The Effects of Qigong Exercise Training After Thoracotomy

NCT05470192 | Completed

• 1 other identifier: AU
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (10)

• Change of Pain Score

  The person is asked to rate their pain between 0 and 10 (0=Absence of Pain, 10=The Most Unbearable Pain). Numerical Pain Rating Scale is frequently used because of its ease of use. The scale can be completed in 1 minute. Three pain regions will be evaluated in this study. These regions; the incision line (along the incision or within the two intercostal spaces above or below), over the rib cage (outside the incision site), and the shoulder joint complex (upper extremity and trapezius muscle near the middle humerus, including the clavicular and scapular areas). They will be asked to score and indicate numerically between 0 and 10 points. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.

  Change from Baseline Pain Score at 8 weeks.

• Change of Active Shoulder Range of Motion

  Active shoulder range of motion of the patients will be evaluated with a digital goniometer (Baseline Digital Absolute \& Axis Goniometer) using a standard protocol. Total shoulder motion that allows motion of all joints in the shoulder complex will be measured, glenohumeral motion will not be isolated. Flexion, abduction, external and internal rotation of the shoulder will be evaluated. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.

  Change from Baseline Active Shoulder Range of Motion at 8 weeks.

• Change of Shoulder Muscle Strength

  Shoulder muscle strength will be measured using a dynamometer (MicroFET 2 Manual Muscle Tester). Force measurements will be taken for shoulder flexion, abduction, internal and external rotation. Before starting the test, patients will be informed about how to perform the test. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.

  Change from Baseline Shoulder Muscle Strength at 8 weeks.

• Change of Pulmonary Function

  The Pulmonary Function Test will be performed with the COSMED Pony FX (COSMED; Italy) spirometer in accordance with the criteria of the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Forced vital capacity (FVC), Forced expiratory volume in 1 second (FEV1), Tiffeneau ratio (FEV1/FVC), Forced expiratory flow 25-75% (FEF25-75%) and peak expiratory flow rate (PEF) values and predictive values percentage will be recorded. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.

  Change from Baseline Pulmonary Function at 8 weeks.

• Change of Respiratory Muscle Strength

  Respiratory muscle strength measurement will be performed with a portable, electronic intraoral pressure measuring device COSMED Pony FX (COSMED; Italy) according to ATS/ERS criteria. The MIP will be measured at residual volume and during deep inspiration. MEP will be determined at total lung capacity and during deep expiration. Measurements will be made in a sitting position using a nose clip. Patients will be verbally encouraged for the best strength. Measurement will be made until it provides the valid value in patients. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.

  Change from Baseline Respiratory Muscle Strength at 8 weeks.

• Change of Respiratory Muscle Endurance

  Respiratory Muscle Endurance will be performed by COSMED Pony FX (COSMED; Italy) spirometry by applying the maximal voluntary ventilation (MVV) procedure in accordance with the criteria of the American Thoracic Society (ATS) and the European Respiratory Society (ERS). The patient will be asked to breathe deeper and faster than the resting tidal volume for 12 seconds. When the test is finished after 12 seconds, the device will show the predictive value of MVV % that we used in our study. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.

  Change from Baseline Respiratory Muscle Endurance at 8 weeks.

• Change of Functional Capacities

  The functional capacities of the patients will be measured with the 6-minute walking test. Before testing, patients will rest for 10 minutes. Before starting the test, patients should be told if they feel too short of breath during the test; It will be explained that they can slow down, stop and rest, and this time will be included in the test. Patients will be asked to walk as fast as possible at their own walking pace for 6 minutes on a 30-meter straight corridor. Fatigue and dyspnea perception will be assessed with the Modified Borg Scale. The Modified Borg Scale was developed to measure the effort spent during exercise and is a scale that is frequently used to evaluate the severity of exertional dyspnea and the severity of dyspnea at rest. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.

  Change from Baseline Functional Capacities at 8 weeks.

• Change of Basal Dyspnea Index Score

  Basal Dyspnea Index will be applied to evaluate the dyspnea status of the patients. Basal Dyspnea Index (Baseline Dyspnea Index, BDI): BDI is a scale developed to evaluate dyspnea due to activity. Its Turkish validity and reliability have been established by different researchers. The scale consists of three sub-dimensions: functional status (level of performing activities of daily living), effort capacity (difficult efforts to perform activities), and work capacity. Each sub-dimension is scored between 0 (very severe impairment) and 4 (no impairment). The total score ranges from 0 to 12, and as the score decreases, the severity of dyspnea increases. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.

  Change from Baseline of Basal Dyspnea Index Score at 8 weeks.

• Change of Quality of Life Score

  The quality of life of our patients will be evaluated using the Short Form-12. Health-related quality of life refers to the function and well-being of the physical, mental and social dimensions of life. SF-12 are among the most used multi-element health-related quality-of-life instruments. Preoperative period, postoperative 4th week and postoperative 8th week will be repeated.

  Change from Baseline Quality of Life Score at 8 weeks.

• Change of Shoulder, Pain and Disability Index Score

  Shoulder function will be measured using the Shoulder, Pain and Disability Index , a self-rated questionnaire designed to measure shoulder pain and disability. Shoulder Pain and Disability Index is a reliable questionnaire evaluating shoulder pain and disability. Turkish reliability and validity were performed by Bumin et al. in 2008. There are 2 subscales and 13 items in total in the index. 5 of them evaluate pain and 8 evaluate disability. The items of both subscales are measured with a visual analog scale from 0 to 10. The scores given by the individual are added together and calculated as a percentage. Higher scores indicate more severe pain and higher disability. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated

  Change from Baseline Shoulder, Pain and Disability Index Score at 8 weeks.

Secondary Outcomes (3)

• Height in Meters

  Initial assessment before surgery

• Weight in Kilograms

  Initial assessment before surgery

• Body Mass Index (BMI) in kg/m^2

  Initial assessment before surgery

Study Arms (2)

Qigong Exercise Training and Conventional Physiotherapy and Rehabilitation Group

EXPERIMENTAL

In addition to the conventional physiotherapy and rehabilitation program, qigong exercise training will be given to the qigong exercise training group by a certified physiotherapist who has received qigong training.

Other: Qigong exercise training

Conventional Physiotherapy and Rehabilitation Group

NO INTERVENTION

A training will be given including information about the postoperative recovery process, the purpose of respiratory physiotherapy and rehabilitation, the importance of physiotherapy and rehabilitation in the postoperative period, attention to speed up recovery and prevention of complications, breathing exercises, coughing training, posture exercises, early mobilization and its importance, and answering patient questions. . 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.

Interventions

Qigong exercise training OTHER

Before and after the qigong exercises, 10-minute exercises will be done to stretch the large muscle groups for warm-up-cooling purposes. The entire Baduanjin exercise consists of 8 postures: preparation position 1. Raising arms with palms up, 2. Shooting arrows left and right like an archer in a semi-crouching position 3. Keeping one arm up 4. Looking back with trunk rotations in a semi-crouching position 5. Nodding the head and lowering the body to relieve stress, 6. Fisting and staring 7. Touching feet with hands touching back and legs 8. Raising and lowering heels

Also known as: Therapeutic Baduanjin Qigong Exercises

Qigong Exercise Training and Conventional Physiotherapy and Rehabilitation Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Neriman Temel Aksu

Antalya, 07060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Pain; Pain, Postoperative; Muscle Weakness; Respiratory Aspiration; Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Muscular Diseases; Neuromuscular Manifestations; Nervous System Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Neriman T Aksu

  Akdeniz Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant (Expert Physiotherapist)

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 22, 2022
• Study Start: October 28, 2022
• Primary Completion: October 30, 2022
• Study Completion: November 1, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

TU (1)