Protocol summary

Study aim
To find out comparative effect of Buteyko Breathing Technique and Lotorp Method among COPD patients
Design
40 participants will be recruited. Two parallel groups, double blinded, randomized clinical trial with pre and post assessment.
Settings and conduct
Pulmonary Ward Gulab Devi Educational Complex
Participants/Inclusion and exclusion criteria
Inclusion Criteria Patients between age group of 40-65 years. Patients of both genders. Patients with mild or moderate COPD according to the GOLD criteria Exclusion Criteria: Patients with restrictive lung disease. Patients with any infection. Patients having uncontrolled asthma. Pregnant women. Risk of pneumothorax Low resting oxygen saturation(13) Unstable conditions, active infections and neurological condition Patients who cannot comply this technique
Intervention groups
Group A: It will be treated by Buteyko Breathing Technique Group B: It will be treated with Lotorp Method
Main outcome variables
Dyspnea measured using Modified Medical Research Council (MMRC) scale, Chest Expansion measured using Measuring tape, Pulmonary Function Tests using Diagnostic Spirometer and St George Respiratory Questionnaire

General information

Reason for update
Acronym
Effects of Lotorp Method Among COPD.
IRCT registration information
IRCT registration number: IRCT20191117045462N24
Registration date: 2024-08-29, 1403/06/08
Registration timing: retrospective

Last update: 2024-08-29, 1403/06/08
Update count: 0
Registration date
2024-08-29, 1403/06/08
Registrant information
Name
Wajeeha Zia
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
wajeeha_z@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-16, 1403/04/26
Expected recruitment end date
2024-07-16, 1403/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effect of Buteyko Breathing Technique and Lotorp Method Among COPD
Public title
Comparative Effect of Buteyko Breathing Technique and Lotorp Method Among COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between age group of 40-65 years Patients of both genders. Patients with mild or moderate COPD according to the GOLD criteria
Exclusion criteria:
Patients with restrictive lung disease. Patients with any infection. Patients having uncontrolled asthma. Pregnant women Risk of pneumothorax Low resting oxygen saturation unstable conditions, active infections and neurological condition Patients who cannot comply this technique
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited into two groups labeled as 0 for group A and 1 for group B by simple random sampling through sealed opaque enveloped.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double blinded. The assessor physiotherapist and the patient both will be blinded. Although the consent form will be taken from the patient. But the patient will not be aware of the study. Accessor physiotherapist will be involved in the study. He or She must have 2 or 3 year experience in relevant domain. He will access the patient by defined outcome measure tools before the start of study at the end
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Riphah college of rehabilitation & Allied Health Sciences
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54660
Approval date
2024-07-16, 1403/04/26
Ethics committee reference number
RCS&AHS/REC/MS-CPPT

Health conditions studied

1

Description of health condition studied
Chronic Pulmonary Obstructive Disease
ICD-10 code
Chronic br
ICD-10 code description
J44.8

Primary outcomes

1

Description
Pulmonary function
Timepoint
Pre- Post Treatment
Method of measurement
Spirometer ( Diagnostic)

2

Description
Dyspnea
Timepoint
Pre- Post Treatment
Method of measurement
Modified Medical Research Council Scale (MMRC)

3

Description
Chest expansion
Timepoint
Pre- Post Treatment
Method of measurement
Measuring Tape

4

Description
Disease Specific
Timepoint
Pre- Post Treatment
Method of measurement
St Georges Respiratory Questionnaire (SGRQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: Buteyko breathing technique: Treatment to this groups will be performed twice a day, 3-5 times per week, for 3-4 months. . The idea behind it is that people tend to hyperventilate –to breathe faster and more deeply than necessary. Subjects in the Buteyko a groups were trained for 3–5 days and instructed to practice the exercises for 15 minutes twice daily, and for three months duration. Step 1: The ‘‘Control pause (CP)’’ breathing test Step 2: Shallow breathing Sit up straight Step 3: Putting it together Take Control pause Each patient was trained by Buteyko breathing technique twice per week, and the session was about (20 min). The first week each patient of this group trained by Buteyko breathing technique intensively for 4 days then the following 3 weeks were 2 sessions per week. The time of the session was in the morning at least two hours after meals. Each patient performed the BBT by himself at home twice daily (in the morning and in the evening, at least 2 h after meals) during the time of the study Buteyko Breathing Technique.
Category
Rehabilitation

2

Description
Intervention group B : Lotorp Method: Lotorp Method is a two-part therapy involving daily breathing exercises and massage of thoracic muscles at the clinic every third week. The treatment at the clinic is performed for a time of about 60 min. It starts massage based on classic Swedish massage, combined with trigger point treatment if the therapist finds specially tense points in the muscles. On the larger muscles are performed a little faster rubbing movement. The patient lies on his/ her stomach when the back is treated. Back muscles and tendons treated with deep massage are: Erector şpinae, (the sacro spinal system),Rhomboids major and minor, Quadratus lumborum, and external intercostal muscles, Sternum (several muscles attach to the sternum, and a rubbing movement is used to stimulate these attachments),Subclavius, Serratus anterior (upper parts), Scalene Sternocleidomastoids, Diaphragm (external front part), abdominal muscles (transverses abdominis, oblique, internusabdominis, externus abdominis and rectus abdominis). After this exhalations are manually assisted during exhalation by pressing the chest, slowly but powerfully. The hands are placed along the side of the chest and deep exhalations are performed 10 times. Then the hands are moved to the upper parts of the chest. A similar manual pressure during exhalation is performed 5 times. After this the patient is instructed to breathe in and out so that the thorax is moving as much as possible. Treatment to this groups will be performed twice a day, 3-5 times per week, for 3-4 months.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Gulab Devi Trust Hospital Lahore
Full name of responsible person
Gulab Devi Trust Hospital Lahore
Street address
F8MV+5HW, Ferozepur Rd, Nishtar Town, Lahore, Punjab 54000
City
Lahore
Postal code
05307
Phone
+92 42 99230247
Email
jannatfarooq89@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
Gulab Devi Trust Hospital
Full name of responsible person
Gulab Devi Trust Hospital Lahore
Street address
F8MV+5HW, Ferozepur Rd, Nishtar Town, Lahore, Punjab 54000
City
Lahore
Postal code
54660
Phone
+92 42 99230247
Email
jannatfarooq89@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54660
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com
Grant name
Nill
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah International University Lahore
Proportion provided by this source
15
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Umer Arshad
Position
Head of Department
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
EXPERT CONSULTANT CLINIC 627, Khayaban e Jinnah, Iqbal Avenue Cooperative Housing Society - Phase 1, Airline Society, Lahore Punjab
City
Lahore
Province
Punjab
Postal code
57600
Phone
+92 42 111 747 424
Email
omerkhushi0101@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Jannat Farooq
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 42 111 747 424
Email
jannatfarooq89@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...