The aim of this study is to check the combined effects of inspiratory muscle training and expiratory muscle training through the breather device vs diaphragmatic breathing on the pulmonary function and severity of the disease in patients with pneumonia
Design
parallel group, randomized clinical trial
Settings and conduct
research will be conducted in Gulab Devi Chest Hospital Lahore in which subjects will be randomly allocated to both group through lottery method
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• Adults aged 35-55 years
• Both gender male and female
• Patients having stage 2 to 4 according to pneumonia severity index
• Participants willing to be the part of the research
Exclusion Criteria
• Participant with acute heart disease (Heart Failure) and acute coronary artery disease
• Participants with other respiratory condition (Asthma, COPD)
• Participants with the diseases leading to the impairment of respiratory muscle (Mysthenia Gravis)
Intervention groups
Intervention Group (IMT and EMT combined through the breather device)
3d/week for upto 3 weeks through the breather device by starting with 15% maximum inspiratory and expiratory resistance. At the starting of intervention Pt will perform 5-6 diaphragmatic breathing in upright position. The patient will be asked to inhale deeply and then hold for 2-3 second and breathe out through the device with the 3 sets with each set including 8 repetitions of IMT and 8 repetitions of EMT in same cycle with diaphragmatic breathing between each set.
Control group (Diaphragmatic breathing)
The group B will be the control group that will receive baseline treatment of diaphragmatic breathing alone.
Main outcome variables
Pulmonary function and severity of Pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230622058556N1
Registration date:2023-07-24, 1402/05/02
Registration timing:prospective
Last update:2023-07-24, 1402/05/02
Update count:0
Registration date
2023-07-24, 1402/05/02
Registrant information
Name
Tehreem Khawar
Name of organization / entity
Riphah college of rehabilitation and allied health sciences
Country
Pakistan
Phone
+92 331 4833135
Email address
tehreemkhawar98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-28, 1402/05/06
Expected recruitment end date
2023-08-20, 1402/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combined effects of inspiratory and expiratory muscle training on pulmonary function and disease severity in patients with pneumonia
Public title
Combined effects of inspiratory and expiratory muscle training on pulmonary function and disease severity in patients with pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Adults aged 35-55 years
• Patients having stage 2 to 4 according to pneumonia severity index
• Participants willing to be the part of the research
• Both gender male and female
Exclusion criteria:
• Participant with acute heart disease (Heart Failure) and acute coronary artery disease
• Participants with other respiratory condition
• Participants with the diseases leading to the impairment of respiratory muscle (Mysthenia Gravis)
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
total 50 patients are randomly allocated to Group A (n=25) and Group B (n=25) through individual simple randomization method of concealed lottery technique.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research & Ethics Committee Riphah College of Rehabilitation and Allied Health Sciences
Street address
26 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab
The Primary outcomes will be measured at two points before starting the treatment and after the treatment ends.
Method of measurement
Pulmonary function will be assessed through digital spirometer (FEV1, FVC, FEV1/FVC)
2
Description
Disease Severity
Timepoint
The Primary outcomes will be measured at two points before starting the treatment and after the treatment ends.
Method of measurement
disease severity through Pneumonia Severity index, and Modified Borg scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention was given 3 days per week for upto 3 weeks starting with 15% of maximum inspiratory load and maximum expiratory load then was incrementally increased 5-10% per weeks to reach 60% at the end of the training. The Patient at first were asked to do 5-6 diaphragmatic breathing in upright position and then asked to breathe with the breather device at 15% of MIR by adjusting the dial. The patient were asked to inhale for 2-3 and then hold for 2-3 second and breathe out through the device with the 3 sets with each set including 8 repetitions of inspiratory muscle training and 8 repetitions of expiratory muscle training in same cycle with relaxed diaphragmatic breathing between each set.
Category
Treatment - Devices
2
Description
Control group: will receive baseline treatment of diaphragmatic breathing alone. The Patient will be asked to do 5-6 diaphragmatic breathing in upright position.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gulab Devi Chest Hospital Lahore
Full name of responsible person
Dr. Muhammad Arif PT Consultant CardioPulmonary Physical Therapist