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CTRI Number  CTRI/2025/09/095335 [Registered on: 24/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of MAGIC Protocol with Physiotherapy in COPD Patients 
Scientific Title of Study   Comparison of 6-Week Intervention of MAGIC Physiotherapy Protocol with Conventional Physiotherapy in COPD : A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DURVA MANOJ DESHMUKH 
Designation  postgraduate student 
Affiliation  pravara institue of medical sciences loni 
Address  505, Department of Cardiorespiratory physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736 Ahmadnagar MAHARASHTRA 413736 India
505, Department of Cardiorespiratory physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736 Ahmadnagar MAHARASHTRA 413736 India
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9403377505  
Fax    
Email  Durvadeshmukh5073@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrMadhur Kulkarni PT 
Designation  Associate Professor 
Affiliation  pravara institue of medical sciences loni 
Address  505, Department of Cardiorespiratory physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736 Ahmadnagar MAHARASHTRA 413736 India
505, Department of Cardiorespiratory physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736 Ahmadnagar MAHARASHTRA 413736 India
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7588009063  
Fax    
Email  madhurkulkarni19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrMadhur Kulkarni PT 
Designation  Associate Professor 
Affiliation  pravara institue of medical sciences loni 
Address  505, Department of Cardiorespiratory physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736 Ahmadnagar MAHARASHTRA 413736 India
505, Department of Cardiorespiratory physiotherapy, Dr.A.P.J Abdul Kalam College of Physiotherapy ,Pravara Institute of Medical Sciences, Loni, 413736 Ahmadnagar MAHARASHTRA 413736 India

MAHARASHTRA
413736
India 
Phone  7588009063  
Fax    
Email  madhurkulkarni19@gmail.com  
 
Source of Monetary or Material Support  
Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni,413736 
 
Primary Sponsor  
Name  Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS , Loni 
Address  Pravara Institute of Medical Sciences, Dr. A.P.J Abdul Kalam College of Physiotherapy , Loni, 413736 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Durva M Deshmukh  Dr. A.P.J Abdul Kalam College of Physiotherapy  Department of cardiorespiratory phsiotherapy ,room no.503,Pravara Institute of Medical Sciences, Dr. A.P.J Abdul Kalam College of Physiotherapy , Loni, 413736 Ahmadnagar MAHARASHTRA,INDIA
Nashik
MAHARASHTRA 
9403377505

Durvadeshmukh5073@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Dr. APJAK COPT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparison of 6-Week Intervention of MAGIC Physiotherapy Protocol with Conventional Physiotherapy in COPD A Randomized Controlled Trial  MAGIC Physiotherapy Protocol for COPD: A Structured 6-Week Program Note: The protocol should be implemented exclusively under the supervision of a therapist for each weekly session. Weeks 1–2 M - Manual Therapy Diaphragmatic release and thoracic spine mobilization Frequency: 2–3x/week | Time: 15–20 min | Intensity: Mild–moderate A - Activity Aerobic: Walking or cycling (60–70% HRmax, 20–30 min, 3x/week) Strength: Large muscle groups, 1–2 sets, Very light resistance (RPE 9), 20–30 min, 3x/week G - Guided Imagery Breathing-focused visualization Daily, 10–15 min, relaxation techniques I - Inspiratory & Expiratory Exercises + Incentive Spirometer Diaphragmatic Breathing, Pursed-lip Breathing, Incentive Spirometer Frequency: 4x/week, 10 reps x 1 set C - Care Patient education, counseling, emotional support, lifestyle changes Rehabilitation Goals Improve diaphragm & thoracic mobility Enhance endurance & functional strength Reduce anxiety & improve breathing efficiency Build awareness, adherence, and emotional support Weeks 3–4 M - Manual Therapy Continue diaphragmatic release and thoracic mobilization A - Activity Aerobic: 65–75% HRmax, 20–30 min, 4x/week Strength: Light resistance, RPE 9–11, 2 sets of 10–12 reps, 3x/week G - Guided Imagery Daily calmness visualization I - Inspiratory & Expiratory Exercises + Incentive Spirometer Diaphragmatic Breathing, Pursed-lip Breathing, Incentive Spirometer Frequency: 4x/week, 10 reps x 1 set C - Care Monitor progress and provide feedback Rehabilitation Goals Maintain diaphragm mobility Enhance muscle endurance & strength Reduce stress, optimize breathing Progressively strengthen inspiratory/expiratory muscles Ensure adherence & address challenges Weeks 5–6 M - Manual Therapy Focus on diaphragm relaxation & thoracic mobility A - Activity Aerobic: 70–75% HRmax, 40–60 min, 4x/week Strength: Moderate resistance, RPE 12–13, 10 reps x 3 sets, 3x/week G - Guided Imagery Incorporated during activities to manage dyspnea I - Inspiratory & Expiratory Exercises + Incentive Spirometer Diaphragmatic Breathing, Pursed-lip Breathing, Incentive Spirometer Frequency: 4x/week, 10 reps x 1 set C - Care Progress review, motivation, adjust plans Rehabilitation Goals Refine thoracic mobility, relieve tension Build endurance, functional capacity Relieve anxiety & improve physical activity Strengthen respiratory muscles Motivate adherence 
Comparator Agent  Conventional physiotherapy   Conventional physiotherapy Weeks 1–2 Inspiratory & Expiratory Exercises + Incentive Spirometer Diaphragmatic Breathing, Pursed-lip Breathing, Incentive Spirometer Frequency: 4x/week, 10 reps x 1 set Activity Aerobic: 70–75% HRmax, 40–60 min, 4x/week Strength: Moderate resistance, RPE 12–13, 10 reps x 3 sets, 3x/week Chest mobility exercise Forward bending in sitting Side stretching Pectoral stretching Frequency: 4x/week, 10 reps x 1 set Weeks 3–4 A - Activity Aerobic: 65–75% HRmax, 20–30 min, 4x/week Strength: Light resistance, RPE 9–11, 2 sets of 10–12 reps, 3x/week I - Inspiratory & Expiratory Exercises + Incentive Spirometer Diaphragmatic Breathing, Pursed-lip Breathing, Incentive Spirometer Frequency: 4x/week, 10 reps x 1 set Chest mobility exercise Forward bending in sitting Side stretching Pectoral stretching Frequency: 4x/week, 10 reps x 1 set Weeks 5–6 A - Activity Aerobic: 70–75% HRmax, 40–60 min, 4x/week Strength: Moderate resistance, RPE 12–13, 10 reps x 3 sets, 3x/week I - Inspiratory & Expiratory Exercises + Incentive Spirometer Diaphragmatic Breathing, Pursed-lip Breathing, Incentive Spirometer Frequency: 4x/week, 10 reps x 1 set Chest mobility exercise Forward bending in sitting Side stretching Pectoral stretching Frequency: 4x/week, 10 reps x 1 set 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with a confirmed diagnosis of COPD, classified as mild or moderate based on the GOLD criteria ,PEFR in mild COPD - 400 and 500 L per min, moderate COPD - 300 to 400 L per min.Breath hold test , mild COPD -30-40 seconds ,moderate COPD - 20 to 30 seconds.clinically stable condition .Ability to provide written informed consent and willingness to participate in the full duration of the study. 
 
ExclusionCriteria 
Details  Patients with severe or very severe COPD (GOLD 3 or 4) or other coexisting respiratory conditions like 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 3 months.Cognitive impairments or psychiatric conditions,unstable medical condition 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Peak Expiratory Flow Rate (r-0.7),Breath hold test (r-0.8)  week 0 and week 6 
 
Secondary Outcome  
Outcome  TimePoints 
2.COPD Assessment Test (r-0.8)Modified medical research council Dyspnea scale (r-0.75),  week 0 and week 6 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION

Chronic 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 STUDY

Chronic 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 QUESTION

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

AIM AND OBJECTIVES

Aim:
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.

HYPOTHESES

Null 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 METHODOLOGY

Study 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 MEASURES

Primary 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 CRITERIA

Inclusion 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.

PROCEDURE

The 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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2. Buran Cirak Y, Yilmaz Yelvar G D, Durustkan Elbasi N. Effectiveness of twelve week inspiratory muscle training with manual therapy in patients with COPD: A randomized controlled study. The Clinical Respiratory Journal. 2022 Apr;16(4):317-328.

3. Morais N, Cruz J, Marques A. Posture and mobility of the upper body quadrant and pulmonary function in COPD: An exploratory study. Brazilian Journal of Physical Therapy. 2016

4. Verma A, Gudi N, Yadav U N, Roy M P, Mahmood A, Nagaraja R, Nayak P. Prevalence of COPD among population above thirty years in India: A systematic review and meta analysis. Journal of Global Health. 2021

5. Cruz Montecinos C, Godoy Olave D, Contreras Briceno F A, et al. The immediate effect of soft tissue manual therapy intervention on lung function in severe chronic obstructive pulmonary disease. International Journal of Chronic Obstructive Pulmonary Disease. 2017

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7. Volpato E, Banfi P, Nicolini A, Pagnini F. A quick relaxation exercise for people with chronic obstructive pulmonary disease: Explorative randomized controlled trial. Multidisciplinary Respiratory Medicine. 2018

8. Dellweg D, Reissig K, Hoehn E, Siemon K, Haidl P. Inspiratory muscle training during rehabilitation in successfully weaned hypercapnic patients with COPD. Respiratory Medicine. 2017

9. Zhou S, Checkley W, Mannino D M, et al. The quality of care and economic burden of COPD in the United States: Considerations for managing patients and improving outcomes. American Health and Drug Benefits. 2021

10. Gordon B, American College of Sports Medicine. ACSM’s Resources for the Exercise Physiologist. Lippincott Williams and Wilkins; 2021.

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12. Kisner C, Colby L A, Borstad J. Therapeutic Exercise: Foundations and Techniques. F A Davis; 2022.

 
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