- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293429
Combined Posture Correction and Resistive Respiratory Muscles Training in COPD With FHP
Effects of Combined Posture Correction Exercise and Resistive Respiratory Muscle Training on Dyspnea, Chest Expansion, Craniovertebral Angle and Pulmonary Function Test, in COPD Patients With Forward Head Posture
Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms and airflow limitation, often exacerbated by postural abnormalities such as forward head posture (FHP). FHP can lead to significant alterations in breathing patterns, reducing the efficiency of respiratory muscles and impairing lung function. Patients with COPD and FHP frequently exhibit muscular imbalances, where overactive accessory muscles compensate for weakened primary respiratory muscles Resistive Inspiratory Muscle Training strengthens inhalation muscles using resistance devices to enhance respiratory function in COPD patients. Resistive Expiratory Muscle Training focuses on strengthening exhalation muscles through resistance during exhalation, improving breathing efficiency. Posture Correction Exercises address forward head posture by stretching tight muscles and strengthening weak ones to optimize breathing mechanics. Combined Resistive Inspiratory and Expiratory Muscle Training integrates both inspiratory and expiratory muscle training, using resistance for both inhalation and exhalation, to maximize respiratory efficiency and overall lung function in COPD patients. The objective of the study is to determine the effects of combined exercise and resistive respiratory muscles training on dyspnea, chest expansion, craniovertebral angle and pulmonary function test, in COPD patients with forward head posture.
Patients of COPD with forward head posture will be recruited by convenient sampling technique using seal opaque method. 72 patients will be equally divided into three groups with 24 patients each. Posture correction exercises will be added as baseline treatment for all three groups session. GROUP A will be treated with resistive inspiratory muscles training (RIMT). GROUP B will be treated with resistive expiratory muscles training (REMT). GROUP C will be treated with combined resistive inspiratory and expiratory muscles technique (RIMT+REMT).treatment session will be of 8 weeks and will include three reading (pre, post treatment and one follow-up). Outcomes measurement will include; dyspnea by dyspnea 12 questionnaires, chest expansion by measuring tape, craniovertebral angle by radiograph and pulmonary function test by spirometer. Data will be analyzed by SPSS software version 21.
Study Overview
Status
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a widespread, curable, and preventable disease marked by chronic respiratory airway and/or alveolar abnormalities that result in discomfort and airflow limitation; they are usually brought on by prolonged exposure to harmful particles or gases. Even without airflow blockage, there may be serious lung disease (emphysema), making it necessary for a thorough examination. The 4.5 million deaths per year from COPD and related illnesses that are anticipated to occur by 2030 have been extended to approximately 5.4 million deaths per year by 2060.(1) The definition of Chronic Obstructive Pulmonary Disease (COPD) has evolved to encompass a broader understanding beyond just emphysema and chronic bronchitis. Emphysema specifically refers to the destruction of the alveoli, while chronic bronchitis is characterized by a persistent cough and sputum production. However, neither of these terms fully addresses the significant impact of airflow limitation on the morbidity and mortality of COPD patients. It's important to recognize that chronic cough and sputum may occur before airflow limitation develops, and some individuals can experience airflow limitation without these symptoms. This complexity illustrates that COPD includes various structural changes and clinical manifestations, making it inadequate to focus solely on emphysema or chronic bronchitis. A more comprehensive view aids in better diagnosing and managing COPD, ensuring that patients receive care tailored to their unique situations.(2) Symptoms of Chronic Obstructive Pulmonary Disease (COPD) are often perceived as stable in a progressive condition, but recent evidence highlights significant variability in their expression. Breathlessness is the hallmark symptom, yet the overall symptom burden-including cough, sputum production, wheezing, and chest tightness-has a profound negative impact on health status, quality of life, and daily activities. This burden is also associated with increased levels of anxiety and depression, a heightened risk of exacerbations, and worse disease outcomes.
Patients frequently report that morning symptoms, particularly cough and sputum production, are the most severe, correlating with reduced daily functioning and an increased risk of exacerbations. Additionally, nighttime symptoms and sleep disturbances are prevalent but often overlooked in COPD management. These nighttime issues can adversely affect lung function, exacerbate the frequency of episodes, and compromise cardiovascular health, cognition, and overall quality of life.
Moreover, there is considerable variability in symptoms, with many patients experiencing fluctuations on daily, weekly, and seasonal bases. A significant number of individuals report worsening symptoms during the winter months, likely due to environmental factors and increased exposure to respiratory infections. This variability emphasizes the need for personalized management strategies to effectively address the diverse experiences of those living with COPD.(3) Risk factors for Chronic Obstructive Pulmonary Disease (COPD) include a variety of influences that can act independently or interact synergistically. The most critical of these is cigarette smoking, which is the leading cause of chronic bronchitis and emphysema. Other significant contributors include exposure to air pollution and specific occupational hazards. Epidemiological studies have established a strong link between the prevalence of chronic bronchitis and low socioeconomic status. Additionally, endogenous risk factors such as gender, genetic predispositions, childhood respiratory issues, and family history must also be considered in the etiology of COPD.(4) The primary characteristic of Chronic Obstructive Pulmonary Disease (COPD) is persistent expiratory airflow limitation, which leads to air trapping and subsequent hyperinflation. This hyperinflation often develops early in the disease progression and is a key mechanism contributing to exertional dyspnea. Research has indicated that secondary postural changes in the chest wall, along with impaired chest mobility, may arise in response to lung hyperinflation and increased respiratory effort, further compromising the mechanical efficiency of the rib cage's inspiratory muscles.
The treatment algorithm focuses on the ABCD assessment to determine the initial treatment approach. Follow-up management involves adjusting the treatment cycle based on changes in dyspnea or exacerbations, consistent with the 2019 guidelines. The approach to managing persistent dyspnea with add-on bronchodilators and recurrent exacerbations with inhaled corticosteroids aligns with the GOLD 2019 recommendations. The role of inhaled corticosteroids (ICS) has been further clarified in the GOLD 2020 guidelines. Additionally, non-pharmacological treatments, including interventional procedures like endobronchial valves, are recommended based on appropriate indications.(1) Consequently, enhancing postural alignment and the mobility of the chest wall, spine, and shoulders has become a recommended component of comprehensive pulmonary rehabilitation programs. However, the potential effects of such interventions in COPD patients, particularly those with forward head posture, remain uncertain. There is a significant gap in understanding how pulmonary dysfunction interacts with posture and the mobility of the upper body, including the head, cervical and thoracic spines, thorax, and upper limbs.(5) Forward head posture (FHP) is characterized by an anterior deviation of the head in the sagittal plane. This posture is commonly seen in individuals who spend extended periods working at computers or those with chronic conditions. Despite its simplicity, FHP can have significant biomechanical effects on the body. Notably, any changes to the respiratory system can lead to further systemic complications.
Forward head posture (FHP) significantly alters breathing patterns. Ideally, during normal respiration, the chest should expand horizontally, beginning with abdominal breathing rather than chest breathing. In individuals with FHP, overactive sternocleidomastoid (SCM), trapezius, and scalene muscles improperly elevate the clavicles, leading to a dysfunctional upper chest breathing pattern and contributing to muscular imbalances. Research indicates that FHP patients with chronic neck pain exhibit shorter and weaker respiratory muscles compared to healthy individuals. Increased FHP compromises the diaphragm's ability to expand effectively, resulting in reliance on accessory muscles, elevating the ribcage, reducing thoracoabdominal mobility, and impairing diaphragmatic ventilation. As these respiratory muscles become more engaged, alveolar ventilation decreases, and the greater effort required from accessory muscles can lead to fatigue. Muscle imbalance plays a significant role in FHP, which further diminishes lung function, reducing forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak expiratory flow rate (PEFR), and maximal inspiratory and expiratory pressures. Additionally, early FHP can affect muscular strength and stiffness.(6) This review seeks to examine the impact of FHP on breathing function, providing valuable insights for physical medicine and rehabilitation specialists. Understanding how FHP interacts with respiratory health is essential for developing effective management strategies for chronic respiratory disorders, including Chronic Obstructive Pulmonary Disease (COPD). By addressing the connection between posture and respiratory function, we can improve rehabilitation outcomes for patients affected by these conditions.
Forward head posture (FHP) is characterized by an anterior deviation of the head in the sagittal plane. This posture is commonly observed in individuals who spend prolonged periods working at computers or those with chronic conditions. Despite its simplicity, FHP can lead to significant biomechanical effects on the body. Importantly, any alterations to the respiratory system can result in further systemic complications.
Understanding the impact of FHP on breathing function is crucial for physical medicine and rehabilitation specialists. Recognizing how FHP interacts with respiratory health is essential for developing effective management strategies for chronic respiratory disorders, including Chronic Obstructive Pulmonary Disease (COPD). Addressing the connection between posture and respiratory function can enhance rehabilitation outcomes for patients suffering from these conditions.
The presence of forward head posture (FHP) significantly affects the cervical musculature, much of which is involved in the process of labored breathing. Additionally, the protrusion of cervical vertebrae can lead to adaptive changes in the thoracic spine, which in turn may modify the ribcage structure. These changes collectively impact the intercostal muscles, including the diaphragm located near the lower ribcage, ultimately resulting in alterations in both labored and quiet breathing patterns.(7) Postural correction exercises are effective for addressing forward head posture (FHP). To correct this posture, a combination of strengthening and stretching exercises is utilized. These exercises target imbalances in the underlying soft tissues by stretching the cervical and pectoral muscles while strengthening the deep cervical flexors and shoulder retractors. This management approach is recommended to enhance postural alignment. Studies indicate that a 4-week exercise intervention, conducted four times a week, significantly improved postural parameters such as craniovertebral (CV) angle, active neck flexion range of motion, and lower trapezius muscle strength in patients with FHP. Thus, a regimen of stretching and strengthening exercises is sufficient to correct FHP and enhance neck range of motion and muscle strength.(8) Resistive inspiratory muscle training (RIMT) has been shown to improve inspiratory muscle function, increase lung volumes, and boost exercise capacity in healthy individuals, as well as in several patient populations.(9) Resistive inspiratory muscle training (RIMT) is a valuable component of COPD rehabilitation programs. This technique is particularly beneficial as it improves both the strength (Maximal Inspiratory Pressure) and endurance (Maximal Voluntary Ventilation) of respiratory muscles, leading to a reduction in prominent clinical symptoms such as dyspnea.(10) Resistive expiratory muscle training has been shown to yield greater improvements in ventilatory measures compared to other forms of expiratory muscle training. Strengthening the muscles involved in expiration can enhance cough strength, providing a straightforward and cost-effective approach to improving coughing efficacy. By using a simple handheld breathing training device for repeated expiratory resistance exercises, there is potential to increase maximal expiratory pressure and other important ventilatory function metrics. Ultimately, expiratory resistance training may help reduce respiratory morbidity.(11) The main focus of the study is to examine the effects of combined posture correction exercises and resistive respiratory muscle training-encompassing both resistive inspiratory and expiratory muscle training-on patients with Chronic Obstructive Pulmonary Disease who also present with forward head posture. By focusing on the dual approach of enhancing respiratory muscle strength and correcting postural deviations, this research seeks to elucidate the relationship between optimal posture and respiratory function. The findings may offer critical insights for clinicians, supporting the integration of resistive respiratory muscle training into pulmonary rehabilitation programs. This approach could not only optimize patient outcomes but also reduce healthcare costs associated with chronic obstructive pulmonary disease exacerbations. Furthermore, this research aims to elevate the crucial role of both resistive inspiratory and expiratory muscle training in managing respiratory health, laying the groundwork for future investigations into comprehensive treatment strategies for chronic respiratory conditions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: wajeeha zia, PP-DPT
- Phone Number: 0323 4500788
- Email: wajeeha.zia@riphah.edu.pk
Study Contact Backup
- Name: Imran amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjab@riphah.edu.pk
Study Locations
-
-
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Lahore, Pakistan, 54000
- Recruiting
- Riphah International University
-
Contact:
- wajeeha zia, phd
- Phone Number: 0323 4500788
- Email: wajeeha.zia@riphah.edu.pk
-
Contact:
- Email: wajeeha_z@yahoo.com
-
Principal Investigator:
- Wajeeha Zia, phd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Patients of COPD at stage 1 and 2
- COPD with forward head posture.
- Craniovertebral angle < 53 degrees (20)
- Age 40-60
- Both genders
- Spirometric evidence of significant chronic air-flow limitation (ie, FEV1 of 50% of predicted and FEV1/FVC ratio of 70% of predicted) in whom COPD had been diagnosed (21)
- Persistent dyspnea with a self-rated intensity of ⩾6 (out of 10) on a visual analogue
- Having muscular tightness (pectoralis major and minor, upper trapezius, sternocleidomastoid)
Exclusion Criteria:
• COPD with severe complications (respiratory infections, acute exacerbations, pulmonary hypertension)
- COPD with cardiovascular complications (Cor Pulmonale, atherosclerosis, risk of venous thromboembolism)
- Unstable respiratory, neurological, and cardiovascular conditions
- Congenital Cervical/spinal deformity
- Patients with frozen shoulder, shoulder, cervical radiculopathy)
- Uncontrolled underlying conditions(22)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resistive inspiratory muscles training
GROUP A: will be treated with resistive inspiratory muscles training along with posture correction exercises
|
Resistive Inspiratory Muscle Training (IMT) will be implemented using a threshold inspiratory muscle trainer, which requires patients to inhale through a one-way valve that provides adjustable resistance.
The training sessions will begin with patients sitting comfortably in an upright position to optimize lung function.
They will be instructed to take a deep breath, ensuring their diaphragm engages fully, and then inhale through the device, which will resist airflow, thereby increasing the workload on the inspiratory muscles.
Initially, the resistance will be set at a level that is challenging yet achievable, with the aim to gradually increase resistance as the patient's strength and endurance improve.
Each session will last 30 minutes, consisting of intervals of resisted inhalation followed by brief rest periods.
Patients will perform 3 sets of 10 breaths with appropriate breaks in between.
The training will be conducted 3 times per week,
|
|
Experimental: Resistive expiratory muscles training
GROUP B: will be treated with Resistive expiratory muscles training along with posture correction exercises
|
Resistive Expiratory Muscle Training (EMT) will be employed to enhance the strength and endurance of the expiratory muscles in COPD patients.
This training will utilize a threshold expiratory muscle trainer, designed to provide resistance during exhalation, thereby engaging the abdominal and intercostal muscles effectively.
Patients will begin each session in a comfortable, upright position to optimize lung function.
They will be instructed to take a deep inhalation to fully expand their lungs, and then exhale forcefully through the device against the resistance.
The resistance level will be adjustable and initially set to a manageable level, with plans to gradually increase it as the patient's strength improves.
Each training session will last 30 minutes, consisting of intervals of resisted exhalation followed by brief recovery periods.
Patients will perform 3 sets of 10 breaths, with appropriate breaks in between.
it will be performed 3 times per week
|
|
Experimental: Combined resistive inspiratory and expiratory muscles training
GROUP C: will be treated with Combined resistive inspiratory and expiratory muscles training along with posture correction exercises
|
Resistive Inspiratory Muscle Training (IMT) will be implemented using a threshold inspiratory muscle trainer, which requires patients to inhale through a one-way valve that provides adjustable resistance.
The training sessions will begin with patients sitting comfortably in an upright position to optimize lung function.
They will be instructed to take a deep breath, ensuring their diaphragm engages fully, and then inhale through the device, which will resist airflow, thereby increasing the workload on the inspiratory muscles.
Initially, the resistance will be set at a level that is challenging yet achievable, with the aim to gradually increase resistance as the patient's strength and endurance improve.
Each session will last 30 minutes, consisting of intervals of resisted inhalation followed by brief rest periods.
Patients will perform 3 sets of 10 breaths with appropriate breaks in between.
The training will be conducted 3 times per week,
Resistive Inspiratory and Expiratory Muscle Training will be implemented concurrently as a comprehensive approach to enhance the strength and endurance of both inspiratory and expiratory muscles in COPD patients.
During each session, patients will utilize a threshold inspiratory muscle trainer for inhalation while simultaneously using a threshold expiratory muscle trainer for exhalation.
Each training session will last 20-30 minutes, beginning with patients taking a deep breath to fully engage their diaphragm before inhaling through the inspiratory trainer and exhaling forcefully against the resistance of the expiratory trainer.
Patients will perform 3 sets of 10 breaths, with appropriate breaks in between to prevent fatigue and ensure effective training.
This resistive EMT protocol will be conducted 3 times per week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea-12 questionnaire:
Time Frame: pretreatment, 4th week, 8th week
|
The Dyspnoea-12 (D-12), particularly evaluates both the physical and emotional components of dyspnea, was created to provide a quick, reliable assessment that is applicable to a wide range of cardiorespiratory conditions. Twelve items on the D-12 measure dyspnea on a four-point scale from none to mild, moderate, and severe. The physical domain is the sum of the scores for the first seven items, which range from 0 to 21. The affective domain scores, which range from 0 to 15, are the sum of the remaining five items. The D-12 total scores, which range from 0 to 36, are the sum of the twelve items. Severity can be determined by higher scores. The test provided significant evidence of assessing characteristics such as construct validity, internal consistency, and structural validity in the Norwegian-language D-12 |
pretreatment, 4th week, 8th week
|
|
Measuring tape
Time Frame: pretreatment, 4th week, 8th week
|
The tape measure is a conventional instrument used to assess chest expansion. It measures circumferentially at predetermined spots on the chest wall. Assuring that the underlying soft tissues have not been compressed will assist in helping the tape conform to the chest wall. (24) A tape is used at two distinct rib cage positions to quantify chest expansion. Three anatomical landmarks for thoracic expansion will be the angle of Louis on sternum, xiphoid process of mid chest expansion, midpoint between the xiphoid process and umbilicus for lower chest expansion. Measurements of chest expansion performed with a tape on the upper and lower thoracic levels have a strong relationship and exhibit good intra- and inter-rater reliability and consistency. |
pretreatment, 4th week, 8th week
|
|
Radiograph
Time Frame: pretreatment, 4th week, 8th week
|
One of the common objective methods for evaluating head posture is the measurement of craniovertebral (CV) angle. It is the angle formed when a line drawn horizontally through the seventh cervical (C7) vertebra's spinous process and a line connecting it to the tragus of ear. Radiographic measurements play a crucial role in assessing cervical spine alignment in the sagittal plane by evaluating the relative positions of the vertebrae and joints |
pretreatment, 4th week, 8th week
|
|
Spirometer
Time Frame: pretreatment, 4th week, 8th week
|
A spirometer is a device that measures the amount of air that a person can inhale and exhale during a predetermined period of time.
This measurement is typically performed to diagnose lung diseases, specifically blockage and reorganization, forced vital capacity (FVC), and forced expiratory volume in one second (FEV1) are a few spirometer characteristics that are utilized for clinical assessment.
The existence or lack of anomalies in the lung can be detected using two of the three measures.
Spirometry is an easy, safe, non-invasive, and reasonably priced diagnostic tool for identifying airflow blockage.
Spirometry, one of the currently available methods for the early detection of asthma and COPD, is therefore very crucial.
It is advised that patients with asthma and COPD measure their static and dynamic respiratory functions every day in order to easily monitor their lung health and avoid exacerbations.
|
pretreatment, 4th week, 8th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
COPD assessment test (CAT)
Time Frame: pretreatment, 4th week, 8th week
|
The COPD Assessment Test (CAT) will be used to evaluate the quality of life in all participants.
It is expected to serve as a straightforward and effective tool for assessing the health status of Thai COPD patients.
The CAT consists of eight questions that address various aspects of the disease, including dyspnea, cough, sputum production, wheezing, fatigue, sleep disturbances, limitations in daily activities, social life, emotional well-being, and a sense of control.
The CAT score ranges from 0 to 40, with the following classifications: a score of <10 indicates a low impact on health status, 11-20 indicates a moderate impact, 21-30 indicates a high impact, and >30 indicates a very high impact on health status.
|
pretreatment, 4th week, 8th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wajeeha Zia, PP-DPT, Riphah International University
Publications and helpful links
General Publications
- Gupta N, Agrawal S, Chakrabarti S, Ish P. COPD 2020 Guidelines - what is new and why? Adv Respir Med. 2020;88(1):38-40. doi: 10.5603/ARM.2020.0080. No abstract available.
- Garratt AM, Nerheim EM, Einvik G, Stavem K, Edvardsen A. Evaluation of the Norwegian version of the Dyspnoea-12 questionnaire in patients with COPD. BMJ Open Respir Res. 2022 May;9(1):e001262. doi: 10.1136/bmjresp-2022-001262.
- Ray AD, Udhoji S, Mashtare TL, Fisher NM. A combined inspiratory and expiratory muscle training program improves respiratory muscle strength and fatigue in multiple sclerosis. Arch Phys Med Rehabil. 2013 Oct;94(10):1964-70. doi: 10.1016/j.apmr.2013.05.005. Epub 2013 May 25.
- Vazquez-Gandullo E, Hidalgo-Molina A, Montoro-Ballesteros F, Morales-Gonzalez M, Munoz-Ramirez I, Arnedillo-Munoz A. Reply to Yigit, S.; Akinci, B. Comment on "Vazquez-Gandullo et al. Inspiratory Muscle Training in Patients with Chronic Obstructive Pulmonary Disease (COPD) as Part of a Respiratory Rehabilitation Program Implementation of Mechanical Devices: A Systematic Review. Int. J. Environ. Res. Public Health 2022, 19, 5564". Int J Environ Res Public Health. 2023 Mar 9;20(6):4801. doi: 10.3390/ijerph20064801.
- Postma K, Haisma JA, Hopman MT, Bergen MP, Stam HJ, Bussmann JB. Resistive inspiratory muscle training in people with spinal cord injury during inpatient rehabilitation: a randomized controlled trial. Phys Ther. 2014 Dec;94(12):1709-19. doi: 10.2522/ptj.20140079. Epub 2014 Jul 31.
- Morais N, Cruz J, Marques A. Posture and mobility of the upper body quadrant and pulmonary function in COPD: an exploratory study. Braz J Phys Ther. 2016 Jul-Aug;20(4):345-54. doi: 10.1590/bjpt-rbf.2014.0162. Epub 2016 Apr 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kaynat saleem
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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