Comparison of 6-Week Intervention of MAGIC Physiotherapy Protocol with Conventional Physiotherapy in COPD : A Randomized Controlled Trial

INTRODUCTIONChronic Obstructive Pulmonary Disease (COPD) is a rising universal problem. Extrapulmonary comorbidities are common in COPD and significantly contribute to mortality, symptoms, exacerbations, and hospital admissions. The frequency of exacerbation and the presence and severity of symptoms have been stated as two important factors in the progression of COPD. Therefore, reduction of symptoms and exacerbation will slow down the progression of the disease. Also, the restructured classical pulmonary system-centered definition of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) emphasizes the importance of extrapulmonary conditions in COPD patients and their clinics. Although cardiac, metabolic, musculoskeletal, and psychological conditions are among these extrapulmonary conditions, musculoskeletal dysfunction (thirty-two percent) is one of the most common extrapulmonary comorbidities in patients with COPD. Dysfunctions such as inspiratory muscle weakness, reduced respiratory muscle endurance, changes in chest wall mechanics and the position of the diaphragm due to hyperinflation, increased tension of the respiratory muscles, and spinal hypomobility cause impaired exercise capacity, increased dyspnea, increased effort required to breathe, and poorer quality of life. Respiratory dysfunction in patients with COPD has been associated with compensatory alterations in the length and mobility of the chest, thoracic spine, and shoulder muscles. Chronic Obstructive Pulmonary Disease (COPD) is a significant public health concern in India, with varying prevalence rates reported across different studies. A systematic review and meta-analysis focusing on individuals aged thirty years and above estimated the overall prevalence of COPD in this age group to be seven percent. Evidence also suggests that manual therapy (MT) has the potential to alter respiratory mechanics in certain chronic respiratory diseases, and there are published studies describing the use of MT techniques. MT covers a range of techniques, including diaphragmatic release and joint mobilization or manipulation. Increasing thoracic mobility with MT techniques may work to reduce the work of breathing through enhanced oxygen transport and lymphatic return, while enhanced local circulation, improved nutrition of tissues, and muscle relaxation help generate much more respiratory muscle force. Studies focusing on physical activity for COPD patients offer immense benefits, including improved respiratory function, enhanced quality of life, reduced hospital admissions, and better disease management. Integrating physical activity programs into COPD treatment plans can lead to better patient outcomes, improved healthcare efficiency, and overall improved quality of life. A recent randomized controlled trial conducted in 2018 evaluated the impact of a quick relaxation exercise, which included elements of guided imagery, on individuals with COPD. The study found that while relaxation techniques may offer benefits such as reduced anxiety and improved oxygen saturation in some COPD patients, the evidence is not consistent across all studies. The authors concluded that further well-designed, large-scale randomized controlled trials are necessary to conclusively determine the efficacy of guided imagery as a therapeutic intervention for COPD. Early intervention prompts treatment initiation to manage symptoms and slow disease progression. Comprehensive care includes smoking cessation, patient education, and lifestyle changes to improve outcomes.

NEED FOR THE STUDYChronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory condition characterized by airflow limitation, leading to symptoms such as dyspnea, reduced exercise tolerance, and diminished quality of life. Physiotherapy interventions are integral to pulmonary rehabilitation, aiming to alleviate these symptoms and enhance functional outcomes. The proposed study seeks to evaluate the effectiveness of the MAGIC physiotherapy protocol comprising Manual therapy, Activity, Guided imagery, Inspiratory and Expiratory Exercises, Incentive Spirometer, and Care compared to conventional physiotherapy in improving functional outcomes in COPD patients over a six-week intervention period. Manual therapy involves hands-on techniques to mobilize joints and soft tissues, potentially improving chest wall mobility and respiratory function. A study demonstrated that combining manual therapy led to significant improvements in pulmonary function, functional capacity, and quality of life. Engaging in regular physical activity is crucial for COPD management. Physical therapists design exercise programs to enhance breathing efficiency, increase activity tolerance, and reduce fatigue. Such interventions have been shown to improve shortness of breath and quality of life. Guided imagery is a relaxation technique that may help reduce anxiety and improve well-being in COPD patients. Research indicates that guided imagery can positively affect the psychological state of individuals with COPD, potentially leading to better disease management. Inspiratory and expiratory exercises focus on strengthening the respiratory muscles, which can lead to improved inspiratory muscle strength, reduced dyspnea, and enhanced quality of life. Comprehensive care, including patient education and self-management strategies, is vital for effective COPD management. Physical therapists play a key role in educating patients to improve symptoms and restore strength in breathing muscles. While individual components of the MAGIC protocol have demonstrated benefits in COPD management, there is limited research evaluating the combined effect of these interventions as a cohesive program. Assessing the efficacy of the MAGIC protocol compared to conventional physiotherapy could provide valuable insights into optimizing rehabilitation strategies for COPD patients. This study aims to determine whether the integrative approach of the MAGIC protocol offers superior improvements in functional outcomes, thereby informing clinical practice and potentially leading to better patient care.

RESEARCH QUESTIONWhat will be the effect of a six-week intervention of the MAGIC Physiotherapy Protocol compared with Conventional Physiotherapy in COPD patients?

AIM AND OBJECTIVESAim: To find the effectiveness of a six-week intervention of the MAGIC Physiotherapy Protocol compared with Conventional Physiotherapy in COPD patients. Objectives: 1. To find out the efficacy of the MAGIC Physiotherapy Protocol compared with Conventional Physiotherapy in improving functional outcomes in COPD patients over a six-week intervention period using peak flow meter, breath hold test, MMRC scale, and CAT COPD questionnaire. 2. To find the efficacy of Conventional Physiotherapy in improving functional outcomes in COPD patients over a six-week intervention period using peak flow meter, breath hold test, MMRC scale, and CAT COPD questionnaire. 3. To compare the effects of a six-week intervention of the MAGIC Physiotherapy Protocol with Conventional Physiotherapy in COPD patients using peak flow meter, breath hold test, MMRC scale, and CAT COPD questionnaire.

HYPOTHESESNull Hypothesis (H0): There is no significant difference between a six-week intervention of the MAGIC Physiotherapy Protocol and Conventional Physiotherapy in COPD patients. Alternative Hypothesis (H1): There is a significant difference between a six-week intervention of the MAGIC Physiotherapy Protocol and Conventional Physiotherapy in COPD patients.

MATERIAL AND METHODOLOGYStudy Setting: Department of Cardiorespiratory Physiotherapy, Dr. A.P.J. Abdul Kalam College of Physiotherapy, Loni. Study Type: Experimental study. Study Design: Randomized controlled trial. Study Duration: Two years. Sampling Method: Simple random sampling. Sample Size: Forty-four (calculated using OpenEpi software).

OUTCOME MEASURESPrimary Outcomes: 1. Peak Expiratory Flow Rate (reliability 0.7). 2. Breath Hold Test (reliability 0.8). Secondary Outcomes: 1. Modified Medical Research Council Dyspnea Scale (reliability 0.75). 2. COPD Assessment Test (reliability 0.8).

ELIGIBILITY CRITERIAInclusion Criteria: - Patients with a confirmed diagnosis of COPD, classified as mild or moderate based on GOLD criteria. - PEFR in mild COPD: 400 to 500 L/min; moderate COPD: 300 to 400 L/min. - Breath hold test: mild COPD – 30 to 40 seconds; moderate COPD – 20 to 30 seconds. - Both male and female patients. - Adults aged 40 to 75 years. - Clinically stable condition. - Ability to provide written informed consent and willingness to participate in the full duration of the study. Exclusion Criteria: - Patients with severe or very severe COPD (GOLD stage 3 or 4) or other coexisting respiratory conditions such as asthma, bronchiectasis, or interstitial lung disease. - Thoracic spinal scoliosis, substantial chest wall deformity, acute rib or vertebral fracture. - History of thoracic or abdominal surgery, or hospitalizations for any reason within the last three months. - Cognitive impairments or psychiatric conditions. - Unstable medical condition.

PROCEDUREThe protocol will be prepared and ethical clearance will be obtained from the Institutional Ethics Committee. Participants will be selected based on eligibility criteria. Informed consent will be obtained, and demographic data will be recorded. Participants will be randomly allocated to two groups: - Experimental Group A (n = 22): MAGIC protocol along with conventional physiotherapy. - Control Group B (n = 22): Conventional physiotherapy only. Both groups will undergo prior assessment. The intervention will consist of exercise regimens administered for 30 minutes per session, three days per week, for six weeks. Respiratory muscle strength, PEFR, level of dyspnea, and quality of life will be measured using the Breath Hold Test, Peak Flow Meter, MMRC scale, and CAT COPD questionnaire. Statistical analysis will be performed, and results will be calculated.

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