Protocol summary

Study aim
The aim of the study is to comprehensively compare the efficacy of breathing exercises and low-intensity circuit training as therapeutic interventions for asthma patients. This will help patients of asthma to become more independent.
Design
Pragmatic,community based,parallel group,double blinded, randomised control trial. There will be 357 patients that we will enroll.Study will be done form April-July 2024.
Settings and conduct
1. Azeem Hospital Multan 2. Sughran Wazeer Child Clinic Hospital Multan 3. South Punjab Hospital Multan 4. Muhammad Rehabilitation Clinic (Muhammad Institute of Medical and Allied Sciences Multan) after approval from institutional ethical comittee
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients of 18-40 years, diagnosed asthmatic patients, both genders. Exclusion criteria: Patients with vascular neoplasia, fibromyalgia, radiculopathy, neuropathy, tumor, joint fractures, and vestibular problems, heart problems, not willing to participate, pschycological unfit patients, pregnant/lactating ladies were excluded.
Intervention groups
Group-A will be given breathing exercises and group-B will be given low-intensity circuit exercises for 12 weeks. Breathing exercises for group-A includes pursed lip breathing, diaphragmatic breathing and breath holding exercises. For group-B low intensity circuit exercises includes walking, running and abdominal crunches.
Main outcome variables
Lung capacity, forced expiratory volume, exercise capacity and quality of life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N6
Registration date: 2024-06-09, 1403/03/20
Registration timing: registered_while_recruiting

Last update: 2024-06-09, 1403/03/20
Update count: 0
Registration date
2024-06-09, 1403/03/20
Registrant information
Name
Imran Ahmad Khan
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 333 6120602
Email address
imran.ahmad@mnsuam.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-12, 1403/01/24
Expected recruitment end date
2024-07-12, 1403/04/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of breathing exercises and low intensity circuit training in asthma patients
Public title
Breathing exercises and low intensity circuit training in asthma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female Age 18-40 years Patients diagnosed with asthma
Exclusion criteria:
Not willing to participate Psychological unfit patient Patients with heart problems/diseases Patient with musculoskeletal disorders Pregnant/ lactating ladies Patients with any trauma/neoplasms
Age
From 18 years old to 40 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 357
More than 1 sample in each individual
Number of samples in each individual: 3
At day 1, 6th week and at the end (12th week ) parameters will be checked
Randomization (investigator's opinion)
Randomized
Randomization description
Double blinded study will be conducted randomization of participants in two groups will be done by lottery method
Blinding (investigator's opinion)
Double blinded
Blinding description
In a double-blinded study, participants will be blinded. Participants will be unaware of the type of treatments that will be evaluated after the completion of the intervention trial. subjects will choose between two samples and also the investigator will be kept blind as he will not know who is receiving the treatment and who is receiving a placebo or alternative treatment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences,
Street address
Bosan Road
City
Multan
Postal code
66000
Approval date
2024-02-02, 1402/11/13
Ethics committee reference number
MIMAS/03/IRB/Farah

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Lung capacity
Timepoint
12 weeks
Method of measurement
Spirometery

2

Description
Forced expiratory volume
Timepoint
12 weeks
Method of measurement
Spirometery

3

Description
Exercise capacity
Timepoint
12 weeks
Method of measurement
6-minute walk test and shuttle walk test

Secondary outcomes

1

Description
Quality of life
Timepoint
12 weeks
Method of measurement
Asthma Quality of Life Questionnaire (AQLQ)

2

Description
Asthma Related Anxiety and Depression
Timepoint
12 weeks
Method of measurement
Asthma Related Anxiety and Depression Scale

Intervention groups

1

Description
Intervention group: Group-A will be treated with breathing exercises for 3 times/ week each session lasted for 45 minutes and total duration is 12 weeks
Category
Treatment - Other

2

Description
Intervention group: Group-B will be treated with low-intensity circuit exercises including cycling argometer, low intensity walking, running squats for 3 times/ week each session lasted for 45 minutes and total duration is 12 weeks12 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Muhammad Rehabilitation Clinic
Full name of responsible person
Dr. Gul-e-Mizgan
Street address
Bosan road
City
Multan
Postal code
66000
Phone
+92 333 6102847
Email
gulemizgan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ali –Ul- Murtaza Department of Rehabilitation Science, MIMAS
Full name of responsible person
Gul-e-Mizgan
Street address
Bosan road
City
Multan
Postal code
66000
Phone
+92 337 6231111
Email
mimasmultan99@gmail.com
Grant name
Student fund
Grant code / Reference number
03/MIMAS/ANAS
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ali –Ul- Murtaza Department of Rehabilitation Science, MIMAS
Proportion provided by this source
50
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
Muhammad Nawaz Shareef University of Agriculture,Multan
Full name of responsible person
Imran Ahmad Khan
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Agriculture Complex, Old Shuja Abad Rd, Multan, Punjab
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imran.ahmad@mnsuam.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Institute Of Medical And Allied Sciences Multan
Full name of responsible person
Farah Zahid
Position
Lecturer
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
Bosan road
City
Multan
Province
Punjab
Postal code
66000
Phone
0337-623111
Email
farahzahid977@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute Of Medical And Allied Sciences Multan
Full name of responsible person
Anas Sajjad
Position
Final year student of DPT
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Bosan road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 306 6887085
Email
anaskhanqalandrani01@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
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