The aim of this study is to determine the effects of Inspiratory Muscle Training on Dyspnea and Daily Living Activity in the Management of Asthmatic Patients.
Design
Randomized, two parallel groups, single-blind, controlled trial with pre and post-assessment
Settings and conduct
WAPDA Teaching Hospital Complex, Lahore
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The age group of 20 to 40 years;
Diagnosed with asthma according to the Global Initiative for Asthma criteria;
Moderate cases (FEV1=50–79);
Well-controlled hypertension or diabetes mellitus if exist;
At least 12 months asthma diagnosed by a physician.
Exclusion criteria:
Pregnancy;
Rib Fracture;
Risk Of Pneumothorax;
Neuromuscular disease;
Unstable cardiovascular disease;
Musculoskeletal disease;
Pneumonectomy;
Red flags like fever, night sweats, malaise.
Intervention groups
Intervention group: conventional asthmatic rehabilitation program along with inspiratory muscle training.
Control group: conventional asthmatic rehabilitation program.
Main outcome variables
Functional pulmonary assessment using measurement of exercise capacity;
5 Times Sit to Stand Test for dyspnea;
London Chest Activity of Daily Living scale for daily life.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191117045462N3
Registration date:2021-07-13, 1400/04/22
Registration timing:retrospective
Last update:2021-07-13, 1400/04/22
Update count:0
Registration date
2021-07-13, 1400/04/22
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
2021-04-29, 1400/02/09
Expected recruitment end date
2021-06-30, 1400/04/09
Actual recruitment start date
2021-04-29, 1400/02/09
Actual recruitment end date
2021-06-30, 1400/04/09
Trial completion date
2021-07-10, 1400/04/19
Scientific title
Effects of Inspiratory Muscle Training on Dyspnea and Daily Living Activity in the Management of Asthmatic Patients.
Public title
Effects of Inspiratory Muscle Training on Dyspnea and Daily Living Activity in the Management of Asthmatic Patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with asthma according to the Global Initiative for Asthma criteria.
Moderate cases FEV1 =50–79
Well-controlled hypertension or diabetes mellitus if they have
At least 12 months asthma diagnosed by a physician
Exclusion criteria:
Pregnancy
Rib Fracture
Risk Of Pneumothorax
Neuromuscular disease
Unstable cardiovascular disease
Musculoskeletal disease
Pneumonectomy
Red flags like: fever, night sweats, malaise
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
30
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be recruited in the study through a convenient sampling technique and then will be randomly
assigned to each group through Random Sampling sealed opaque enveloped. Labeled as 1 group A and 2 for group B. Half enveloped will be labeled with 1 and a half with labeled 2. If a patient gets the envelope with label 1 then will be treated in group A, and if a patient gets the envelope with label 2 that will be treated in group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Investigator will be blind.
Assessment will be done by another therapist who will not be involved in treatment and data analysis.
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
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Approval date
2642-02-16, 2020/11/27
Ethics committee reference number
RCR&AHS/REC/MS-CPPT
Health conditions studied
1
Description of health condition studied
asthmatic patient
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
effects of Inspiratory muscle training
Timepoint
Pre- Post treatment
Method of measurement
London Chest Activity of Daily Living scale
Secondary outcomes
1
Description
Dyspnea and Daily Living Activity
Timepoint
Pre-Post Treatment
Method of measurement
• Functional pulmonary assessment to measure exercise capacity• 5 Times Sit to Stand Test for dyspnea • London Chest Activity of Daily Living scale for daily life
Intervention groups
1
Description
Intervention group: Conventional asthmatic rehabilitation program along with inspiratory muscle training. Conventional asthmatic rehabilitation of the treatment which included pursed lip breathing, diaphragmatic breathing exercises and thoracic expansion exercises. 3 times/week with 10 repetitions/3 set/session/day.
Category
Rehabilitation
2
Description
Control group: Conventional asthmatic rehabilitation program. Conventional asthmatic rehabilitation of the treatment which included pursed lip breathing, diaphragmatic breathing exercises and thoracic expansion exercises along with inspiratory muscle training. The inspiratory muscle training will be performed using a incentive spirometer. The patient will be asked to breath in slowly through incentive spirometer after 10 inspiration. It will be repeated with few seconds of rest. The cycle of 10 inspiration for15 times 3 times/week with 10 repetitions/3 set/session/day.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Nida Ghaffar
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
nidaghaffar9@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
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
Nida Ghaffar
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
nidaghaffar9@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha
Position
Senior Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Nida Ghaffar
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
nidaghaffar9@gmial.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
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