An interventional study of Resistive inspiratory muscles training and Resistive expiratory muscles training: in COPD - Chronic Obstructive Pulmonary Disease and Forward Head Posture, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Riphah International University · Not applicable, Interventional, and Treatment
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 72 is close to the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
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Patients of COPD at stage 1 and 2
Exclusion Criteria:
COPD with severe complications (respiratory infections, acute exacerbations, pulmonary hypertension)
GROUP A: will be treated with resistive inspiratory muscles training along with posture correction exercises
Device: Resistive inspiratory muscles training
GROUP B: will be treated with Resistive expiratory muscles training along with posture correction exercises
Device: Resistive expiratory muscles training:
GROUP C: will be treated with Combined resistive inspiratory and expiratory muscles training along with posture correction exercises
Device: Resistive inspiratory muscles training · Device: Combined resistive inspiratory and expiratory muscles training
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 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
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
Dyspnea-12 questionnaire:
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
Time frame: pretreatment, 4th week, 8th week
Measuring tape
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.
Time frame: pretreatment, 4th week, 8th week
Radiograph
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
Time frame: pretreatment, 4th week, 8th week
Spirometer
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.
Time frame: pretreatment, 4th week, 8th week
COPD assessment test (CAT)
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.
Time frame: pretreatment, 4th week, 8th week
Plan to share: No
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