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
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.
1. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. (2021). Retrieved September 19, 2018.
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
6. American Journal of Respiratory and Critical Care Medicine. Physical activity and chronic obstructive pulmonary disease: A review of benefits and recommendations for a physical activity program. American Journal of Respiratory and Critical Care Medicine. 2021
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.
11. American College of Sports Medicine. ACSM’s Guidelines for Exercise Testing and Prescription. Lippincott Williams and Wilkins; 2014.
12. Kisner C, Colby L A, Borstad J. Therapeutic Exercise: Foundations and Techniques. F A Davis; 2022.