chi and Qigong exercises are rooted in ancient China, as are traditional Chinese medicine
practices. Originally a spiritual practice, Yoga originated in India. These practices have
been shown to have many health benefits. Many randomized controlled trials such as
fibromyalgia, breast cancer, cardiovascular conditions, and diabetes have focused on the
positive effects of moving meditation on specific medical conditions of various populations.
In addition to conventional physiotherapy and rehabilitation after thoracotomy, Qigong
exercise training applied for 8 weeks; In this study, which was planned to evaluate the
effects on shoulder function, shoulder joint range of motion, shoulder muscle strength,
post-thoracotomy incision pain and shoulder pain, dyspnea respiratory function, respiratory
muscle strength, functional capacity and quality of life, he was hospitalized in Akdeniz
University Hospital Thoracic Surgery clinic and underwent standard posterolateral
thoracotomy. Patients who meet the criteria between 20-70 years of age will be taken. The
control group will consist of patients who received conventional physiotherapy and
rehabilitation in the post-thoracotomy period. The study group, on the other hand, will
consist of patients who underwent qigong exercises in addition to the conventional
physiotherapy and rehabilitation program in the post-thoracotomy period.
Pain, shoulder mobility, shoulder muscle strength, shoulder function, dyspnea, respiratory
function, respiratory muscle strength, respiratory muscle endurance, functional capacity,
quality of life will be evaluated for outcome measures.
Evaluations will be repeated in the preoperative period, postoperative 7th day, postoperative
4th week, and postoperative 8th week.
Conventional physiotherapy and rehabilitation will be applied to all patients participating
in the study.
The program includes progressive ambulation and progressive shoulder and rib cage exercises.
These exercises will be performed under the supervision of a physiotherapist from the first
postoperative day.
The exercises will be advanced every day by increasing the number of repetitions. In addition
to the study group, 8 weeks of Qigong exercise training will be applied.
As a result of the literature study, no study was found that evaluated the effectiveness of
qigong exercise training applied after thoracotomy on shoulder and respiratory functions.
Therefore, in our study; qigong exercise training to be applied in addition to conventional
physiotherapy after thoracotomy; It is thought that it will reduce shoulder and upper
extremity joint range of motion, limitation in shoulder functions, decrease in shoulder
muscle strength, postoperative pulmonary complications, and increase quality of life and
functions.
The hypotheses of the study are as follows. H0: Shoulder and respiratory functions of the
patients who underwent qigong exercise training after thoracotomy were not better than the
control group.
H1: Shoulder and respiratory functions of the patients who underwent qigong exercise training
after thoracotomy were better than the control group.
This study will be performed on patients who will undergo posterolateral thoracotomy surgery
in the Department of Thoracic Surgery of Akdeniz University Medical Faculty Hospital. The
control group will consist of patients who underwent conventional physiotherapy and
rehabilitation in the post-thoracotomy period. The study group will consist of patients who
underwent qigong exercises in addition to the conventional physiotherapy and rehabilitation
program in the post-thoracotomy period.
