Clinical trial NCT05470192: The Effects of Qigong Exercise Training After Thoracotomy
Official title: The Effects of Qigong Exercise Training on Shoulder and Respiratory Function After Thoracotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Shoulder
Postoperative Pain
Joint Adhesion
Muscle Weakness
Respiratory Function Loss
Quality of Life
Keywords: Thoracotomy
Qigong exercise training
Shoulder function
Respiratory function
Quality of life
Pain
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Posterolateral thoracotomy surgery
* Hemodynamically stable
* Who agreed to participate in the study

Exclusion Criteria:

* Decortication, undergoing thoracic wall surgery
* Patients with known cerebrovascular disease and related neurologic involvement
* Using any device for ambulation
* Those who have undergone shoulder surgery within 6 months
* Those with cognitive dysfunction (Mini Mental Test score \<24)

Primary outcomes:
measure: Change of Pain Score
timeFrame: Change from Baseline Pain Score at 8 weeks.
measure: Change of Active Shoulder Range of Motion
timeFrame: Change from Baseline Active Shoulder Range of Motion at 8 weeks.
measure: Change of Shoulder Muscle Strength
timeFrame: Change from Baseline Shoulder Muscle Strength at 8 weeks.
measure: Change of Pulmonary Function
timeFrame: Change from Baseline Pulmonary Function at 8 weeks.
measure: Change of Respiratory Muscle Strength
timeFrame: Change from Baseline Respiratory Muscle Strength at 8 weeks.
measure: Change of Respiratory Muscle Endurance
timeFrame: Change from Baseline Respiratory Muscle Endurance at 8 weeks.
measure: Change of Functional Capacities
timeFrame: Change from Baseline Functional Capacities at 8 weeks.
measure: Change of Basal Dyspnea Index Score
timeFrame: Change from Baseline of Basal Dyspnea Index Score at 8 weeks.
measure: Change of Quality of Life Score
timeFrame: Change from Baseline Quality of Life Score at 8 weeks.
measure: Change of Shoulder, Pain and Disability Index Score
timeFrame: Change from Baseline Shoulder, Pain and Disability Index Score at 8 weeks.
Secondary outcomes:
measure: Height in Meters
timeFrame: Initial assessment before surgery
measure: Weight in Kilograms
timeFrame: Initial assessment before surgery
measure: Body Mass Index (BMI) in kg/m^2
timeFrame: Initial assessment before surgery
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Neriman Temel Aksu
Study officials:
affiliation: Akdeniz Üniversitesi
name: Neriman T Aksu
role: PRINCIPAL_INVESTIGATOR
References: